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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. | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patient has a previous diagnosis of multiple myeloma. 2. Patient requires retreatment for multiple myeloma 3. Patient has measurable M component in serum or urine at study screening Patient who has progressed under all prior lines of anti MM therapy 2. Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose 3. Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information 4. Patient received prior treatment with DAC inhibitors including panobinostat 5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG 6. Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes 7. Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment. Other protocol-defined inclusion/ | 2 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Key The patient has relapsed multiple myeloma that has progressed following therapies that included bortezomib and an IMiD (thalidomide or lenalidomide) either alone or in any combination multiple myeloma, which is refractory to the most recent therapy (bortezomib or IMiD, or any other chemotherapy), or the patient did not tolerate and discontinued the most recent therapy for multiple myeloma but has recovered from its toxic effects measurable disease defined as 1 of the following serum M-protein ≥0.5 g/dL urine M-protein ≥200 mg/24 hours a life expectancy of more than 3 months an ECOG performance status of 0, 1, or 2 adequate hepatic organ function an absolute neutrophil count (ANC), hemoglobin level, and platelet count within protocol-specific ranges The patient has nonmeasurable multiple myeloma received glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 2 weeks prior to the first dose of study drug has POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy or monoclonal proliferative disorder, and skin changes) has plasma cell leukemia received chemotherapy with approved anticancer therapeutics within 2 weeks, or within 5 drug half-lives (t1/2), or investigative anticancer therapeutics within 4 weeks, or within 5 drug half-lives (t1/2), before the first dose of study drug, whichever time is greater received radiation therapy or immunotherapy in the 4 weeks prior to, or localized radiation therapy within 1 week prior to, the first dose of study drug received prior treatment with CEP-18770 has used a medication known to be a potent inducer of CYP2E1, CYP2D6 or CYP3A4/5 within 4 weeks prior to the first dose of study drug has used a medication known to be a potent inhibitor of CYP2E1, CYP2D6 or CYP3A4/5 within 2 weeks prior to the first dose of study drug | 2 |
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. | eligible ages (years): 18.0-999.0, Treatment Stem Cell Transplantation Previously untreated Ph+ ALL more than 60 years old or more than 18 years old, but unfit for program of intensive therapy and allogeneic SCT | 0 |
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. | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
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. | eligible ages (years): 18.0-70.0, Antiphospholipid Antibody Syndrome End Stage Renal Disease Age 18 years or older History of Catastrophic Antiphospholipid Antibody Syndrome (CAPS) End-stage renal disease Any contraindications to transplantation other than CAPS Pregnant women Women who intend to become pregnant over the study period Ongoing or untreated meningococcal infections History of serious adverse reaction to eculizumab | 0 |
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. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
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. | eligible ages (years): 0.0-999.0, Multiple Myeloma > 18 years, with multiple myeloma and indication for an autologous HSCT Available related haploidentical donor Written informed consent Patients scheduled for autologous/allogeneic tandem HSCT | 2 |
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. | eligible ages (years): 18.0-999.0, Cartilage Injury Osteoarthritis Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included) Male or female patients at least 18 years of age Patients whose lesion (unilateral joint) is 2 ㎠ ~ 9㎠ in size Patients with articular swelling, tenderness and active range of motion of Grade 2 or below Patients with pain in affected joint of 60-mm or below on a 100-mm VAS (visual analogue scale) Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT <1.5×control Patients with adequate renal function, Creatinine ≤ 2.0 ㎎/㎗, levels of proteinuria measured with Dipstick: trace or less Patients with adequate hepatic function, Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L Patients who have received no surgery or radiation therapy in the affected joint within the past 6 six weeks, and have recovered from the side effects of such past treatments Female patients of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study Patients with autoimmune disease or the medical history Patients with infections requiring parenteral administration of antibiotics Patients with myocardial infarction, ischemic heart failure, other serious heart conditions or uncontrolled hypertension, or any medical history of such diseases Patients with serious internal diseases Patients who are currently pregnant or nursing Patients with psychotic diseases, epilepsy, or any history of such diseases Patients with alcohol abuse Patients who smoke excessively Patients with chronic inflammatory articular diseases such as rheumatoid arthritis Patients who were enrolled in any other clinical trials within the past four weeks | 0 |
