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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Male or female ≥18 years-of-age Multiple myeloma with evaluable disease Relapsing or having a progressive disease Karnofsky performance status > 50 % Life expectancy of at least 3 months Female of child-bearing potential must have a method of birth control and a negative serum or urine beta--human chorionic gonadotropin (β-HCG) pregnancy test at screening and all through the study Male must use contraception Voluntary written informed consent Non-secretory multiple myeloma Platelet count < 40,000 X 10^9/L Absolute neutrophil count <1.0 X 10^9/L Creatinine clearance <30 mL/minute Peripheral neuropathy >= Grade 2 Seropositive for HIV, or active hepatitis A, B or C infection Pregnant or breastfeeding female Patient has hypersensitivity to bortezomib, boron or mannitol Other investigational drugs Serious medical or psychiatric illness
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-120.0, Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Chronic idiopathic myelofibrosis or myelodysplastic/myeloproliferative disorders (MDS/MPD), including the following subtypes Chronic idiopathic myelofibrosis (with extramedullary hematopoiesis) Chronic myelomonocytic leukemia (CMML) Atypical chronic myeloid leukemia MDS/MPD disease, unclassifiable MDS with ≥ 2+ fibrosis present in the bone marrow Patients with MPD must be negative by fluorescent in situ hybridization (FISH) for the BCR/ABL fusion gene ECOG performance status 0-2 Life expectancy of at least 3 months Platelet count > 10,000/mm³
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Relapse Refractory Multiple Myeloma Subjects must meet all of the following to be eligible for enrollment into the study 1. Understand and voluntarily sign an informed consent form. 2. Age > 18 years at the time of signing the informed consent form. 3. Multiple myeloma with Durie-Salmon stage II or III and considered to have disease progression after at least 1 previous anti-myeloma regimen (examples: induction chemotherapy followed by stem cell collection and high dose chemotherapy and autologous PBSCT; MP; anthracycline-containing regimen > 3 months ago, any other conventional regimen including thalidomide or bortezomib containing regimens. 4. Subjects must have not have recieved more than 3 previous anti-myeloma regimens and must be relapsed or refractory following at least one regimen of anti-myeloma therapy. 5. No anthracycline-containing regimen (e.g. VAD) within the last 3 months of study. 6. Subjects may have been previously treated with thalidomide or bortezomib. 7. Radiation therapy after start of the protocol will be considered as treatment failure except when given to treat pathological fractures or preexisting osteolytic lesions. 8. Patients must have measurable levels of myeloma paraprotein in serum (>0.5 g/dl) or urine (>0.2 g excreted in a 24-hour collection sample). 9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. 10. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting each cycle. Men and WCBP must agree to use adequate contraceptive methods. 11. Must have a 2-d echocardiogram indicating LVEF ≥ 55% within 42 days prior to first dose of study drug. 12. Life extpectancy > 3 months The presence or any of the following will a subject from study enrollment. 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that makes the patient ineligeble for the study. Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma. 2. Pregnant or lactating females. 3. Heart failure (EF < 55%). 4. Any of the following laboratory abnormalities Absolute neutrophil count (ANC) <1500/mm3 (1x109/L) Platelet count (PLT) <100000/mm3 Serum creatinine> 2.5 mg/dL SGOT and SGPT > 3 x upper limit of normal (ULN) Serum total bilirubin >1.2 mg/dL 5. Prior history of any other malignancies except for adequately treated basal cell, insitu cervical or breast cancer or other for which the patient has been disease free for 5 years. 6. Known hypersensitivity to thalidomide, dexamethasone and/or anthracyline. 7. Prior use of Revlimid. 8. Anthracycline-containing regimen (e.g. VAD) within the last 3 months of study. 9. Any history of thrombembolic events 10. Use of any standard or experimental anti-myeloma drug therapy within 28 days of study enrolment. 11. Major surgery or radiotherapy within 4 weeks of study enrolment. 12. Active infection requiring antibiotic therapy. 13. Subjects who have received > 300 mg/m2 lifetime cumulative dose of doxorubicin alone, or Doxil® alone, or doxorubicin plus Doxil®. 14. History of cardiac disease, with New York Heart Association Class II or greater (See Appendix VII). 15. Known HIV or hepatitis B or C positive. 16. No more than 3 prior anti-myeloma regimens
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-75.0, Multiple Myeloma Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy Presence of measureble disease : serum M-protein > 1g/dL or urine M-protein > 400mg/day Age < 75 Performance status </= ECOG 2 Expected survival > 6 months who signs the informed consent known hypersensitivity to thalidomide or dexamethasone known refractoriness to thalidomide + dexamethasone Previous Velcade therapy Sepsis Woman in reproductive age Serum creatinine > 2 mg/dL ; 24 hour creatinine clearance < 30 ml/min; past medical history of kidney transplatation Peripheral neuropathy >/= grade 2 Recurrent DVT or pulmonary embolism Cardiac ejection fraction <0.5 : Severe conduction disorder Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 65.0-75.0, Multiple Myeloma Newly diagnosed patients with overt multiple myeloma who are not candidates for HDT/SCT because of old age (> 65) or presence of comorbid conditions likely to have a negative impact on tolerability of HDT/SCT. Sponsors review this conditions and approval is required Presence of measurable disease : serum M-protein > 1g/dL or urine M protein > 400mg/day Performance status £ ECOG 2 Expected survival ³ 6 months Pretreatment clinical laboratory values meeting the following within 14 days before enrollment platelet ≥ 100 x 109/L hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L) Prior RBC transfusion or recombinant human erythropoietin use is allowed) absolute neutrophil count (ANC) ≥ 1.0 x 109/L aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤ 3mg/dL corrected serum calcium <14 mg/dL (<3.5 mmol/L) Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Smoldering or indolent myeloma History of allergic reaction attributable to compounds containing boron or mannitol Known hypersensitivity to thalidomide or dexamethasone Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg Sepsis Pregnancy or breastfeeding Uncontrolled Diabetes Mellitus Recurrent DVT or pulmonary embolism Active ulcers detected by gastroscopy
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Breast Neoplasms Postmenopausal women with advanced hormone receptor positive (ER and or PgR) breast cancer, has received prior treatment with an aromatase inhibitor in the advanced disease setting, and experienced at least 24 weeks of progression free survival. As long as the patient experienced an aromatase inhibitor response as defined this way, she is still eligible even if she has received further lines of endocrine therapy, which may other aromatase inhibitors or tamoxifen, even if these subsequent lines of treatment were unsuccessful (see below for permitted chemotherapy and trastuzumab therapy). OR Postmenopausal women with systemic or unresectable local relapse after taking at least two years of adjuvant aromatase inhibitor therapy Clinical diagnosis of postmenopausal status is defined as either: 1. Age greater than 50 years and amenorrhea for 1 year 2. Bilateral Surgical ovariectomy 3. Serum FSH and estradiol level in the postmenopausal range before the initiation of AI therapy. 4. If the patient was receiving an LHRH agonist to maintain a postmenopausal state during AI therapy this should be continued since recovery of menses would lead to uncontrolled estrogen exposure and pregnancy during estrogen therapy is contraindicated Tumor cell expression of ER and/or PgR can be ascertained on either the primary or the metastatic site. However when both types of tissue are available, the metastatic site should be used to determine eligibility. ER and/or PgR positive are defined as at least 10% of malignant cells with positive nuclear staining The patients may have received adjuvant and/or neoadjuvant chemotherapy Prior radiotherapy is permitted as long as it was planned before the start of the study medication and is completed within 3 weeks of trial medication starting Prior tamoxifen therapy is also permitted as adjuvant or advanced disease therapy Patients with ER+ HER2+ disease are eligible even of they have received trastuzumab in the past (and even if it was administered in combination with endocrine treatment) as long as they meet all other criteria. Trastuzumab therapy must be held during estradiol treatment Use of prior experimental agents alone or in combination with endocrine therapy is also permissible, but a wash out of one month is required if the immediate prior therapy involved a study medication that had not been subject to regulatory approval Prior adjuvant chemotherapy is permitted as well as one line of chemotherapy for advanced disease Patients with CNS involvement with metastatic breast cancer or life threatening lymphangitic or large volume lung or liver disease that threatens organ function Patients with history of deep venous thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension Ischemic changes on a baseline EKG or other evidence of ischemic heart disease Undiagnosed abnormal genital bleeding Untreated cholelithiasis Fasting serum triglycerides greater than 400. Patients should be treated and triglycerides controlled prior to study entry Treatment with fulvestrant within 12 months of study initiation (fulvestrant has been shown to antagonize estradiol induced apoptosis in preclinical models (5) The patient's only qualifying lesion (s) have been previously irradiated or are scheduled for irradiation following study entry Severe or uncontrolled concomitant disease from other causes EGOG Performance status 3 or 4
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Multiple Myeloma = Newly diagnosed with drug sensitive disease (>50% tumor response to standard chemotherapy) and poor prognostic indicators, such as Salmon-Durie stage III, serum b-2-microglobulin >3.0 mg/L, high proliferative fraction or hypodiploidy. Relapsed patients after a response to standard chemotherapy. Patients with primary refractory disease. Patients with non-secretory multiple myeloma are eligible for enrollment on this study. They will be followed for toxicity, survival and molecular endpoint analyses, but will not be followed for response. Patients with plasma cell leukemia, either occurring de novo or arising from existing multiple myeloma, are ineligible for this study Patients greater than or equal to 18 years of age are eligible Patients must have histologically confirmed diagnosis by a pathologic review at the H. Lee Moffitt Cancer Center and Research Institute Patients must have undergone a complete psychosocial evaluation and been considered capable of compliance Patients willing and able to receive palifermin (young cohort only) Patients with a diffusing lung capacity oxygenation (DLCO) less than 50% (adjusted) of normal or with symptomatic obstructive or restrictive disease are ineligible Patients with a serum creatinine of greater than 2.0 mg/dL OR a creatinine clearance of less than 40 ml/minute. Creatinine clearance can be measured or calculated. Patients with renal dysfunction secondary to multiple myeloma may be enrolled at the discretion of the principal investigator. However, patients on hemodialysis or peritoneal dialysis are ineligible Patients with a total bilirubin greater than 2.0 mg/dL and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) greater than two and a half times normal (unless due to primary malignancy), or a history of severe hepatic dysfunction are ineligible Patients who have evidence of severe cardiac dysfunction are ineligible. A gated blood pool (MUGA) scan must show an ejection fraction of at least 50%. Patients must be free of major heart disease. Patients are ineligible if they have received a total dose of doxorubicin of greater than 450 mg/m2 (or daunorubicin equivalent) unless the left ventricular ejection fraction by MUGA scan is at least 50%. Patients must not be taking nitroglycerin preparations for angina pectoris or antiarrhythmic drugs for major ventricular dysrhythmias. Patients with essential hypertension controlled with medications are eligible for study. Any patient with congenital or acquired heart disease or cardiac arrhythmias will have a cardiology consult and evaluation Patients with active infections are ineligible Patients who are HIV antibody positive are ineligible Patients with active leptomeningeal involvement are ineligible. Patients with a history of previous cerebrospinal fluid (CSF) tumor involvement without symptoms or signs are eligible provided the CSF is now free of disease on lumbar puncture and MRI of the brain shows no tumor involvement. Patients with severe symptomatic central nervous system (CNS) disease of any etiology are ineligible Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction are ineligible Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of > or = 2 are ineligible. Patients with ECOG performance status 2 to 3 secondary to bone pain may be enrolled at the discretion of the institutional investigator. Patients with ECOG performance status 2 to 3 secondary to a potentially reversible disease-related problem may be enrolled at the discretion of the institutional investigator Patients who are pregnant or lactating are ineligible
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of multiple myeloma Stage I, II, or III disease according to Durie-Salmon staging Progressive disease, defined as one of the following For secretory disease A 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 g/dL serum M-protein or ≥ 200 mg/24 hours of urine light chain excretion) For nonsecretory disease Bone marrow biopsy with > 25% increase in plasma cells or an absolute increase of ≥ 10% over prior known level Development of new or worsening existing lytic bone lesions or soft tissue plasmacytomas Hypercalcemia (i.e., calcium > 11.5 mg/dL) Relapsed after complete response
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-80.0, Multiple Myeloma Patient was previously diagnosed with multiple myeloma based on standard and currently requires second or *third line therapy because of PD, defined as a 25% increase in M-protein, or development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dL), or relapse from CR.*Patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies Patient is of a legally consenting age, as defined by local regulations Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study Male patient agrees to use an acceptable method for contraception for the duration of the study Patient has measurable disease Patient has a Karnofsky performance status ≥60% Patient has a life-expectancy >3 months Primary Dexamethasone resistance Prior therapy with Bortezomib Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol Neuropathy > Grade 2 with pain by NCI-CTCAE