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. | eligible ages (years): 65.0-999.0, Multiple Myeloma Symptomatic multiple myeloma (MM) patient at the time of diagnosis (but not necessarily at the time of relapse), according to International Myeloma Working Group criteria Patient having received conventional chemotherapy in 1st line treatment because of age 65 years or over, or younger than 65 years and ineligible to high-dose therapy plus stem cell transplantation Measurable disease (≥10g/L monoclonal gammapathy and/or ≥ 200 mg/24h proteinuria or involved serum free light chain ≥ 100mg/L with abnormal FLC ratio < 0.26 or > 1.65) Patient in 1st relapse or refractory to 1st line therapy. Relapse is defined by M-component increase of ≥25% from baseline, in serum and/or urine (the absolute increase in serum must be ≥ 5 g/l the absolute increase of BJ proteins in urine must be ≥200 mg/24 h). (It is recommended to treat only symptomatic or rapidly evolutive relapses) Life expectancy of at least 3 months ECOG performance status <= 2 at study entry Laboratory test results within these ranges Absolute neutrophil count >= 1.5 x 109/L Platelet count >= 100 x 109/L Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Any comorbidity which places the subject at unacceptable risk if he/she were to participate in the study Patients treated with high-dose therapy plus stem cell transplantation in 1st line therapy Any prior use of bortezomib (Velcade) or bendamustine (Ribomustin) Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan Use of any other experimental drug or therapy within 28 days prior to the start of study treatment Known hypersensitivity to the study drugs Positive HIV serology, positive hepatitis C serology, active infection hepatitis A, active infection hepatitis B Severe cardiovascular disorders within 12 months prior to the start of study treatment (e.g. myocardial infarct, ischemic episodes, arrhythmias) Previous major surgery less than 30 days before start of treatment | 2 |
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. | eligible ages (years): 19.0-999.0, Multiple Myeloma Key Must be able to understand and voluntarily sign an informed consent form Must be able to adhere to the study visit schedule and other protocol requirements years>=Age Life expectancy>6 months Patients must have Symptomatic and Progressive Myeloma following bortezomib and/or lenalidomide treatment, defined as detailed in protocol Patients must have a clearly detectable and quantifiable monoclonal M-component value* ECOG performance status score of 0,1,or 2 Adequate bone marrow function,documented within 72 hours prior to treatment without transfusion or growth factor support,defined as* Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation Pregnant or breast feeding females Use of any other experimental drug or therapy within 15 days of screening Known positive for HIV or infectious hepatitis,type A, B or C Patients with non-secretory MM Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for >= 3 years.Exceptions the following* Prior local irradiation within two weeks before screening Evidence of central nervous system involvement Any>grade 2 toxicity unresolved Peripheral neuropathy>=Grade 2 | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients must have histologically or cytologically confirmed relapsed, primary refractory, or relapsed and refractory multiple myeloma Patients must have measurable disease as defined by the International Uniform Response Criteria,defined as any of the following serum M-protein of > = 500mg/dL urine M-protein of > = 200mg/ 24 hours involved free light chain > = 10mg/dL provided serum free light chain ratio is abnormal Patients must have received at least one prior line of therapy Age > = 18 years Life expectancy of greater than 12 weeks ECOG performance status > = 2 All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist Patients who have had myeloma therapy within 14 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received bisphosphonate therapy as part of routine myeloma care at any time prior to study entry Patients may not be receiving any other investigational agents History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide (including thalidomide) or melphalan Known positive for HIV or infectious hepatitis, type B or C Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown History of thrombosis or thromboembolic event within last 60 days prior to study entry | 2 |