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Acute Renal Failure Contrast Nephropathy Eligible patients individuals aged 18 year or older with GFR 15-60ml/min calculated by MDRD formula, who were scheduled to undergo cardiac catheterization. During the randomized study, consecutive eligible patients scheduled for exposure to the nonionic radiographic contrast agent iopamidol (796 mOsm/kg H2O, 755 mg of iopamidol per milliliter, and 370 mg iodine per milliliter) will be considered for enrollment i. Serum creatinine levels more than 8mg/dl or GFR less than 15ml/min ii. Change in serum creatinine levels of ³0.5mg/dl during the previous 24 hours. iii. Preexisting dialysis iv. Multiple myeloma. v. Pulmonary edema. vi. Uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg.) vii. Emergency catheterization. viii. Recent exposure to radiographic contrast (within two days of the study). ix. Allergy to radiocontrast. x. Pregnancy. xi. Administration of dopamine, mannitol or NAC before the study. -
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patient is of a legally consenting age as defined by local regulations Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study Patient was previously diagnosed with multiple myeloma based on standard criteria Patient is relapsed or refractory after one or two lines of treatment including high-dose chemotherapy with stem cell support, conventional poli-chemotherapy, thalidomide and melphalan-based regimens Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours Patient has a Karnofsky performance status ≥60% Patient has an absolute neutrophil count <0.75 × 109/L within 14 days before enrollment Patient has a calculated or measured creatinine clearance <20 mL/minute within 14 days before enrollment Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment Patient has known hypersensitivity to bortezomib, boron, mannitol or thalidomide
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 65.0-75.0, Multiple Myeloma Stage II or III multiple myeloma according to Durie and Salmon criteria Patients between 65 and 75 years of age Previously untreated patients Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) Primary or associated amyloidosis World Health organisation performance index of at least 3 Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more Cardiac or hepatic dysfunction Cerebral circulatory insufficiency Absolute contraindication to corticosteroids Peripheral neuropathy HIV or hepatitis B or C positivity Patients who had geographic, social or psychological conditions which might prevent adequate follow-up
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 15.0-65.0, Multiple Myeloma Previously untreated newly diagnosed patients with MM (stage II-III) 2.Age < 65 3.Eastern Cooperative Oncology Group Performance Status 0-1 4.EF > 50%, FVC and FEV > 50%, DLCO >50% 5.Platelet count ≥ 100 x 109/L (pretreatment platelet transfusion is not allowed, while transfusion during the treatment is permitted), hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L), Prior RBC transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (ANC) ≥ 1.0 x 109/L 6.Adequate liver function (bilirubin < UNL(Upper Normal Limit) x 2 and ALT/AST < UNL x 3) 7.Adequate renal function (serum creatinine < UNL x 1.5 or creatine clearance > 60 ml/min) 8.Signed the informed consent, have the will and ability to follow the protocol History of allergic reaction attributable to compounds containing boron or mannitol 2. Known hypersensitivity to thalidomide or dexamethasone 3. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 4. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 5. Acute severe infection requiring antibiotic therapy 6. Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin) 7. Pregnancy or breastfeeding 8. Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion) 9. Previous renal transplantation 10. Recurrent deep vein thrombosis or pulmonary embolism 11. Uncontrolled diabetes mellitus 12. Receipt of extensive radiation therapy within 4 weeks ((Extensive means RT to more than 2 anatomic sites)
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-64.0, Multiple Myeloma Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Age over 18 and under 65 years old Patient recently diagnosed with symptomatic Multiple Myeloma based on standard and that has not received any previous chemotherapy treatment for Multiple Myeloma Patient has measurable disease, defined as follows: For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours. For poor or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligosecretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine by immunofixation Patient has a ECOG performance status < 2 Patient has a life-expectancy >3 months Patient has the following laboratory values within 14 days before Baseline visit (Day 1 of Cycle 1, before study drug administration): Platelet count ≥ 50x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L; Corrected serum calcium <14mg/dl. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine value ≤ 2mg/dl Patient previously received treatment with Patient previously received treatment for Multiple Myeloma Patient had major surgery within 4 weeks before enrollment Patient has a platelet count < 50x 109/L within 14 days before enrollment Patient has an absolute neutrophil count < 1.0 x 109/L within 14 days before enrollment Patient has < Grade 2 peripheral neuropathy within 14 days before enrollment Patient has hypersensitivity to bortezomib, boron or mannitol Patient has received other investigational drugs within 14 days before enrollment Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Multiple Myeloma in Relapse Subject was previously diagnosed with multiple myeloma based on standard diagnostic as follows. Major Plasmacytomas on tissue biopsy Bone marrow plasmacytosis (> 30% plasma cells) Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) >3.5 g/dL or immunoglobulin A (IgA) > 2.0 g/dL; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis. Minor Bone marrow plasmacytosis (10 to 30% plasma cells) Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria Lytic bone lesions Normal IgM < 50 mg/dL, IgA < 100 mg/dL or IgG < 600 mg/dL. 2. Any of the following sets of will confirm the diagnosis of multiple myeloma: 3. Any two of the major criteria. 4. Major criterion 1 plus minor criterion b, c, or d. 5. Major criterion 3 plus minor criterion a or c. 6. Minor a, b, and c or a, b, and d. 7. Patients must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment). 8. Patients must have been previously treated with bortezomib. Patients may have received prior perifosine. 9. Age >= 18 years at the time of signing informed consent document. 10. All necessary baseline studies for determining must be obtained within 14 days prior to enrollment. (Pregnancy test must be within 7 days for women of childbearing potential.) 11. Subject has an ECOG (Zubrod) performance status of 0 to 2. 12. Subject must be able to adhere to the study visit schedule and other protocol requirements. 13. Subject must understand and voluntarily sign an informed consent document. 14. Women of child-bearing potential (WCBP) must have a negative serum or urine pregnancy test within 72 hours prior to enrollment. In addition, all sexually active WCBP and male patients must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study Renal insufficiency (serum creatinine levels > 3 mg/dL). 2. Patients who present with either ALT or AST >= 2.5 X upper limit of normal (ULN) and/or patients with bilirubin >= 1.5 X ULN. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine). 4. Concomitant medications that corticosteroids (except as indicated for other medical conditions or up to 100 mgs of hydrocortisone or equivalent as premedication for administration of certain medications or blood products), chemotherapy, or other therapy that is or may be active against myeloma within 2 weeks prior to Cycle 1 Day 1. Nitrosoureas must be discontinued 6 weeks prior to Cycle 1 Day 1. 5. Subjects with hemoglobin < 8.0 g/dL. 6. Subjects with an absolute neutrophil count (ANC) <= 500 cells/mm3. 7. Peripheral neuropathy of grade 3 or greater. Patients with painful grade 2 neuropathy are also excluded. 8. Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count >= 50,000 cells/mm3). 9. Previous history of intolerance of bortezomib or perifosine. 10. Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study. 11. WCBP who are pregnant or breast-feeding or men and women who are not using adequate contraception. 12. Plasma cell leukemia at time of study entry
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma in Relapse Stage II Multiple Myeloma Stage III Multiple Myeloma Histologically or cytologically confirmed symptomatic multiple myeloma Stage II or III disease Relapsed or refractory disease after >= 2 courses of prior chemotherapy Measurable levels of monoclonal protein (M protein) > 1.0 g/dL by serum protein electrophoresis OR > 200 mg of monoclonal light chain by 24-hour urine protein electrophoresis Measurable bone disease, defined as >= 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm with conventional techniques OR >= 10 mm with spiral CT scan (for patients with lytic bone disease) No known brain metastases ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% Patients with PS of 3 are eligible if it is due to pain that is likely to improve with treatment Life expectancy > 6 months No known HIV positivity
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Carcinoma, Small Cell Patients with histologically or cytologically confirmed, -sensitive-relapse SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology Symptomatic brain metastases or leptomenigeal disease Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer) Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin <9 mg/dl Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine >2.0 mg/dl (>176 µmol/L, SI Unit equivalent) Chemo-, hormone (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection Known or suspected active drug or alcohol abuse
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Secondary Hyperparathyroidism Hypercalcemia renal transplant recipient at least 3 months post transplant hypercalcemia hyperparathyroidism allergic to cinacalcet, tetracycline pregnancy on medication that utilize same liver system as cinacalcet Hcl
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Renal Failure Newly diagnosed multiple myeloma (MM), meeting ≥ 2 of the following Serum or urine* paraprotein Bone marrow showing > 10% plasma cells Lytic bone lesions NOTE: *The presence of typical myeloma kidney on renal biopsy is considered equivalent to the demonstration of urine paraprotein by electrophoresis Acute renal failure attributable to MM, meeting both of the following Creatinine > 5.65 mg/dL OR urine output < 400 mL/day OR requires dialysis Unresponsive to treatment with fluids and/or treatment of hypercalcemia with bisphosphonates No significant intrinsic renal disease unrelated to MM Platelet count ≥ 50,000/mm³ Bilirubin ≤ 1.5 times upper limit of normal (ULN)
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Symptomatic myeloma diagnosis according to in attachment 3 ASCT is performed or has been performed in the last five weeks (time limit two weeks for patients randomised at 2nd transplantation) as a part of primary therapy Signed informed consent given prior to any study related activities have been performed Prior exposure to bortezomib Allogeneic transplantation scheduled as a part of the primary treatment Neuropathy > Grade 2 (neurological symptoms interfering with ADL) Non-secreting myeloma Other concurrent disease making bortezomib treatment unsuitable Positive pregnancy test (only applicable for women with childbearing potential) Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg) Serious medical or psychiatric illness likely to interfere with participation in this clinical study
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Eligible subjects will be considered for in this study if they meet all of the following Males or females, age 18 years or older Diagnosis of advanced multiple myeloma, after at least 2 prior therapies for MM Measurable disease M component in serum (at least 0.5 G/dL) and/or urine (≥0.2 g excreted in a 24-hour collection sample) Not eligible for stem cell or bone marrow transplant or have refused stem cell or bone marrow transplant or have relapsed after autologous or allogeneic stem cell or bone marrow transplant ECOG performance status 0-2 (Appendix E) ALT or AST ≤3 x ULN Total bilirubin ≤2 x ULN (unless related to MM) Serum creatinine ≤2.0 mg/dL (unless related to MM, then ≤ 3.0 mg/dL) Must have adequate bone marrow function defined as: Absolute neutrophil count >1,000 cells/mm3; platelets ≥75,000 cells/mm3; and hemoglobin ≥8 g/dL. No platelet transfusion within 72 hours of obtaining screening platelet count Subjects will be ineligible for this study if they meet any one of the following Life expectancy of less than 3 months Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years Plasma cell leukemia (active or prior) Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma (serum creatinine > 2.0 mg/dL) Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia Corticosteroid, Velcade® or other proteosome inhibitor, thalidomide, lenalidomide (Revlimid®), or melphalan within 2 weeks of the first dose of HuLuc63; nitrogen mustard agents within 6 weeks of the first dose of HuLuc63 Investigational drug within 4 weeks or 5 half-lives (whichever is greater) of the first dose of HuLuc63 Stem cell or bone marrow transplant within 12 weeks prior to the first dose of HuLuc63 Biological agents including intravenous immune globulin (IVIG) and monoclonal antibodies within 4 weeks of the first dose of HuLuc63
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with previous diagnosis of multiple myeloma based on standard patient has received at least 2 previous lines of therapy for multiple myeloma and, currently requires therapy because of relapsed or progressive disease If female, the patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit If male, the patient agrees to use an acceptable barrier method for contraception from Screening through the Final Visit patient has a Karnofsky performance status >= 60 patient meets defined pretreatment laboratory If patient received bortezomib in a previous clinical trial, the patient's best response to bortezomib was progressive disease Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment, corticosteroids (>10 mg/day prednisone or equivalent) within 3 weeks before enrollment, immunotherapy or antibody therapy within 4 weeks before enrollment Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI CTC Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities Patient has cardiac amyloidosis
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Relapsed or refractory multiple myeloma following 1 previous line of therapy and, is scheduled by the investigator to be treated with vincristine, adriamycin and dexamethasone standard therapy measurable secretory multiple myeloma based on defined Karnofsky performance status of >or = 60% fulfils defined laboratory requirements within 14 days before baseline if female, the patient is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control for defined period of time if male, the patient agrees to use an acceptable barrier method for contraception for a defined period of time More than one previous line of therapy for multiple myeloma use of bortezomib in the previous line of therapy and/or received bortezomib in a previous trial known allergy or hypersensitivity to bortezomib, boron or mannitol peripheral neuropathy or neuropathic pain of grade 2 or higher myocardial infarction within 6 months of enrollment or had New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically confirmed amyloidosis Diagnosed within the past 12 months Clonal plasma cell disorder, as demonstrated by any of the following Presence of M-protein in serum and/or urine by immunofixation and/or serum free light chain assay Clonal population of plasma cells in the bone marrow based on kappa/lambda staining of a marrow biopsy Negative genetic testing for hereditary forms of amyloidosis No amyloid-specific syndrome (e.g., carpal tunnel syndrome or skin purpura) as the only evidence of disease Vascular amyloidosis only in a bone marrow biopsy specimen or in plasmacytoma is not indicative of systemic amyloidosis No advanced cardiac amyloidosis Must have symptomatic involvement of no more than 2 of the following visceral organ systems
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-65.0, Multiple Myeloma Must be able to comply with the protocol requirements 2. Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care, 3. Age <65 years and possibly to do an autologous transplant. 4. Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma. 5. Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours. 6. ECOG < 2. 7. El patient has a life-expectancy > 3 months. 8. Patient has the following laboratory values before beginning induction treatment: 1. Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed if they are due to marrow infiltration. 2. Corrected serum calcium <14mg/dl. 3. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. 4. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. 5. Total bilirubin: ≤1.5 x the upper limit of normal. 6. Serum creatinine ≤ 2 mg/dl. 9. For Patients included in Thalidomide branches: women of childbearing age must not have sex unless they use two anticonceptive methods beginning 4 weeks before the first dose, during all the study until 4 weeks after the last one Non-secretor Myeloma. 2. Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment. 3. Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment. 4. Patient had major surgery within 4 weeks before enrolment. 5. Patient has hypersensitivity to bortezomib, boron or mannitol or Thalidomide. 6. Patient has received other investigational drugs within 30 days before enrolment. 7. Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection. 8. Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 9. Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason. 10. Pregnancy or breast-feed women
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically confirmed primary systemic amyloidosis Amyloid light-chain (AL) disease Monoclonal protein by immunoelectrophoresis or immunofixation of the serum or urine OR abnormal free light-chain ratio The following amyloid syndromes* are allowed Amyloid hepatomegaly Cardiomyopathy Proteinuria Peripheral or autonomic neuropathy Soft tissue involvement including the tongue, submandibular tissues, and vascular claudication Diffuse interstitial pulmonary AL disease allowed if pulmonary function is adequate to allow safe transplantation NOTE: *Presence of amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic patient does not constitute an amyloid syndrome
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma and Plasma Cell Neoplasm Confirmed diagnosis of multiple myeloma (M-protein by serum protein electrophoresis or urine protein electrophoresis) and either bone marrow biopsy and aspirate demonstrating a plasma cell count > 10% or biopsy of a bone or soft tissue mass demonstrating a plasmacytoma Demonstration of an indication for therapy based on symptoms (e.g., boney pain), hypercalcemia, anemia, renal insufficiency, symptomatic plasmacytomas, multiple boney lytic lesions, etc Stable disease or has achieved a partial remission or complete remission to pre-transplant cyto-reductive therapy Primary refractory disease (no response to therapy but stable) is permitted Candidate for high-dose chemotherapy with autologous stem cell transplantation based on stabilization of disease with preparative chemotherapy (regardless of the specific agents) A minimum of 2 x 10^6 CD34+ cells/kg must be collected prior to proceeding to transplant Evidence of active plasma cell leukemia Relapsed refractory disease (patients who have achieved at least a partial response [PR] to previous therapy and are now refractory [have not achieved a PR to subsequent therapy]) Progressive disease on their last therapy Karnofsky performance status 60-100% Creatinine < 3.0 mg/dL AST and ALT <2.5 times upper limit of normal Total bilirubin < 3 mg/dL WBC ≥ 2,000/mm³ Platelet count ≥ 50,000/mm³ If abnormal hematologic function is attributable to bone marrow infiltration by multiple myeloma, the principal investigator will decide on a case-by-case basis if the patient's bone marrow reserve is appropriate for this study
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-70.0, Multiple Myeloma Patients with multiple myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class I serologic match and class II molecular matched unrelated donor) Zubrod Points Scale (PS) < 2, life expectancy is not severely limited by concomitant illness Patient willing and able to sign informed consent Patients less than 70 years of age Active Central Nervous System (CNS) disease Uncontrolled acute or chronic Graft-versus-host disease (GVHD)
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Acute Promyelocytic Leukemia ECOG ≤ 3 Patients in first or subsequent hematological or molecular relapse of APL Persistence of a positive PCR (positive PCR after 3 consolidation cycles of first line therapy) Diagnostic measures Confirmation of relapse by RT-PCR of PML/RARa, cytogenetics, FISH or positive PGM3 Age over 18 years (No upper age limit) Informed consent of the patient ECOG 4 Heart failure NYHA grade III and IV Renal or hepatic failure WHO grade ³III Positive HIV Psychological dysfunction Associated active neoplasia Pregnancy Arsenic Hypersensibility QTc-interval prolonged over 460 msec before therapy (normal electrolytes, no other drugs prolonging the QT-interval )
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Male or female 18 years of age or older Not a candidate for high-dose chemotherapy and stem cell transplantation (HDT/SCT) due to age, presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT-SCT, or subject preference A Karnofsky Performance Status score of ≥50% Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage Asymptomatic multiple myeloma-related organ or tissue damage can presence of an asymptomatic lytic bone lesion or plasmacytoma, the presence of anemia (hemoglobin <10 g/dL), renal function impairment (serum creatinine > upper limit of normal [ULN]) or hypercalcemia (serum calcium >ULN) Must have measurable disease requiring systemic therapy. Measurable disease is defined by at least 1 of the following Quantifiable serum M-protein value (>1 g/dL of immunoglobulin (Ig)G or IgM M-protein, >0.5g/dL of IgA M-protein, >0.5 g/dL of IgD M-protein) Urine light-chain excretion ≥200 mg/24 hours Voluntary written informed consent must be given before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS). Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of lytic bone lesions. MGUS is defined by presence of serum monoclonal protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less Diagnosis of Waldenström's disease or other conditions in which immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration or lytic bone lesions Previously or currently treated with any systemic therapy for multiple myeloma. Prior treatment of hypercalcemia or spinal cord compression with corticosteroids or radiation therapy, respectively, does not disqualify the subject (the dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in 2-week period) Radiation therapy within 2 weeks before randomization. Enrollment of patients who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery) History of allergy to any of the study medications, their analogues, or excipients in the various formulations ≥Grade 2 peripheral neuropathy on clinical examination within 21 days before enrollment Any of the following clinical laboratory values within 21 days prior to enrollment Absolute neutrophil count (ANC) <1000 cells/mm^3 Platelets <100,000 × 10^9/L, or <70 × 10^9/L if thrombocytopenia is considered by the investigator to be due to myeloma infiltration of bone marrow
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma First relapse after ASCT Symptomatic myeloma More than 2,0 x 10^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support Signed informed consent given prior to any study related activities have been performed Age > 18 years Allogeneic transplantation scheduled as a part of the treatment Expected survival of less than one month Performance status (WHO) > 3 Neuropathy > Grade 3 (neurological symptoms interfering with ADL) Non-secreting myeloma Other concurrent disease making bortezomib treatment unsuitable Positive pregnancy test (only applicable for women with childbearing potential) Has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] <= 100 mmHg and/or sitting diastolic blood pressure [DBP] <= 60 mmHg)
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Previously diagnosed with multiple myeloma; Durie-Salmon Stage I, II, or III based on standard Progressive disease, defined as 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 gram/dL serum M-protein or at least 200 mg/24 hours of urine light chain excretion). For non-secretory multiple myeloma, progressive disease is defined as bone marrow biopsy with >25% increase in plasma cells or an absolute increase of at least 10% over prior known level. Alternatively, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia or relapse from CR year or older and willing and able to comply with the protocol requirements Patient has signed informed consent Unless a female patient is post-menopausal or surgically sterilized, must be willing to use an acceptable method of birth control (hormonal contraceptive, intrauterine device, diaphragm, with spermicide, condom with spermicide, or abstinence) for the duration of the study Male patient must agree to use an acceptable method for contraception for the duration of the study ECOG performance Status of < or equal to 2 Life expectancy is at least 3 months Initial Required Laboratory Values within 14 days of baseline i.e. Cycle 1, Day 1 (note that renal insufficiency, including dialysis dependence is permissable) ANC>1,000uL without the use of colony stimulating factors Pregnant or breast-feeding History of allergic reaction to compounds containing boron or mannitol Active uncontrolled viral (including HIV), bacterial, or fungal infection Grade III or IV toxicity due to previous anti-neoplastic therapy (except alopecia) Grade > or equal to 2 motor or sensory neuropathy as defined by the NCI Common Toxicity (NCI CTC) Grade 2: Either mild objective weakness or objective sensory loss/parasthesia (including tingling) that interferes with function, but not interfering with ADLs Grade 3: Objective weakness or sensory loss/parasthesia interfering with ADLs Grade 4: Paralysis or permanent sensory loss that interferes with function Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia For any patients whose lifetime cumulative doxorubicin dose exceeds 400 mg/m(2), patients with LVEF < or equal to 35% by MUGA are excluded. In other patients, MUGA is not required but if performed, LVEF must be > or equal to 35%
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma Male or female between ≥18 and ≤70 years Patient is a candidate for HDT combined with an autologous SCT Karnofsky Performance Status score of ≥60% Multiple myeloma diagnosed according to the following standard AND requiring systemic therapy Presence of M-component in serum and/or urine, plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma PLUS 1 or more of the following: 1. Calcium elevation (>11.5 mg/dL or >2.65 mmol/L) 2. Renal insufficiency (creatinine >2 mg/dL or >177 umol/L) 3. Anemia (hemoglobin <10 g/dL [<12.5 mmol/L] or at least 2 mg/dL [1.25 mmol/L] below normal) 4. Bone disease (lytic lesions or osteopenia) AND fulfill for measurable disease, as defined by at least 1 of the following 3 measurements: 1. Serum M-protein ≥1 g/dL (≥10 g/L) 2. Urine M-protein ≥200 mg/24 h 3. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal Women of childbearing potential must agree to use 2 methods of contraception Males must agree to use barrier contraception Subjects (or their legally acceptable representatives) must have signed an informed consent document Diagnosis of smoldering OR non-secretory multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS) Diagnosis of Waldenström's disease or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Prior or current systemic therapy for multiple myeloma including steroids Radiation therapy and/or plasmapheresis within 15 days before randomization History of allergic reaction attributable to compounds being given (VELCADE, thalidomide, dexamethasone, and/or cyclophosphamide) or compounds containing boron or mannitol Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 3.0 Uncontrolled or severe cardiovascular disease Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study Use of any investigational drugs within 30 days before randomization Pregnant or lactating women: A serum β-hCG pregnancy test must be performed at the Screening visit for female subjects of childbearing potential
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 4.0-999.0, Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Nasal Type Extranodal NK/T-cell Lymphoma Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission Childhood Burkitt Lymphoma Childhood Diffuse Large Cell Lymphoma Childhood Immunoblastic Large Cell Lymphoma Childhood Nasal Type Extranodal NK/T-cell Lymphoma Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET) Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Peripheral T-cell Lymphoma Plasma Cell Neoplasm Primary Systemic Amyloidosis Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Malignant Testicular Germ Cell Tumor Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Neuroblastoma Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Multiple Myeloma Regional Neuroblastoma Splenic Marginal Zone Lymphoma Testicular Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Waldenström Macroglobulinemia Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy Recurrent or refractory disease or disease at high risk for recurrence Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy Amyloidosis: primary or previously treated Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Subject must voluntarily sign and understand written informed consent Age > 18 years at the time of signing the consent form Histologically confirmed Salmon-Durie stage II or III MM. Stage I MM patients will be eligible if they display poor prognostic factors (ß2M ≥5.5 mg/L, plasma cell proliferation index ≥5%, albumin of less then 3.0, and unfavorable cytogenetics) Relapsed or refractory myeloma as defined by Appendix II, table 1, progression of disease either after prior therapy or lack of response to currently used therapy Prior treatment with prior lenalidomide and thalidomide as single agents or in combination with dexamethasone, but not in combination with each other No anti-myeloma therapy within 14 days prior to initiation of study treatment. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma All study participants must be registered into the mandatory RevAssist® and S.T.E.P.S.® programs, and be willing and able to comply with the requirements of the RevAssist® and S.T.E.P.S.® programs Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years Myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities Pregnant or lactating females are ineligible Given the potential of the study drugs to trigger or worsen HIV viremia and the incidence of opportunistic infections inpatients infected with the HIV virus, HIV-1 or HIV-2 positive patients will be excluded. The interactions of HAART with study drugs have not been determined Active hepatitis B or hepatitis C infection Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial Known hypersensitivity to dexamethasone, lenalidomide, or thalidomide History of thromboembolic event within the past 6 months prior to enrollment