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. | eligible ages (years): 18.0-65.0, Multiple Myeloma Plasma Cell Myeloma Newly diagnosed active multiple myeloma (MM) Measurable disease Non-secretory disease allowed provided patient has ≥ 20% plasmacytosis or multiple (> 3) focal plasmacytomas on skeletal survey and/or MRI Zubrod performance status (PS) 0-2 (Zubrod PS 3-4 allowed if based solely on bone pain) ANC ≥ 1,500/mm^3* Platelet count ≥ 150,000/mm^3* Serum creatinine clearance of ≥ 60 mL/min Patients with creatinine clearance of < 60 mL/min receive a lower dose of melphalan No patients receiving or planning to receive dialysis Total bilirubin ≤ 1.5 times upper limit of normal | 1 |
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. | eligible ages (years): 18.0-999.0, Relapsed or Refractory Multiple Myeloma Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment. 2. Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1) 3. Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen. 4. Presence of measurable disease as defined by at least one of the following Serum M-protein ≥ 1g/dL (measurable disease) Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease) Patients with non-secretory, or oligosecretory, multiple myeloma. 2. Patients with symptomatic amyloidosis, or with plasma cell leukemia. 3. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy. Other protocol-defined inclusion/ | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Age > 65 year old and not a candidate for stem cell transplant, or younger who refuses or is not eligible for high-dose therapy Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage Presence of measurable disease Karnofsky performance status (PS) > 60% Able to read and complete the HRQOL instruments Agrees to use an acceptable barrier method for contraception for the duration of the study Pretreatment clinical laboratory values within 14 days of randomization: platelet count ≥ 100x109/L hemoglobin ≥ 8 g/dL absolute neutrophil count (ANC) ≥ 1.0x109/L AST ≤ 2.5 times the upper limit of normal Diagnosis of smoldering multiple myeloma or MGUS Diagnosis of Waldenstrom's disease Prior or current systemic therapy for multiple myeloma including steroids (with exception of emergency use of a short course [maximum 4 days] of steroids before randomization or prior or current use of biphosphonates) Radiation therapy within 30 days before randomization Plasmapheresis within 30 days before randomization Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery) History of allergic reaction attributable to compounds containing boron or mannitol, or to Thalidomide Peripheral neuropathy Grade 2 or higher, as defined by National Cancer Institute Common Toxicity (NCI CTC) 3.0 Uncontrolled or severe cardiovascular disease including myocardial infarction 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 Other malignancy within the past 5 years. Exceptions: basal cell or non metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 carcinoma of the cervix | 1 |
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. | eligible ages (years): 20.0-79.0, End-Stage Renal Disease Subjects with end-stage renal disease who were receiving haemodialysis. Subject who are able and willing to give written informed consent Subjects with known hypersensitivity to drugs or foods. Subjects with a corrected QT interval greater than 450 msec at Screening period | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Accepts Healthy Volunteers: No 1. Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed. 2. Signed either an IRB or IEC approved informed consent 3. ECOG performance status of ≤ 2 4. Life expectancy of at least 3 months 5. M protein in either serum or urine, or free light chains if not measurable M protein in serum or urine, and clonal bone marrow plasma cells > 10%, and evidence of end organ damage 6. Adequate hematologic status, liver and renal function 7. Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug 2. Any other severe, acute or chronic illness 3. No other prior or concurrent malignancy 4. No immunosuppressant therapy | 2 |
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. | eligible ages (years): 18.0-999.0, Small-Fiber Neuropathy Chronic Kidney Disease The patients should fulfill the of CKD according to renal function study and the patients of end-stage renal disease should receive regular dialysis therapy and follow-up at outpatient clinics For disease comparison, patients with peripheral neuropathy of variable etiologies will also be recruited Poor control DM Severe heart failure Bleeding tendency Severe lung disease with respiratory distress Severe infection Alcoholism Amyloidosis Poor wound healing history | 0 |
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. | eligible ages (years): 18.0-999.0, Amyloidosis Histological diagnosis of primary systemic (AL) amyloidosis based on: 1. Deposition of amyloid material by congo red stain showing characteristic green birefringence, and 2. monoclonal light chain protein in the serum or urine or immunohistochemical studies or serum free light chain assay and 3. evidence of tissue involvement other than carpal tunnel syndrome, i.e. positive immunohistochemical staining of bone marrow demonstrating clonal plasma cells; or tissue amyloid deposits with anti-kappa or anti-lambda anti-serum; evidence for a plasma cell dyscrasia (PCD) by serum/urine or bone marrow; or overwhelmingly convincing clinical features e.g. macroglossia, associated with other systemic manifestations. Note: Patients with senile, secondary, localized, dialysis-related or familial amyloidosis are not eligible. Confirmation of tissue diagnosis at all sites of organ dysfunction is encouraged, but not required Must be at least 18 years of age Must have a performance status of 0-2 by Southwest Oncology Group Must have left ventricular ejection fraction (LVEF) at least 45% by echocardiogram within 60 days of enrollment Prior chemotherapy with alkylating agent allowed only if no evidence of Myelodysplastic Dysplastic Syndrome (MDS) morphologically or cytogenetically. Total cumulative dose of oral melphalan must be less than 300 mg. Patients should not have received any cytotoxic therapy less than 4 weeks prior to registration and should have fully recovered from the effects of such therapy Pulmonary Function Tests must show Diffusing capacity of the lungs for carbon monoxide (DLCO) at least 50% 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 (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study Male subject agrees to use an acceptable method for contraception for the duration of the study No overt multiple myeloma (over 30% bone marrow plasmacytosis, extensive (great than 2) lytic lesions, hypercalcemia) No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years No known to be HIV positive No platelet count of less than or equal to 70,000 within 14 days before enrollment No absolute neutrophil count of less than or equal to 1000 within 14 days before enrollment No greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment No myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), 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 No hypersensitivity to bortezomib, boron or mannitol No pregnant or breast-feeding females. 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 Must not have received other investigational drugs with 14 days before enrollment | 0 |
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. | eligible ages (years): 18.0-999.0, Relapsed and Bortezomib Refractory Multiple Myeloma Refractory Multiple Myeloma Multiple Myeloma in Relapse Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003 definitions. All three of the following must have been met Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on serum or on total 24 hour urine Bone marrow (clonal) plasma cells ≥ 10% or biopsy proven plasmacytoma Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections) 2. Patient must have relapsed and refractory MM and must require treatment for the relapsed disease 3. Patients must have received at least 2 prior lines of therapy which an IMiD (thalidomide or lenalidomide) 4. Patient must be refractory to the last bortezomib containing line of therapy given in the relapsed and refractory setting defined as having progressed on or within 60 days of the last bortezomib-containing line of therapy 5. Patient has measurable disease on M protein at study screening defined by at least one of the following measurements as per thresholds clarified in IMWG 2003 disease definitions (Kyle, et al 2003) Serum M-protein ≥ 1 g/dL (≥ 10 g/L) Urine M-protein ≥ 200 mg/24 h 6. Patients treated with local radiotherapy with or without concomitant exposure to steroids for pain control or management of cord/nerve root compression, are eligible. Two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and 2 weeks have passed since the last date of therapy 7. Patient's age is ≥ 18 years at time of signing the informed consent 8. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 9. Patient has the following laboratory values within 3 weeks before starting study drug (lab tests may be repeated, as clinically indicated, to obtain acceptable values before screen fail is concluded but supportive therapies are not to be administered within the week prior to screening tests for absolute neutrophil count or platelet counts) Absolute neutrophil count (ANC) ≥ 1.0 x 109 /L Platelet count ≥ 70 x 109 /L Serum potassium, magnesium, phosphorus, within normal limits (WNL) for institution Primary refractory disease (patients that never reached at least an MR for over 60 days under any prior therapy) 2. Patients who have a history of prior MM treatment with a DAC inhibitor including panobinostat 3. Patients who have had prior allogeneic stem cell transplantation and show evidence of active graft-versus-host disease that requires immunosuppressive therapy 4. Peripheral neuropathy ≥ CTCAE grade 2 5. Patients who will need valproic acid for any medical