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, End Stage Renal Disease adult >= 18 years of age end stage renal disease, undergoing concurrent dialysis treatment poorly controlled blood pressure on at least 2 antihypertensive drugs agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits competent and willing to provide written, informed consent to participate in this clinical study renal arterial abnormalities myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months hemodynamically significant valvular heart disease implantable cardioverter defibrillator (ICD) or pacemaker respiratory support pregnant, nursing or planning to be pregnant other
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, End-stage Renal Disease Primary renal transplant recipient for end-stage renal disease Recipient age < 18 years or > 65 years Previous history of CMV disease Hepatitis B and C recipients Primary disease states that require steroids for immunosuppression Re-transplant with immunological cause of renal or pancreas loss Non heart beating donors Recipient of pediatric en bloc kidneys Recipient with a Panel Reactive Antibody (PRA) score >75% Patients who have received 3 or more prior transplants, excluding pancreas Patients who are past recipients of other solid organ transplants
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-120.0, Multiple Myeloma and Plasma Cell Neoplasm Symptomatic multiple myeloma Previously treated disease meeting one of the following Have light-chain amyloidosis that has been treated with at least one prior regimen Symptomatic (relapsed or refractory) multiple myeloma Patients must have received 1-3 treatment regimens Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen Measurable disease, as defined by 1 of the following Serum monoclonal protein ≥ 1.0 g by protein electrophoresis More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis Serum immunoglobulin free light chain (FLC) > 10 mg/dL and an abnormal FLC ratio
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-69.0, Multiple Myeloma Less 70 years ECOG 0-2 Symptomatic MM (pain, anemia, infection, haemorrhage, loss of weight, hypercalcemia, extramedulary plasmocytoma, creatinine >2 mg/dl) No previous chemotherapy >70 years ECOG 3-4 myeloma quiescent cardiopathy liver disfunction HIV+ Hepatitis B-C + Previous chemotherapy
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Key Confirmed diagnosis of multiple myeloma with measurable disease Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma Eastern Cooperative Oncology Group Performance Status of 0 Last treatment for multiple myeloma not within 21 days prior to study treatment initiation Bone marrow transplant not within 3 months prior to study treatment initiation Required baseline hematology and chemistry parameters. Key Clinically significant cardiac disease (New York Heart Association Class III or IV) Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (>450 msec) after electrolytes have been corrected on baseline electrocardiogram Malabsorption syndrome or uncontrolled gastrointestinal toxicities Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation Clinically significant pleural effusion in the previous 12 months or current ascites Clinically significant coagulation or platelet function disorder Intolerance to dasatinib and/or bortezomib Acute diffuse infiltrative pulmonary disease Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Histochemical diagnosis of AL amyloidosis based on detection of green birefringent material in Congo red-stained tissue specimens by polarizing microscopy Measurable disease, as defined by one of the following Serum monoclonal protein ≥ 1.0 g by serum electrophoresis Urine monoclonal protein > 200 mg by 24-hour urine electrophoresis Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio Symptomatic organ involvement with amyloid to justify therapy May liver involvement, cardiac involvement, renal involvement, grade 1 peripheral neuropathy, or soft tissue involvement Must have more than skin purpura or carpal tunnel syndrome No amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as only evidence of disease Vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 9.0-999.0, Cicatrix, Hypertrophic Keloid patients with high grade microtia requiring a reconstruction with autologous rib cartilage diabetes mellitus vascular disease known allergic reaction to silicone
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of multiple myeloma Newly diagnosed disease Durie-Salmon stage II or III disease Measurable disease, defined by any of the following Measurable serum and/or urine M-protein levels documented and available prior to induction therapy Positive serum free light chain assay Must have completed a minimum of 3 courses of myeloma specific therapy Candidate for autologous stem cell transplantation Patients who have achieved a complete remission at the time of bone marrow harvest for marrow infiltrating lymphocytes (MILs) expansion are not eligible No evidence of spinal cord compression
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patients previously diagnosed with MM based on from the International Myeloma Working Group (IMWG) Patients who have 'measurable' disease Age 18 years at the time of signing Informed Consent A patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed on the current regimen and the other are met Patient is t(4;14) positive on screening assay Concomitant therapy medications that corticosteroids (> 10 mg per day of prednisone or equivalent) or other therapy that is or may be active against myeloma prior to day 1 (with the exception of radiation therapy or induction therapy as described under the above section Peripheral neuropathy of Grade 2 or greater Patients with evidence of mucosal or internal bleeding and/or refractoriness to platelet transfusions (i.e., unable to maintain a platelet count 50 x 109 /L) Patients with an absolute neutrophil count (ANC) < 1.0 x 109/L. Treatment to raise the ANC, such as granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) is not allowed within 14 days of study entry Patients with hemoglobin < 80 g/L despite transfusion Pregnant or lactating women
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma History of histologically documented MM with relapsed or progressive disease after either scheduled tandem or one autologous transplantation Patient has measurable disease in which to capture response Performance status of 2 as per Zubroid scale, unless PS of 3-4 based solely on bone pain Patients must have a platelet count 75,000/μL, and an ANC of at least 1,000/μL Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dL Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method Male or female adults of at least 18 years of age Patients must have signed an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations Chemotherapy or radiotherapy received within the previous 2 weeks Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity (See Appendix) Platelet count < 75,000/mm3, or ANC < 1,000/μl Clinically significant hepatic dysfunction as noted by bilirubin or AST > 3 times the upper normal limit or clinically significant concurrent hepatitis New York Hospital Association (NYHA) Class III or Class IV heart failure Myocardial infarction within the last 6 months Uncontrolled, active infection requiring IV antibiotics Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Previously untreated patients with the diagnosis of multiple myeloma are eligible. Similarly, patients who have not had more than one cycle of standard chemotherapy or up to one month of interferon and/or glucocorticoids are eligible Patients must have objective evidence of, or be symptomatic from, complications due to myeloma (e.g., bone pain from fractures, weakness from anemia). Asymptomatic patients may be treated only if the diagnosis is confirmed and if there is evidence of increasing tumor mass (e.g., rising myeloma protein and/or increasing lytic lesions) Asymptomatic patients with idiopathic monoclonal peaks, localized plasmacytomas, or indolent, asymptomatic myeloma are not eligible for this study. Any patient without documented increasing disease and/or clearly symptomatic disease is not eligible Measurable, direct manifestations of myeloma must be present, such as monoclonal serum or urine globulins. Plasma cell tumors must also be documented. Patients without protein are eligible if bone marrow has > 30% plasmacytosis documented by bilateral bone marrow aspirations and biopsies Patients with all stages of multiple myeloma (I, II, III) are eligible. Necessary baseline studies must be obtained to determine the stage prior to registration Patients may have received local radiation to painful compression fractures or lytic bone lesions, provided that adequate autologous bone marrow can still be harvested. Patients presenting with clinical conditions requiring radiotherapy (e.g. spinal cord compression) may proceed with concurrent local radiation and VAD. Should compression fractures of known prestudy lytic lesions occur during later, more myelosuppressive phases of induction therapy, radiotherapy should be completed first prior to proceeding with high-dose cyclophosphamide, EDAP or melphalan Patients should be older than 15 years of age and may be up to 65 years old Pregnant females are excluded from study change with the progress through the different phases of the induction program towards the two cycles of marrow-ablative therapy. These are summarized in the checklist Briefly, prior to VAD, patients must have a normal cardiac ejection fraction of > 50% (on ECHO cardiography or MUGGA scan), and fairly normal liver function tests (bilirubin < 2 mg% and serum transaminase levels less than 2 x normal). Screening for viral hepatitis should be negative for acute or chronic active hepatitis. Positive antibody (anti-HAV, HBSAb) suggestive of remote exposure is acceptable. However, patients who test positive for Hepatitis C antibody (anti-HCV) or HIV are ineligible. Those with renal failure are eligible and should start VAD promptly and receive additional medical measures as needed. Patients presenting with infections upon presentation shall receive proper medical management prior to starting therapy. Patient's performance status is not a criterion for entry on the VAD portion of this program Less than 10 x 108 cells/kg stored a granulocyte count of less than 1500/µl and a platelet count less than 150,000/µl
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma All patients must receive multi-agent based chemotherapy, preferably VAD, as cytoreduction prior to transplantation. The time from the last chemotherapy administration must be greater than 21 days. Patients with recurrent myeloma must have sensitive disease as demonstrated by a decrease in serum or urine paraprotein levels of >50% or a decrease in bone marrow plasmacytosis to less than 20%. Patients with newly diagnosed myeloma may have stable (but not progressive) disease following VAD Patients must have their pathology reviewed and the diagnosis of multiple myeloma confirmed at the transplant center. Patients with smoldering multiple myeloma or benign monoclonal gammopathy of unknown significance will be excluded from this study Performance status: -CALGB 0.1 or Karnofsky greater than 70% Patients must have serum creatinine < 2 x upper limit of normal, bilirubin < 2 x upper limit of normal, transaminases < 2 x upper limit of normal, MUGA resting EF > 50% or more than a 5% increase with exercise if <50%, DLCO > 60% Patients who have undergone bone marrow transplantation previously will not be eligible Patients with HIV, HBsAG positive Pregnant or lactating women Patients with other medical or psychiatric disorders which would seriously compromise tolerance to this protocol
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease) Relapsed or refractory disease At least two prior treatment regimens ECOG performance status 0-2 Adequate hepatic/renal function and platelet count If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50% Prior allogeneic bone marrow transplant, including syngeneic transplant Known intracranial disease or epidural disease Prior malignancy (within the last 3 years) Clinically significant cardiovascular disease or condition Active or chronically recurrent bleeding (eg, active peptic ulcer disease Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN Clinically relevant active infection Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease Symptomatic hyperviscosity syndrome Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior to study
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Myeloma, Plasma-Cell Lymphoma, Malignant Patients with multiple myeloma and lymphoma deemed by the treating institution to be candidates for high dose chemotherapy and autologous hematopoietic stem cell transplant. 2. Both males and females are eligible. 3. Patients should be 18 years old; multiple myeloma patients up to age 75 and lymphoma patients up to age 65 are eligible. 4. Patients with Karnofsky performance status of 60% or better. 5. Patients should have at least 2.5 x 106 cyropreserved CD34+ cells per kilogram available for transplantation. 6. Patients with adequate bone marrow function as defined as ANC ≥1000 cells/mm3 , platelet ≥ 75,000 cells/mm3. 7. Lymphoma patient must have adequate renal function as defined by a calculated creatinine clearance of 50% measured in ml/min. 8. The for renal function does not apply for multiple myeloma patients. Multiple myeloma patients undergoing hemodialysis are eligible. 9. All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater or equal to 48% within 42 days prior to registration. 10. Patients must have adequate pulmonary function as defined by room air pulse oximetry equal to or greater than 93%, and pulmonary function tests (FEV1 and DLCO) equal to or greater than 50% of predicted values. 11. Patients with adequate hepatic function as defined by serum bilirubin lower than 2.5 mg/dL and liver function tests to not exceed greater than 1.5x of the institutions ULN. 12. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with the institutional and federal guidelines. 13. Patients must be able to complete the anti-emesis assessment questionnaire. A Spanish questionnaire will be available for Hispanic-speaking patients Patients with nausea and have emetic episodes, and are receiving any anti-emetic medication taken within 24 hours of receiving antibiotics. 2. Active infection involving intravenous antibiotics. 3. Patients with known active hepatitis B and/or hepatitis C infections are excluded. 4. Patients with known HIV infection. 5. Primary or secondary brain neoplasms with increased intracranial pressure. 6. Received intrathecal chemotherapy within 24 hours of first dose of conditioning chemotherapy. 7. Patients who are nursing mothers or pregnant. Females of childbearing age are required to have a negative serum B-HCG pregnancy test 24 hours prior to enrollment on the study. 8. Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years. 9. Patients with uncontrolled medical problems such as diabetes mellitus, cardiac (i.e. congestive heart failure, coronary heart disease, arrhythmias), pulmonary hepatic and renal disease unless renal insufficiency is felt to be secondary to multiple myeloma, 10. Myocardial infarction within 6 months of enrollment in the study. 11. Major surgery within 4 weeks of enrollment. 12. Morbid obesity (BMI>40) 13. Patients with psychiatric or central nervous systems disorders interfering with ability to comply with study protocol. 14. Patients receiving therapeutic anticoagulant therapy for venous thromboembolic episode or other hypercoaguable states. Coumadin at 1 mg as prophylaxis for central venous catheter is allowed. 15. Known hypersensitivity to 5-HT3 antagonists and Aprepitant and their components. 16. Use of non-prescription and herbal-type medications within 72 hours of enrollment on the study. Their use are not allowed during the study. Multivitamins, nutritional supplements such as Boost, and other electrolyte replacements are allowed