condition during the study or within 5 days prior to the first administration of study drug / treatment or who cannot be switch to safely to alternative anti-epileptic medication 6. Patients who have impaired cardiac function including any of the following Congenital long QT syndrome, complete left bundle branch block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (< 50 beats per minute). Right bundle branch block + left anterior hemiblock (bifascicular block) QTcF > 450 msec on screening ECG Presence of unstable atrial fibrillation. Patients with stable atrial fibrillation are allowed in the study provided they do not meet other cardiac or prohibited drug Previous history of angina pectoris or acute MI within 6 months Congestive heart failure (New York Heart Association functional classification III-IV) Patient has any other clinically significant cardiovascular disease (e.g. uncontrolled hypertension) 7. Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or significant small bowel resection) 8. Patient has unresolved diarrhea ≥ CTCAE grade 2 9. Patients who have any other concurrent severe and/or uncontrolled medical condition(s) including, but not limited to: uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease (e.g. dyspnea at rest from any cause), symptomatic thyroid dysfunction, significant bleeding tendency, that could cause unacceptable safety risks or compromise compliance with the protocol 10. Patients who are using medications that have a known relative risk of prolonging the QT interval or of inducing Torsade de Pointes, where such treatment cannot be discontinued or switched to a different medication prior to starting study drug 11. Women who are pregnant or breast feeding 12. Patients with evidence of another malignancy not in remission or history of such a malignancy within the last 5 years (except for treated basal or squamous cell carcinoma, or in situ cancer of the cervix) 13. Patients who have received prior to starting study treatment either radiation therapy to > 30% of marrow-bearing bone within 4 weeks; myelotoxic chemotherapy within 4 weeks; or immunotherapy within 8 weeks; or who have not yet recovered from side effects of such therapies 14. Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff 15. Use of chemo-, biologic or immunologic therapy and/or other investigational agents while the patient is on study treatment. 16. Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted only if commenced prior to the start of screening period) | 2 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma The patient must, according with investigator be able to comply with all the protocol requirements The patient or legal representative must sign voluntarily the informed consent before the performance of any study related procedure, not part of usual medical care, with the knowledge that can leave the study the moment he/she wants, without prejudice to later medical care years and older Patients with newly diagnosed symptomatic multiple myeloma43 which hasn't been treated previously with any chemotherapy used for this disease (see Annex 8) Patient with a measurable or evaluable disease, defined as follows For secretor multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value of IgG>10g/l or IgA > 5 g/l and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours For oligo or non-secretor multiple myeloma, measurable disease is defined by the presence of soft tissue plasmocytomas (not bone) determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with low secretor multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretor multiple myeloma, there is no M-protein in serum or urine by immunofixation ECOG performance status ≤ 2 (see Appendix 5) Patient has a life-expectancy >3 months Glomerular filtration calculated with MDRD <50 ml/min Glomerular filtration calculated with MDRD ≥ 50ml/min Asymptomatic MM with renal failure from unrelated causes Prior Velcade therapy Patients previously received treatment to Multiple Myeloma Patient had major surgery within 4 weeks previous Patient with platelet count ≤ 50 x 109/l within 14 days before enrolment Patient with absolute neutrophil count ≤ 0,75x109/l within 14 days before enrolment Patients with Grade 2 peripheral neuropathy within 14 days before enrolment Patient has hypersensitivity to bortezomib, boron or mannitol Patient has received other investigational drugs within 14 days before enrolment | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Diagnosis of multiple myeloma based on standard criteria. 2. Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1Gm/dL and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours. 3. Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible. 4. Patient must not have been previously treated with chemotherapy. Prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient. 5. Patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons Age>65 Impaired renal function (creatinine≥2.0 mg/dL) Impaired pulmonary function (DLCO≤50%) Poor performance status (KPS≤80) Other prohibitive comorbid disorder . Patients≥60 who decline autologous stem cell transplant are eligible for this study . Patients who are eligible but wish to postpone autologous stem cell transplant are eligible for this study. 