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Mucositis Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of multiple myeloma Receiving treatment with high-dose melphalan for an autologous stem cell transplantation at any of these facilities Vanderbilt University Medical Center Nashville Veteran's Administration Medical Center (VAMC) Seattle VAMC San Antonio VAMC Not pregnant PRIOR See Disease Characteristics No palifermin
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Treatment demanding multiple myeloma Refractoriness to melphalan Acceptance of rules for prevention of pregnancy Previous treatment with bortezomib, thalidomide, or lenalidomide Sensory neuropathy grade III or neuropathic pain grade II Severe concomitant disorder, e.g. other malignancy or severe heart disease Transformation to plasma cell leukemia or aggressive lymphoma Frequent visits for bortezomib injections not feasible Anticipated non-adherence to study protocol Pregnancy Anticipated non-adherence to rules for prevention of pregnancy Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Plasma Cell Myeloma Patients must have a confirmed diagnosis of symptomatic myeloma; for the original diagnosis of myeloma patients should have met the following at one point in their disease course Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma Patient must have had symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis namely; at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction NOTE: Patients with asymptomatic smoldering myeloma (serum m protein >= 3 gm/dL or bone marrow plasma cells >= 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein < 3 gm/dL and bone marrow plasma cells < 10% plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible Patients must be > 65 and have declined alternative treatment OR patients who are >= 18 < 65 are eligible if they Are not a candidate for autologous stem cell transplantation in the opinion of the treating physician OR Have declined transplant or other alternative treatment Eastern Cooperative Oncology Group (ECOG) performance status =< 2 All tests below must be performed within 28 days prior to randomization Serum free light chain assay
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma Plasma Cell Leukemia Biologic high risk Multiple Myeloma Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics Relapsed or persistent multiple myeloma after ASCT Persistent multiple myeloma, regardless of previous therapies Plasma cell leukemia, regardless of previous therapies Age up to 70 years old (less than 71 years old at the date of transplant admission) Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission Patients with non-secretory and oligosecretory disease are eligible if they meet certain within 2 weeks prior to the transplant Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission) Persistent invasive infections, not controlled by antimicrobials HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity Uncontrolled medical or psychiatric disorder No response or progressive disease at the time of transplantation Pregnancy
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Understand and voluntarily sign an informed consent form Able to adhere to the study visit schedule and other protocol requirements Multiple myeloma, having undergone an allogeneic stem cell transplant from a matched or mismatched related or unrelated donor and have relapsed or have disease progression Relapse is defined as reappearance of monoclonal protein in serum or urine by immunofixation, new or increased bone lesions or hypercalcemia Disease progression is define as a 25% increase in monoclonal protein in serum or a 50% increase in 24 hour urinary monoclonal protein from the lowest level attained at any time point after allogeneic transplant or new or increased bone lesions or hypercalcemia All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, excluding corticosteroids for GVHD Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry Absolute neutrophil count >= 1.5 x 10^9/L Platelet count >= 50 x 10^9/L Serum creatinine =< 2.0 mg/dL Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking lenalidomide) Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Use of any other experimental drug or therapy within 28 days of baseline Known hypersensitivity to thalidomide The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs Resistance to prior use of lenalidomide Concurrent use of other anti-cancer agents or treatments Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C Acute GVHD grades 3 or 4
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma patients newly diagnosed with multiple myeloma and at the same time eligible for high dose chemotherapy and autologous stem cell transplantation patients with multiple myeloma experiencing relapse after high dose chemotherapy and autologous stem cell transplantation for newly diagnosed patients: age or comorbidity preventing high dose chemotherapy and autologous stem cell transplantation for all patients: age below 18, physical or psychological incapability to give an informed consent
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 60.0-999.0, Multiple Myeloma Primary Amyloidosis Patients with multiple myeloma over the age of 60 in any of the following disease categories: a) Primary refractory disease b) Consolidation of a first partial or complete remission. OR 2. Patients with primary amyloidosis. 3. Zubrod PS of <2 or Karnofsky >/= 70. 4. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 5. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 40%. No symptomatic pulmonary disease. 6. Serum bilirubin </= 2 X upper limit of normal, serum glutamate pyruvate transaminase (SGPT) </= 4 X upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage. 7. HIV-negative. 8. Patient is not pregnant. 9. Patient or guardian able to sign informed consent. 10. Have greater than or equal to 10 x 10 e 6 CD34+ cells per kg of autologous stem cells cryopreserved for stem cell transplantation, procured with 5 or fewer apheresis collections Patients unable to perform MDASI assessments due to language or cultural barriers
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Sickle Cell Disease Male or female patients between 18 and 65 years of age 2. Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study. 3. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding. 4. Patients must be diagnosed with Sickle Cell Disease (SS phenotype) Patients with any prior organ transplant or multi-organ transplant recipients. 2. Patients with evidence of an active systemic infection requiring the continued use of antibiotics, evidence of an HIV infection, or the presence of a chronic active hepatitis B or C. 3. Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer) 4. Patients with active illegal drug use
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Must speak and understand English; 2. Must be diagnosed with MM and meet one of the following 1) have been treated for MM with steroids only, or have received no more than two cycles of induction chemotherapy for MM and are going to be treated with bortezomib or thalidomide for induction therapy; 2) have received induction therapy and have been approved (or are being approved) medically and financially to receive autologous hematopoietic stem cell transplantation (Auto-HSCT); 3) cross sectional study patients will be either with a current diagnosis of asymptomatic MM not receiving treatment; or at least 12 months from the MM diagnosis, had received induction therapy, with or without received autologous hematopoietic stem cell transplantation (Auto-HSCT) and follow-up treatments. This cohort for a cross sectional survey may the cases been enrolled, either completed or dropped from the same study. It may also patients who did not participate on the first phase of the protocol (longitudinal cohort). 3. Patients >= 18 years old Patients who do not understand the intent of the study, so cannot or will not give informed consent 2. Patients who are unable to use the Interactive Voice Response (IVR) system due to physical limitations (e.g., hearing impairment). 3. Induction therapy patients with a neuropathy score of 3 or greater on the NCI's Common Terminology (CTC version 3.0) either at the beginning of induction chemotherapy or after 1-2 cycles of chemotherapy as a result of previous treatment or from some other comorbid cause. This does apply to the auto-HSCT patients
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Lymphoma, Large Cell, Diffuse Aged from 18 to 65 years Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO classification) Diffuse large B cell lymphoma Adverse prognostic factors IPI>1 In Complete Remission, or partial response to first line treatment Previously treated with chemotherapy regimen containing rituximab: R CHOP or R ACVBP Chemo-sensitive disease PET Scan prior transplant Eligible for autologous stem cell transplantation With a minimum life expectancy of 3 months Histological transformation in diffuse large B cell lymphoma, any type of low grade lymphoma More than one line of treatment. Prior transplantation. Prior exposure to Zevalin Central nervous system or meningeal involvement by lymphoma Contraindication to any drug contained in the chemotherapy regimen Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the IDB) Poor renal function (creatinin level up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma Poor hepatic function (total bilirubin level up to 30 micro mol/l, transaminases up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma Poor bone marrow reserve as defined by neutrophils less than 1.5 G/l or platelets less than 100 G/l Large bone marrow irradiation more than 40percent Bone marrow infiltration
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Must understand and voluntarily sign informed consent form 2. Age ≥ 18 years at the time of signing consent 3. Previously untreated, symptomatic multiple myeloma as defined by the 3 below MM diagnostic (all 3 required) Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma Monoclonal protein present in the serum and/or urine Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease by protein electrophoresis analyses as defined by the following IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because Previous treatment with anti-myeloma therapy (does not radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]). 2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment. 3. Pregnant or lactating females. 4. Any of the following laboratory abnormalities Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L) Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L) Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) 5. Renal failure requiring hemodialysis or peritoneal dialysis. 6. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions the following Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) 7. Patients who are unable or unwilling to undergo antithrombotic therapy. 8. Peripheral neuropathy of > grade 2 severity. 9. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Understand and voluntarily sign an informed consent form. 2. Age 18 years or older at the time of signing the consent. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Multiple myeloma (MM) diagnosed according to the following standard Monoclonal plasma cells in bone marrow ≥10% and/or presence of biopsy-proven plasmacytoma Monoclonal protein present in serum and/or urine Myeloma-related organ dysfunction (1 or more) (C) Calcium elevation in blood (serum calcium >10.5 mg/L or ULN) (R) Renal insufficiency (SCr >2 mg/dL) (A) Anemia (hemoglobin <10 g/dL or 2g <normal) (B) Lytic bone lesions or osteoporosis 5. Measurable disease requiring systemic therapy. 6. High risk multiple myeloma defined by the presence of one or more of the following Deletion of chromosome 13 by metaphase analysis (standard cytogenetics) deletion of 17p13 (p53) by Fluorescence in situ hybridization (FISH) or metaphase analysis t(4;14) by FISH t(14;16) by FISH t(8;14) by FISH t(14;20) by FISH hypodiploidy detected by FISH or metaphase analysis Any serious medical condition, laboratory abnormality, or psychiatric illness to prevent the subject from signing the consent. 2. Pregnant or breast feeding females. 3. Any condition which places the subject at unacceptable risk or confounds the ability to interpret data from the study. 4. Abnormal laboratory test results within these ranges Absolute neutrophil count < 1.0 x 109/L Platelet count < 50 x 109/L (Subjects with severe pancytopenia (not meeting the above criteria) due to myeloma involvement of > 70% bone marrow are eligible) Serum creatinine > 2.5 mg/dL or ≥ 3.0 mg/dL if due to multiple myeloma Total bilirubin > 2.0 mg/dl 5. History of allergy to any of the study medications, their analogues, or excipients in the various formulations 6. Concurrent use of other anti-cancer agents or treatments. 7. Known HIV positivity 8. Known Active Hepatitis A, B or C 9. Erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drug
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Confirmed diagnosis of Multiple Myeloma Received prior courses of bortezomib (VELCADE)-based therapy Greater than or equal to 50% reduction in M-Protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of therapy days or more since the patient's last dose Life expectancy > 3 months Progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a >25% increase in M-protein No patients with progressive disease while receiving an anthracycline-based regimen No patients with >2 prior regimens for the treatment of multiple myeloma No major surgery within 2 weeks before screening No patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent No patients known to be human immunodeficiency virus (HIV) positive No patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness No patients with an active systemic infection requiring treatment
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-999.0, End-Stage Renal Disease Prosthetic Arteriovenous Access end-stage renal disease underwent the specific prosthetic arteriovenous access creation in our hospital from November 2003 to October 2005 patients' poor health as long as they did not have other options and needed an access for acute hemodialysis. Exclusions included shock, active systemic infection, and rejection by the attending nephrologists
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-71.0, Autoimmune Disease Neurologic Autoimmune Disease Autologous Transplant Autoimmune Multiple Sclerosis Transplant MS Stem Cell Transplant Multiple Sclerosis Stem Cell Transplant Stiff Person Syndrome HCT for Neurologic Autoimmune Disorders CIDP Transplant Myasthenia Gravis Transplant Autoimmune Nervous System Disorder Central Nervous System Vasculitis Cerebellar Degeneration Chronic Inflammatory Demyelinating Polyneuropathy Lambert Eaton Myasthenic Syndrome Myasthenia Gravis Neuromyelitis Optica Opsoclonus Myoclonus Syndrome Rasmussen Subacute Encephalitis Patients with an autoimmune disorder of the central or peripheral nervous system will be eligible; this will Primary Central Nervous System (CNS) vasculitis Rasmussen's encephalitis Autoimmune peripheral neuropathy (anti-Hu [Anna-1], anti-GM1 [GD1b], anti-MAG, anti-ganglioside, anti-sulfatide) Autoimmune cerebellar degeneration Gait Ataxia with Late age Onset Polyneuropathy (GALOP) Stiff Person Syndrome Chronic Inflammatory Demyelinating Polyneuropathy Myasthenia Gravis Lambert-Eaton myasthenic syndrome Pregnancy or expressed plans to become pregnant within 1 year of the procedure Patients who are serologically positive for human immunodeficiency virus (HIV) Patients with pulmonary, cardiac, hepatic or renal impairment that would limit their ability to receive cytoreductive therapy and compromise their survival; this should patients with any of the following Severe pulmonary dysfunction associated with a carbon monoxide diffusing capacity (DLCO) (corrected for hemoglobin) < 60%, or requires supplemental oxygen; patients who are unable to perform pulmonary function test (because of underlying disease) will be excluded if the oxygen saturation is < 92% on room air Uncontrolled malignant arrhythmias, or clinical evidence of congestive heart failure (New York class III-IV) or ejection fraction < 50% Renal disease with estimated glomerular filtration rate (GFR) by creatinine clearance or iothalamate clearance < 50 ml/min/1.73 m^2 body surface area Serum glutamate pyruvate transaminase (SGPT)/aspartate aminotransferase (AST) > 3 times normal or direct bilirubin greater than 2.5 mg/dL on two repeated tests Active uncontrolled infection Demonstrated lack of compliance with prior medical care Patients whose life expectancy is limited by illness other than their neurological condition
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease) Relapsed or refractory disease ECOG performance status 0-2 Adequate hepatic/renal function and platelet count If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50% Fully recovered from any previous cancer treatments and/or major surgery Prior allogeneic bone marrow transplant, including syngeneic transplant Bone marrow transplant within 12 weeks prior to study Known intracranial disease or epidural disease Inability to tolerate Velcade Inability to tolerate Decadron Prior malignancy (within the last 3 years) Clinically significant cardiovascular disease or condition Active or chronically recurrent bleeding (eg, active peptic ulcer disease Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN Clinically relevant active infection
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma stage I multiple myeloma without bones injuries abnormal kidney function VIH infection Hepatic incapacity pregnancy Associate pathology
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-999.0, Multiple Myeloma Autologous Transplantation All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662)
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-60.0, Multiple Myeloma Multiple Myeloma Stage II or III acc. to Salmon and Durie Patient's age 18-60 years Patient's written informed consent Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD) More than eight chemotherapy cycles prior to registration severe irreversible renal, hepatic, pulmonary or cardiac disease, such as total bilirubin, SGPT or SGOT > 3 times upper the normal level Left ventricular ejection fraction < 30 % Creatinine Clearance < 30 ml/min DLCO < 35 % and/or receiving supplementary continuous oxygen Positive serology for HIV Pregnant or lactating women Participation in another trial at the time of registration Preceding autologous stem cell transplantation
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Impaired Renal Function Documented diagnosis of relapsed or refractory multiple myeloma (MM) Age > 18 years at the time of signing the informed consent form Stable renal function Documented amyloidosis Any prior use of Revlimid ® Any contraindication to Revlimid ® and especially Lack of acceptable method of birth control for female of childbearing potential (FCPB) Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB Pregnant or breast feeding women
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-66.0, Multiple Myeloma Stem Cell Transplantation Multiple Myeloma Stadium II / III acc. to Salmon and Durie signed informed consent adequate organ function prior autologous respectively allogeneic SCT availability of HLA-identical related or unrelated donor availability of at least 2 x 10^6 CD34+ cells per kg BW of recipient for the autologous SCT and at least 3 x 10^6 CD34+ cells for allogeneic SCT for MRD-SCT: 18-66 years; for MUD-SCT: 18-55 years at age <55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky consent of donor to give DLI severe heart insufficiency cardiovascular diseases or severe concomitant diseases active infections that need antibiotic therapy positive for HIV or hepatitis malign secondary disease limited liver function with total bilirubin > 1.5 ULN increased transaminase > 3 ULN increased serum creatinine > 2 mg/dl pregnant or lactating women known hypersensitivity to Fludarabine or Melphalan
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma Histologically confirmed primary systemic amyloidosis based on the following Amyloid light-chain disease Deposition of amyloid material by congo red stain showing characteristic green birefringence Monoclonal light chain protein (Bence Jones protein) in the serum or urine, immunohistochemical studies, or serum free light chain assay Evidence of tissue involvement other than carpal tunnel syndrome (i.e., positive immunohistochemical staining of bone marrow demonstrating clonal plasma cells); tissue amyloid deposits with anti-kappa or anti-lambda anti-serum; evidence for a plasma cell dyscrasia by serum/urine or bone marrow; or overwhelmingly convincing clinical features (e.g., macroglossia) associated with other systemic manifestations Southwest Oncology Group performance status 0-1 Fertile patients must use effective contraception Left ventricular ejection fraction ≥ 45% by Echocardiogram within the past 60 days diffusion capacity of lung for carbon monoxide ≥ 50% PRIOR Prior chemotherapy with alkylating agent allowed provided there is no morphological or cytogenetic evidence of myelodysplastic syndromes No senile, secondary, localized, dialysis-related, or familial amyloidosis No overt multiple myeloma (> 30% of bone marrow plasmacytosis, extensive [> 2] lytic lesions, or hypercalcemia) Not pregnant or nursing No myocardial infarction within the past 6 months, congestive heart failure, or arrhythmia refractory to therapy No prior malignancy except for any of the following Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer currently in complete remission Any cancer from which the patient has been disease-free ≥ 5 years No advanced (grade 3-4) pre-existing neuropathy
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-70.0, Multiple Myeloma and Plasma Cell Neoplasm Neurotoxicity Multiple Myeloma patients with symptomatic disease, stage II or III at diagnosis or progressive stage I requiring chemotherapy and/or radiation therapy (by Salmon-Durie classification), who are not eligible for tandem transplant study using TMI; because of previous radiation or criteria; documentation of disease staging by both Salmon-Durie classification and International Staging System (ISS) is required Patients with non-secretory myeloma should have measurable serum free-light chain protein by the Free-lite test or measurable disease such as a soft tissue myeloma A minimum of 4 x 10^6 of CD 34 Positive cell/kg has been harvested A Karnofsky performance status (KPS) of >= 70% is required unless the KPS is impaired due to bone disease No contraindication to the collection of a minimum of 4 x 10^6 CD34+ cells/kg by apheresis All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines Bilirubin =< 1.5 mg/dl Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) < 2.5 x upper limits of normal Creatinine clearance of >= 40cc/min Absolute neutrophil count of > 1000/ul Presence of peripheral neuropathy >= grade II Patients with evidence of disease progression (with >= 25% increase in M protein) on bortezomib and or thalidomide therapy prior to transplant Pregnant or nursing women, as well as women of child bearing age, who are unwilling to use a dual method of contraception and men who are unwilling to use condom Patients with history of hypersensitivity to bortezomib, boron or mannitol
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Hyperparathyroidism Kidney Disease Age at or above 18 years End stage renal disease on regular maintenance haemodialysis or peritoneal dialysis for at least 3 months iPTH level of 300 pg/ml or greater at baseline Written informed consent by subject or guardian Female patients will either be post-menopausal for more than 2 years, surgically sterile or if of childbearing age, using double contraception Baseline calcium value more than 2.87 mmol/L Baseline Ca x P of greater than 5.63 mmol2/l2 Positive for HBsAg or Hepatitis C with raised ALT twice above upper limit of normal or evidence of liver cirrhosis Clinically significant gastrointestinal disease History of allergic reaction to calcitriol or other vitamin D compounds Inability or unwillingness to provide written consent Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator Pregnancy, breastfeeding or use of non-reliable method of contraception Use of medications prohibited prior to randomization such as ketoconazole and other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir Necessity for calcitonin, biphosphonates, maintenance oral or intravenous glucocorticoid or cinacalcet or other drugs that may affect calcium or bone metabolism
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Major 1. Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded. 2. Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents. 3. Age ≥18 years. 4. ECOG performance status 0-2. 5. Patients must have adequate organ and marrow function Major Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076. 2. Prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis). 3. Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions. 4. Have unstable angina pectoris or recent myocardial infarction (within 6 months. 5. Have uncontrolled hypertension or congestive heart failure
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 21.0-90.0, Primary Amyloidosis Confirmed diagnosis of AL amyloidosis New York Heart Association class IV patient on renal dialysis serum antibodies to mouse protein
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Newly Diagnosed multiple myeloma, ISS stage I-III requiring therapy: Serum M-protein ≥1 gm/dL (≥10 gm/L), Urine M-protein ≥200 mg/24 hr, Serum FLC assay: involved FLC ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal Previously untreated except prior treatment with corticosteroid less than one full cycle of pulsed dose dexamethasone (40 mg daily days 1-4, 9-12, and 17-20) or equivalent is allowed. Concomitant administration of IV bisphosphonates, Zometa (zoledronic acid, up to 4 mg IVSS over 30 minutes every four weeks) or Aredia (alendronate, up to 90 mg IVSS over 4 hours every four weeks), for prophylaxis against skeletal complications due to lytic bone disease or for acute management of hypercalcemia is allowed. Concomitant external beam radiation therapy for local management of lytic bone disease is allowed Age ≥ 18 years old Life expectancy ≥ 12 weeks Eastern Cooperative Oncology Group (ECOG) Performance Status will be employed. ECOG 0-2 accepted WBC ≥ 3.0 X 103/ µL, ANC ≥ 1.5 X 103/ µl, Hgb ≥ 8.0 gm/ dL, Plt ≥ 75 X 103/ µl, Serum Creatinine ≤ 2.0 mg/ dL Ability to understand and the willingness to sign a written informed consent document All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods Prior therapy with Revlimid®, Thalomid (thalidomide), Velcade (bortezomib), Alkeran (melphalan) excluded. Prior therapy with corticosteroid allowed as defined in criteria No prior or concurrent treatment with an investigational agent Active Hepatitis B or C excluded, New York Heart Association grade III/IV congestive heart failure excluded, History of bleeding disorder excluded, History of platelet function disorder, History of deep vein thrombosis or other thromboembolic event excluded Prior history of allergic reaction to IMiD™ compounds (Thalidomide, Lenalidomide) excluded Concomitant treatment with nonsteroidal antiinflammatory drugs (NSAIDs)(with the exception of aspirin) or other nephrotoxic agents is excluded Serum creatinine > 2.0 mg/ dL is excluded Pregnancy and breastfeeding excluded Known HIV+ patients are excluded Other active hematologic or solid tumor or history of such disease requiring therapy of any form within five years of screening is excluded
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma End Stage Renal Disease Recipient 1. Participants with end-stage renal failure due to or in association with greater than or equal to stage II multiple myeloma 2. Males or females 18 years of age. 3. Participants must have an HLA-matched or one of six HLA A, B, or DR antigen-mismatched related donor, with high resolution molecular DR allele determination. 4. Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 2 years following the transplant. 5. Participants should be on dialysis or have a CrCl <20 ml/min. 6. Participants must receive medical clearance by a cardiologist prior to conditioning for transplant. 7. Life expectancy greater than or equal to 6 months. 8. Recipient ability to understand and provide informed consent. Recipient Evidence of active infection as defined by: a) clinical syndrome consistent with viral or bacterial infection (e.g., influenza, URI, UTI) or b) fever with a clinical site of infection identified, or c) microbiologically documented infection, including, but not limited to, bacteremia or septicemia. 2. Participation in other investigational drug use at the time of enrollment. 3. Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to horse serum in ATG). 4. Serologic positivity to HIV, HCV, or HbsAg positivity. 5. Women of childbearing age in whom adequate contraception cannot be maintained. 6. Malignancy within the past two years other than multiple myeloma, excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix. 7. AST/ALT > 3 x normal or bilirubin > 1.5 x normal (unless due to Gilbert's syndrome). 8. Pregnancy or uncontrolled serious medical illness not related to underlying myeloma. 9. Cardiac ejection fraction < 40% by echocardiogram; individual assessment if ejection fraction between 40% and 50%. 10. FEV1 < 50% predicted or corrected DLCO < 50% predicted. 11. ABO blood group incompatibility in the host-vs-graft direction. Donor 1. HLA-matched or one of six HLA A, B, or DR antigen-mismatched related male or female donor 18-65 years of age. 2. ECOG performance status 0 or 1. 3. Excellent health per conventional pre-donor history (medical and psychosocial evaluation). 4. Acceptable laboratory parameters (hematology in normal or near-normal range; liver function < 2 times the upper limit of normal and normal creatinine). 5. Compatible ABO blood group. 6. Negative donor lymphocyte crossmatch. 7. No positive testing for viral infection (HbsAg, HIV, HCV, HTLV-1). 8. Cardiac/Pulmonary evaluation within normal limits (CXR, EKG). 9. Donor ability to understand and provide informed consent