6. Karnofsky performance status>50 7. Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period Spot RT to ≤3 vertebrae acceptable prior to entry. 8. Meets the following pretreatment laboratory at Baseline (Within 14 days prior to study drug administration): 1. Platelet count>50x10^9/L or, if the bone marrow is extensively infiltrated,>30x10^9/L 2. Hemoglobin>8.0G/dL 3. Absolute neutrophil count >1.0x10^9/L or, if the bone marrow is extensively infiltrated, >0.5x10^9/L 9. Meets the following pretreatment laboratory for liver function tests at the screening visit conducted within 14 days of registration 1. AST (SGOT): <3 times the upper limit of institutional laboratory normal 2. ALT (SGPT): <3 times the upper limit of institutional laboratory normal 3. Total bilirubin: <2 times the upper limit of institutional laboratory normal, unless clearly related to the disease 10. Women with child-bearing potential should be practicing an adequate form of contraception, as judged by the investigator (i.e. birth control pills, double barrier method, abstinence, etc.) or be surgically sterile or 12 months post-menopausal. Male subject agrees to use an acceptable method for contraception for the duration of the study. 11. Age 18 years or older 12. Has given voluntary written informed consent POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes) 2. Plasma cell leukemia 3. Impaired kidney function requiring dialysis, patients on hemodialysis are excluded 4. Receiving steroids >the equivalent of 10mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis 5. Infection not controlled by antibiotics 6. HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice 7. Known active hepatitis B or C 8. Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 9. Second malignancy requiring concurrent treatment 10. Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol 11. Positive pregnancy test in women of childbearing potential 12. Patient has hypersensitivity to boron or mannitol. 13. Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment. 14. Patient has received other investigational drugs with 14 days before enrollment | 1 |
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. | eligible ages (years): 18.0-999.0, 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 Patient is 65 years old or older at the time of signing the informed consent or younger patients not candidate to high dose therapy Female patient is either post-menopausal or surgically sterilized or, if at child-bearing potential†, must understand that the study medication could have an expected teratogenic risk Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception* Implant** Levonorgestrel-releasing intrauterine system (IUS)** Medroxyprogesterone acetate depot Tubal sterilisation Previous treatment with anti-myeloma therapy (does not radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days) Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study Pregnant or lactating females Prior history of malignancies, other than multiple myeloma, unless the subject 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 histologic finding of prostate cancer (TNM stage of T1a or T1b) | 1 |
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. | eligible ages (years): 18.0-999.0, Refractory Multiple Myeloma Relapsed or refractory multiple myeloma Measurable disease as defined by at least ONE of the following Serum monoclonal protein >= 1.0 g/dL > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio ≤ 5 prior therapies; stem cell transplantation and preceding induction therapy will be considered as one therapy; NOTE: Patients must not be candidates for stem cell transplantation or should have had stem cells collected previously Life expectancy of ≥ 3 months ECOG performance status of 0, 1 or 2 Absolute neutrophil count >= 1,000/mcL Platelets >= 75,000/mcL Any of the following prior therapies Myelosuppressive therapy for myeloma ≤ 3 weeks prior to registration or those who have not recovered from acute reversible adverse events due to agents administered > 3 weeks earlier Non-myelosuppressive agents like thalidomide or high dose corticosteroids ≤ 2 weeks prior to registration Receiving any other investigational agents Concomitant high dose corticosteroids NOTE: Concurrent use of corticosteroids, but patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis, etc NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or nursing women; NOTE: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SCH 727965, breastfeeding should be discontinued if the mother is treated with SCH 727965 | 2 |