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 3.0-75.0, Accelerated Phase Chronic Myelogenous Leukemia Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Aplastic Anemia Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission Childhood Chronic Myelogenous Leukemia Childhood Diffuse Large Cell Lymphoma Childhood Immunoblastic Large Cell Lymphoma Childhood Myelodysplastic Syndromes Childhood Nasal Type Extranodal NK/T-cell Lymphoma Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia de Novo Myelodysplastic Syndromes Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Fanconi Anemia Juvenile Myelomonocytic Leukemia Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Marginal Zone Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Paroxysmal Nocturnal Hemoglobinuria Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Splenic Marginal Zone Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Small Lymphocytic Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Small Lymphocytic Lymphoma Waldenström Macroglobulinemia Diagnosis of a histology documented hematologic malignancy or marrow disorder Bone marrow failure disorders and other non-malignant hematologic or immunologic disorders Acquired bone marrow failure disorders aplastic anemia, paroxysmal nocturnal hemoglobinuria (PNH) Primary allogeneic hematopoietic stem cell transplantation (HSCT) is appropriate for selected patients with severe aplastic anemia; however, patients with aplastic anemia must have failed at least one cycle of standard immunosuppressive therapy with calcineurin inhibitor plus anti-thymocyte globulin (ATG) if a fully-matched donor is not available Patients with PNH must have a history of thrombosis related to PNH Hereditary bone marrow failure disorders Fanconi anemia or related chromosomal breakage syndrome dyskeratosis congenita, Diamond-Blackfan anemia, Shwachman-Diamond syndrome, Kostmann syndrome, congenital amegakaryocytic thrombocytopenia Fanconi anemia or related chromosomal breakage syndrome: positive chromosome breakage analysis using diepoxybutane (DEB) or mitomycin C if applicable Dyskeratosis: diagnosis is supported by using either telomerase reverse transcriptase (TERC) gene mutation in autosomal dominant Dyskeratosis Congenita or Xlinked DKC1 gene mutation Other non-malignant hematologic or immunologic disorders that require transplantation Quantitative or qualitative congenital platelet disorders (including but not limited to congenital amegakaryocytopenia, absent-radii syndrome, Glanzmann's thrombasthenia) Uncontrolled central nervous system (CNS) disease (for hematologic malignancies) Karnofsky (adult) or Lansky (for =< 16 years) performance status =< 50% Diffusing capacity of the lung for carbon monoxide (DLCO) less than 40% predicted, corrected for hemoglobin (Hb) and/or alveolar ventilation Cardiac: left ventricular ejection fraction less than 40% Bilirubin >= 3 x upper limit of normal Liver alkaline phosphatase >= 3 x upper limit of normal Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) >= 3 x upper limit of normal Child's class B and C liver failure Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics Patients who have received maximally allowed doses (given in 2 Gy fractions, or equivalent) of previous radiation therapy to various organs as follows
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-60.0, Stem Cell Transplantation Leukemia Lymphoma Diagnosed with one of the following diseases: 2. Acute myelogenous leukemia (AML) in induction failure, relapse, past first remission, or CR1 considered at risk for relapse 3. Myelodysplastic syndromes with International Prognostic Scoring System score (IPSS score) >/= 2 or myelodysplasia that has not responded to chemotherapy 4. Biphenotypic leukemia 5. Acute lymphocytic leukemia with induction failure, first complete remission with high risk cytogenetics (e.g. Philadelphia positive chromosome, t(4:11) Remission requiring more than 2 chemotherapy to achieve remission, or any stage beyond CR1 6. Chronic Myelogenous Leukemia (CML): second chronic phase, accelerated phase or blast crises with less than 10% blasts in the bone marrow, or CR1 and resistance to Gleevec or other tyrosine kinase inhibitors 7. Non-Hodgkin's Lymphoma induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant) 8. Hodgkin's disease induction failure, second or later complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant). 9. Chronic Lymphocytic Leukemia that has failed induction therapy or Rai Stages 2-4 10. Related or unrelated donor which is HLA-matched or mismatched in 1 HLA A, B, C, DR, or DQ locus is acceptable (i.e. >/= 9/10 matched related or unrelated donor, matched with molecular high-resolution technique per current std. for BMT program). Cord blood units must match patient at 4, 5, or 6/6 HLA class 1 serological & II molecular antigens with a min. of 2 x 10e7 TNC/kg recipient weight in the pre-thawed fraction. For patient lacking a matched related or unrelated donor or acceptable cord blood unit(s), a related haploidentical donor (</= 7/8 allele matched at A, B, C, DR loci) may be used. 11. Age </= 60 years. 12. Lansky performance score >/= 50% for patients </= 16 years of age, or Zubrod performance status score of 0-2 for patients > 16 years of age. 13. Cardiac function left ventricular ejection fraction >/= 40%. 14. Pulmonary function diffusion capacity of at least 50% predicted. Children unable to perform pulmonary function tests (e.g. less than 7 years old) pulse oximetry of >/= 92% on room air. 15. Serum creatinine < 1.6 mg/dL or creatinine clearance >/= 50 ml/min. 16. SGPT </= 200 IU/mL, serum bilirubin < 1.5 x normal. 17. Written informed consent and assent as is age appropriate. 18. No active infection Pregnancy in women of child bearing potential (pregnancy test performed within 2 weeks of study entry). 2. HIV positive (highly immunosuppressive treatment) 3. Active CNS leukemia 4. Chronic or active Hepatitis B or Hepatitis C. If questions about liver health discuss with PI and strongly consider liver biopsy
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate Measurable serum and/or urinary paraprotein European Cooperative Oncology Group performance status 0-3 Serum bilirubin < 1.5x the upper limit of normal (ULN) Serum alanine transaminase (ALT)/aspartate transaminase values < 2.5 x ULN Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study Woman of child bearing potential Non-secretory MM Serum creatinine > 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-60.0, Acute Myeloid Leukemia (AML) Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) Bone marrow aspirate or biopsy must contain ≥ 20% blasts of all nucleated cells or differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of nonerythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations, the proportion of blasts may be < 20% Age ≥ 18 and ≤ 60 years Informed consent, personally signed and dated to participate in the study ECOG performance status of 0-1 Life expectancy of at least 12 weeks Adequate liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to Screening Patients who are not eligible for standard chemotherapy as per discretion of the treating physician Central nervous system manifestation of AML Cardiac disease: heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) Chronically impaired renal function (creatinine clearance < 30 ml/min) (Cockcroft-Gault formula) Patients undergoing renal dialysis Chronic pulmonary disease with relevant hypoxia Known HIV and/or hepatitis C infection Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-120.0, Multiple Myeloma and Plasma Cell Neoplasm Meets 1 of the following Diagnosed with multiple myeloma and treated with thalidomide or lenalidomide on clinical trial ECOG-E4A03 or E-E1A00 Healthy volunteer Not specified PRIOR See Disease Characteristics
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma Newly diagnosed symptomatic multiple myeloma (MM) patient Aged under 65 Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day) Using effective contraceptive methods (for fertile men, women of childbearing potential) Provision of informed consent No evidence of active infection Asymptomatic MM Non-secretory MM Aged 66 years or over ECOG performance status over 2 (see Appendix 2) Proven amyloidosis A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer) Positive HIV serology A personal medical history of severe psychiatric disease Severe diabetes contraindicating the use of high-dose dexamethasone NCI grade ³ 2 peripheral neuropathy
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for high dose chemotherapy with stem cell transplantation Eastern cooperative oncology group performance status score of less than or equal to 2 Measurable secretory disease, defined as either serum monoclonal paraprotein greater than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours Adequate laboratory results that will be confirmed by a study physician Agrees to protocol-defined use of effective contraception Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Received prior or current systemic therapy or stem cell transplantation for multiple myeloma Peripheral neuropathy or neuropathic pain (Grade 2 or higher) Received radiation therapy, plasmapheresis or surgery within 14 days Transplanted solid organ, with the exception of a corneal transplant Serious concurrent illness or history of uncontrolled heart disease
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-85.0, End-stage Renal Disease Patients with patients with end-stage renal disease (ESRD) who are suitable candidates for AVF creation (as assessed by pre-operative vein mapping) and plan to undergo AVF creation are eligible to participate Study subjects must agree to participate in the study and provide written informed consent Age: Study subjects must be > 18 years old Sites: Emory University affiliated hospitals (including Emory University Hospital, Emory Midtown Hospital, Grady Memorial Hospital) and Emory University affiliated outpatient dialysis units Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent Age < 18 years Patients with a corrected serum calcium > 10.5 mg/dL within 4 weeks of study screening Current intake of > 2000 IU per day of Vitamin D3 Subjects unable to provide informed consent or who plan to relocate outside of Atlanta during the study duration
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with multiple myeloma who have received induction therapy and have had stem cells mobilized in preparation for autologous transplantation will be eligible for this study. Patients are also eligible with relapsed or refractory disease, after attempts at more standard approaches, and with the availability of stem cells Patients must be age 18 or older Patients must have a life expectancy of at least 12 weeks Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Patients must provide written informed consent Impaired renal function with a measured or calculated creatinine clearance of less than 25 ml/min Impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 x ULN Serious active or uncontrolled infection or medical condition Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test Impaired pulmonary function with a diffusing capacity of the lung for carbon monoxide (DLCO) less than 45% predicted Impaired cardiac function with an ejection fraction less than 40% of predicted Other systemic anticancer therapy or ongoing toxicities from such therapy
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of multiple myeloma Candidate for high-dose chemotherapy and autologous stem cell transplantation No definite morphologic evidence of myelodysplasia on pretreatment bone marrow ECOG performance status (PS) 0-2 or Karnofsky PS 70-100% ANC > 500/mm^3 Platelet count ≥ 75,000/mm^3 Total bilirubin ≤ 2.0 mg/dL AST and ALT ≤ 3 times upper limit of normal Creatinine ≤ 2.0 mg/dL LVEF ≥ 45%
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Multiple Myeloma Criteria(International Uniform Response for Multiple Myeloma) Patients with responsive disease after any line of induction therapy A complete response A very good partial response A partial response Patients greater than or equal to 18 years of age are eligible. There is upper age limit of 60 years for allogeneic transplants Patients must have a histologically confirmed diagnosis All patients should have a life expectancy of at least 12 weeks Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance Meet the following for allogeneic hematopoietic cell transplant Patients who do not achieve at least a partial response (PR) by the mentioned above with induction therapy Patient has a platelet count of <30 x 10^9/L within 14 days before enrollment Patient has >/= Grade 2 peripheral neuropathy within 30 days before enrollment Patient has an absolute neutrophil count of <1.0 x 10^9/L within 30 days before enrollment Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant in order for the subject to be considered eligible. Left ventricular ejection fraction (LVEF) by multiple gated acquisition (MUGA) scan < 40% Patient has hypersensitivity to bortezomib, boron or mannitol Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women Patient has received other investigational drugs with 30 days before enrollment Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients with a diffusing capacity of lung for carbon monoxide (DLCO) less than 50% (adjusted) of normal or with symptomatic obstructive or restrictive lung disease are ineligible
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Peripheral Neuropathy Patients with multiple myeloma receiving bortezomib Patients not able to provide informed consent Patients with coagulation disturbances or immunocompromised patients
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patient is of a legally consenting age as defined by local regulations. 2. Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements. 3. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. 4. Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalidomide therapy. 5. Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalidomide therapy. 6. Patient was previously diagnosed with symptomatic multiple myeloma based on standard (12), and has measurable disease, defined as follows Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan). 7. Patient is relapsed or refractory after one or two lines of treatment 8. Patient has a Karnofsky performance status ≥ 60%. 9. Patient has a life-expectancy > 3 months. 10. Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1) Platelet count ³ 100 x 109/L without transfusion support within 7 days before the test Absolute neutrophil count ³ 1.0 x 109/L without the use of growth factors Total bilirubin £ 1.5 x the ULN AST (SGOT) and ALT (SGPT) £ 2.5 x ULN Corrected serum calcium < 14 mg/dl (3.5 mmol/L) Calculated or measured creatinine clearance: ≥ 20 mL/minute Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or beast feeding females. 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Use of any other concomitant standard/experimental anti-myeloma drug or therapy 5. Prior induction therapy with R-MP or M-PT association 6. Any of the following laboratory abnormalities Platelet count < 100 ´ 109/L Absolute neutrophil count <1.0 ´ 109/L Aspartate transaminase (AST): >2.5 x the upper limit of normal (ULN) Alanine transaminase (AST): > 2.5 x the ULN Total bilirubin: > 1.5 x the ULN Corrected serum calcium >14 mg/dL (3.5 mmol/L) Calculated or measured creatinine clearance <20 mL/minute 7. Known positive for HIV or active infectious hepatitis, type B or C. 8. Patient has ³Grade 2 peripheral neuropathy within 14 days before enrollment. 9. Known hypersensitivity to thalidomide
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-75.0, Multiple Myeloma Patients with multiple myeloma who have relapsed after an autologous transplant or with a chemosensitive relapse more than one year post initial therapy 2. Age 18 to 75 years 3. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias 4. FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease 5. Serum bilirubin </= 2 x upper limit of normal, SGPT </= 4 x upper limit of normal 6. HIV-negative 7. Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization 8. Patient or guardian able to sign informed consent 9. Marrow-MSC Donor Requirements: patients must have a family member who is matched at 2, 3, or 4 HLA antigens and willing to donate 80-100 ml or bone marrow for MSC generation International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin < 3.5 mg/L and albumin >/= 3.5 g/dL) 2. Patients with an apheresis collection </= 7 x 10e6 CD34+/Kg 3. A fully matched related donor
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-75.0, Lymphoma B-cell Lymphoma Patients with a history of CD19+ lymphoid malignancies that are beyond first remission or primary refractory to treatment. 2. Age 18 to 75 years. 3. Zubrod performance 0-1 or Karnofsky greater than or equal to 80%. 4. Patient able to provide written informed consent. 5. Patient able to provide written informed consent for the long-term follow-up gene therapy study. 6. at time of transplant conditioning regimen (criteria 6-13): Zubrod performance 0-1 or Karnofsky greater than or equal to 80%. 7. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease. 8. No symptomatic pulmonary disease. FEV1, FVC and DLCO >/= 50% of expected, corrected for hemoglobin. 9. Serum creatinine </= 1.8mg/dL or creatinine clearance >/= 40 cc/min. 10. Adequate hepatic function, as defined by SGPT <3 X upper limit of normal; serum bilirubin and alkaline phosphatase <2 X upper limit of normal, or considered not clinically significant. 11. If positive Hepatitis B and/or Hepatitis C serology, discuss with Principal Investigator or designee and consider liver biopsy. 12. No pleural/pericardial effusion or ascites estimated to be >1L. 13. Not breast feeding or pregnant. Pregnancy determined by a positive beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. 14. at time of T-cell infusion (criteria 14-15): No systemic corticosteroids within 3 days prior to T-cell infusion. 15. Not experiencing any new Grade >2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to T-cell infusion. 16. for administration of IL-2 after T-cell infusion: Absence of new adverse event of grade >2 (CTC vs. 4) involving cardiopulmonary, hepatic (excluding albumin), gastrointestinal, neurologic, or renal toxicity probably or definitely attributed to infused T cells within one week of cells Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 2. Patients with known allergy to bovine or murine products. 3. Positive serology for HIV
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Amyloidosis Understand and voluntarily sign an informed consent form. 2. Age >=18 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Confirmed diagnosis of AL amyloidosis (see appendix 3) 5. Need for treatment in the judgment of their treating physician 6. Evaluable or measurable disease defined by any of the following Measurable serum free light chains >= 10 mg/dL, kappa or lambda, provided kappa/lambda ratio is abnormal (measurable disease) Monoclonal protein in the serum >= 1 g/dL 7. ECOG Performance Status (PS) 0, 1, 2 or 3 8. Laboratory test results within these ranges Absolute neutrophil count >= 1.5 x 109/L Platelet count >= 100 x 109/L Serum creatinine >= 2.5 mg/dL Total bilirubin >= 1.5 mg/dL AST (SGOT) and ALT (SGPT) > 2 x ULN or > 5 x ULN if hepatic metastases are present. 9. Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 days prior to therapy and repeated within 24 hours of starting study drug and must begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. (See Appendix 1 Pregnancy Testing Guidelines and Acceptable Birth Control Methods.) 10. Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast 11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin) Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis (Appendix 3) 2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 5. Use of any other experimental drug or therapy within 28 days of baseline. 6. Known hypersensitivity to thalidomide. 7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 8. Any prior use of lenalidomide. 9. Concurrent use of other anti-cancer agents or treatments. 10. Known positive for HIV or infectious hepatitis, type A, B or C. 11. > grade 2 peripheral neuropathy 12. Life expectancy < 3 months 13. Concurrent use of steroids (Patients may receive prednisone up to 20 mg/d, or equivalent corticosteroids for concurrent illness or adrenal replacement therapy
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate Measurable serum and/or urinary paraprotein European Cooperative Oncology Group performance status 0-3 Serum bilirubin < 1.5x the upper limit of normal (ULN) Serum alanine transaminase (ALT)/aspartate transaminase values < 2.5 x ULN Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study Woman of child bearing potential Non-secretory MM Serum creatinine > 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug) Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Refractory Multiple Myeloma ECOG performance status (PS) 0, 1, or 2 Diagnosis of symptomatic multiple myeloma High risk myeloma as defined by progressive disease =< 12 months after high dose chemotherapy and autologous HSC transplant or presences of poor prognostic features such as deletion of chromosome 13 or hypodiploidy by standard cytogenetics, or t(4; 14) by fluorescence in situ hybridization (FISH), or t(14;16) by FISH, or 17p by FISH, or plasma cell labeling index >= 3% Availability of a HLA fully-matched or 1 mismatch related donor by low-resolution HLA typing for the loci A, B, C, DRB1 and DQB1 or HLA fully-matched unrelated donor by high-resolution typing for loci A, B, C and DRB1 and at least low-resolution for loci DQB1 Recovery from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity) Physically and psychologically capable of undergoing bone marrow or PBSC transplant Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the during of the study Male subject agrees to use an acceptable method for contraception for the duration of the study Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities NOTE: Prior to study entry, and ECG abnormality at screening has to be documented by the investigator as not medically relevant Significant cardiac dysfunction defined as left ventricle ejection fraction < 40% or presence of symptomatic coronary artery disease Significant pulmonary disease defined as FEV < 50% or CLCO < 50% of the predicted values Pre existing peripheral neuropathy grade > 1 Significant renal dysfunction defined as estimated creatinine clearance < 50 ml/min Significant liver dysfunction defined as total bilirubin >= 2 x upper limit of normal (ULN) or AST, ALT >= 3 x ULN Seroreactive for HIV, HTLV I or II, HBV, HCV Presence of uncontrolled bacterial, viral, or fungal infection Known allergy to any of the component of the investigational treatment regimen or required ancillary treatments
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Refractory Heart Failure Patient must be at least 18 years of age at the time of VAD implantation. 2. Listed for cardiac transplantation as UNOS Status 1A or 1B at the time of VAD implantation or within 72 hours of VAD implantation. 3. Body Surface Area (BSA) 1.2 m2 or greater. 4. If female of childbearing potential must have negative pregnancy test. 5. Patient has signed an Informed Consent Unacceptable surgical risk according to Principal Investigator. 2. Intolerance or contraindication to anticoagulation or antiplatelet therapies. 3. Excessive risk of bleeding as evidenced by INR > 2.3, or PTT > 45 sec, or platelet count < 50,000 U, unresponsive to treatment. 4. Excessive neurologic risk documented as TIA within the last 3 months or stroke within the last 6 months. 5. Evidence of any of the following indicators of end-organ dysfunction: total bilirubin > 4 mg/dL, ALT/AST > 3 times upper limit normal, serum creatinine >3.5 mg/dL. 6. Fixed pulmonary hypertension with a most recent PVR > 5 Wood units unresponsive to pharmacological intervention. 7. Severe chronic obstructive pulmonary disease as evidenced by an FEV1 < 1.0 L or restrictive lung disease or prolonged (> 48 hours) intubation. 8. Presence of mechanical aortic valve that will not be converted to a bioprosthesis during VAD implantation. 9. Planned concomitant surgical procedures other than aortic valve repair or tissue valve placement to treat moderate to severe aortic insufficiency, tricuspid valve repair, mitral valve repair, critical lesion CABG, LV thrombectomy (apical), closure of persistent foramen ovale, atrial septal defect. 10. Cardiogenic shock secondary to acute myocardial infarction. 11. Presence of ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation. 12. Presence of uncontrolled infection. 13. BMI > 40 kg/m2. 14. Significant peripheral vascular disease accompanied by pain at rest, extremity ulceration or disabling claudication. 15. Illness, other than heart disease, that would limit survival to less than 1 year. 16. Pulmonary embolus < 2 weeks before VAD implant. 17. Poor/compromising nutritional status in judgment of Principal Investigator. 18. Participation in another clinical trial that, according to the Principal Investigator, is likely to affect the Study outcome or confound the results
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-75.0, B-Cell Prolymphocytic Leukemia Hypodiploidy Loss of Chromosome 17p Plasma Cell Leukemia Progression of Multiple Myeloma or Plasma Cell Leukemia Recurrent Adult Hodgkin Lymphoma Recurrent Adult Non-Hodgkin Lymphoma Recurrent Childhood Hodgkin Lymphoma Recurrent Childhood Non-Hodgkin Lymphoma Recurrent Chronic Lymphocytic Leukemia Recurrent Plasma Cell Myeloma Recurrent Small Lymphocytic Lymphoma Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Non-Hodgkin Lymphoma Refractory Plasma Cell Myeloma Refractory Small Lymphocytic Lymphoma t(14;16) t(4;14) T-Cell Prolymphocytic Leukemia Waldenstrom Macroglobulinemia Must have the capacity to give informed consent Detectable tumor prior to mobilization regimen Patients with stored autologous stem cells will be allowed Stem cells from an identical donor could be used for autologous hematopoietic cell transplant (HCT) Marrow is the preferred source of stem cells from the HLA-haploidentical donor, however, peripheral blood mononuclear cells (PBMC) could be used as stem cell source, after clearance with the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator, in the case of difficulties or contraindications to bone marrow harvest from the donor Cross-over to other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) will be allowed if a suitable HLA-matched related or unrelated donor is identified before receiving the allogeneic transplantation and if the patient meets the of the subsequent study Cross-over from other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) will be allowed if the patient loses the suitable HLA-matched related or unrelated donor but has an available HLA-haploidentical donor before receiving the allogeneic transplantation and if the patient meets the of the subsequent study Lymphoma: patients with Diagnosis of non-Hodgkin lymphoma (NHL) or Hodgkin's lymphoma (HL), of any histological grade Refractory or relapsed disease after standard chemotherapy Life expectancy severely limited by disease other than malignancy Seropositive for the human immunodeficiency virus Female patients who are pregnant or breastfeeding Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years This does not apply to patients with non-hematologic malignancies that do not require therapy Patients with fungal infection and radiological progression after receipt of amphotericin B or active triazole for greater than 1 month Symptomatic coronary artery disease or ejection fraction < 40% or other cardiac failure requiring therapy (or, if unable to obtain ejection fraction, shortening fraction of < 26%); ejection fraction is required if the patient has a history of anthracyclines or history of cardiac disease; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist Corrected diffusion capacity of the lungs for carbon monoxide (DLCO) < 50% of predicted, forced expiratory volume in one second (FEV1) < 50% of predicted, and/or receiving supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study must approve of enrollment of all patients with pulmonary nodules
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-75.0, Multiple Myeloma Age 18 to 75 years, inclusive. 2. Subjects must have multiple myeloma which requires treatment for relapsed disease and are eligible for the planned autologous HSCT. 3. Subjects must have had one previous autologous HSCT, at least one year prior to the planned autologous HSCT in this study. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. 5. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test in all women of child-bearing potential. 6. Subjects who are surgically sterile (ie, have undergone orchidectomy or hysterectomy); female subjects who have been postmenopausal for at least 12 consecutive months; or subjects who agree to remain abstinent or to practice double-barrier forms of birth control from trial screening through 30 days (for females) and 90 days (for males) from the last dose of the investigational medicinal product (IMP). If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), birth control pill, birth control implant, condom, or sponge with spermicide. 7. Subjects in whom the minimum stem cell dose of 2.0 x 10^6 cluster of differentiation 34 (CD34)+ cells/kg has been collected. 8. Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Principal Investigator, to comply with all requirements of the study Prior treatment history of allogeneic HSCT for any medical reason, not limited to myeloma treatment. 2. Prior treatment history of more than one autologous HSCT or high-dose chemotherapy with stem cell rescue for any medical reason, not limited to myeloma treatment. 3. Prior treatment with busulfan or gemtuzumab ozogamicin for any reason. 4. Presence of a t(4;14) or p53 gene deletion as determined by fluorescence in situ hybridization (FISH) during the screening process or documented t(4; 14) or p53 gene deletion obtained during a time of active disease by any method. 5. Systemic amyloidosis. 6. Known allergy to boron or any components of bortezomib. 7. Left ventricular ejection fraction (LVEF) < 45% as measured by either multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) performed within 75 days prior to day of busulfan test dose. If cyclophosphamide was used for stem cell harvest, an ECHO or MUGA must be done prior to enrollment to confirm adequate cardiac function. 8. Uncontrolled arrhythmia or symptomatic cardiac disease at the time of screening. 9. Symptomatic pulmonary disease, based on Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) < 50% of predicted (corrected for hemoglobin) measured within 75 days prior to day of busulfan test dose. 10. Aspartate transaminase (AST)/alanine transaminase (ALT) ≥ 3 x the upper limit of normal (ULN), 11. History of elevated total serum bilirubin >2 mg/dL that had been caused by previous chemotherapy at any point, or total bilirubin > 2.0 mg/dL at the time of screening with the exception of Gilbert's disease. 12. Hepatic synthetic dysfunction evident International Normalized Ratio (INR) ≥ 2.0 at the time of screening. 13. Any previous history of fulminant liver failure, cirrhosis, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, and symptomatic biliary disease. 14. Prior total body irradiation therapy or radiation therapy directly applied to the liver. 15. Known history of or current hepatitis B, hepatitis C, HIV, or uncontrolled active infection of any kind at the time of test dose. If serology antibody studies are positive, a quantitative polymerase chain reaction (PCR) must be completed to confirm lack of active infection. 16. Serum creatinine >2.0 mg/dL at the time of Screening. 17. ≥ Grade 1 neuropathy with pain, or > Grade 2 neuropathy without pain (subjects with neuropathy caused by a previous regimen that is recovered to ≤ Grade 2 and stable without pain may be included). 18. Women who are pregnant or lactating. 19. Current or history of drug and/or alcohol abuse. 20. Use of other investigational therapies within 30 days
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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