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. | eligible ages (years): 18.0-999.0, Relapsed/Refractory Multiple Myeloma Age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 Life expectancy ≥ 3 months Patients previously diagnosed with multiple myeloma Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available) Women must have a negative serum pregnancy test Voluntarily signed and dated written informed consent Concomitant diseases/conditions Women who are pregnant or breast feeding Concomitant medications that corticosteroids, chemotherapy, or other therapy that is or may be active against MM Known hypersensitivity to any involved study drug or any of its formulation components | 1 |
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. | eligible ages (years): 0.0-70.0, Multiple Myeloma Patients meeting the for symptomatic multiple myeloma (MM) Patients who are 70 years of age, or younger, at time of enrollment Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 months of the first dose of initial therapy Cardiac function: left ventricular ejection fraction at rest greater than 40 percent Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.) Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin) Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight Signed informed consent form Patients who never fulfill the for symptomatic MM Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques]. Patients with light chain MM detected in the serum by free light chain assay are eligible Patients with plasma cell leukemia Karnofsky performance score less than 70 percent Patients with greater than grade 2 sensory neuropathy (CTCAE) Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms) Patients seropositive for the human immunodeficiency virus (HIV) Myocardial infarction within 6 months prior to 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. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant Patient has hypersensitivity to bortezomib, boron or mannitol Patient has received other investigational drugs with 14 days before enrollment | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma The patient has relapsed or refractory multiple myeloma that has progressed following at least on prior therapy Relapsed myeloma is defined in patients as at least 25% increasing monoclonal (M)-protein in serum or urine or in the size of a plasmacytoma compared to a best response reached after previous therapy Refractory myeloma is defined as failure to achieve at least a minor response (patient achieved stable disease as his/her best response) or progression of disease on current therapy or within 60 days of last dose of current therapy The patient has measurable disease defined as one of the following: 1. serum M-protein >=1 g/dL 2. urine M-protein >=200 mg/24 hours Must have received at least one (1) prior line of systemic treatment that may have included a. NOTE: Patients may have undergone prior allogeneic or autologous stem cell transplantation (stem cell transplant with high dose induction chemotherapy with/without planned maintenance therapy will be considered one line of therapy) No cytotoxic chemotherapy within 4 weeks prior to registration for protocol therapy. a. NOTE: this interval may be reduced to 14 days for thalidomide, lenalidomide, or corticosteroids, provided other entry are met No concurrent steroid use in doses greater than 10 mg daily of Prednisone (or equivalent) if given for management of co-morbid conditions Age >= 18 at the time of consent The patient has a life expectancy of more than 3 months No known central nervous system involvement by myeloma The patient has nonmeasurable multiple myeloma, defined as less than 1g/dl M-protein in serum and less than 200 mg/24 hours M-protein in urine The patient received glucocorticoid therapy (prednisone > 10 mg/day orally or equivalent) within the last 2 weeks prior to the first dose of study drug The patient received chemotherapy with approved or investigative anticancer therapeutics within 4 weeks. a. NOTE: this interval may be reduced to 14 days for thalidomide, lenalidomide, or corticosteroids, provided other entry are met The patient has an acute infection requiring systemic antibiotics, antiviral agents, or antifungal agents within 2 weeks before the first dose of study drug The patient has grade 2 or higher neuropathy within 14 days of enrollment The patient has any serious psychiatric or medical condition that could interfere with treatment and study procedures, place the patient at unacceptable risk, or confound the ability of investigators to interpret study data The patient is a pregnant or lactating woman Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix A), 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 Patient has hypersensitivity to boron or mannitol Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy | 2 |
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. | eligible ages (years): 18.0-65.0, Multiple Myeloma Confirmed diagnosis of symptomatic MM based on standard criteria No prior or current systemic therapy for MM, including steroids At least 18 years and less than 65 years of age Presence of quantifiable M protein in serum (e.g. greater than 1 g/dL for IgG MM, greater than 0.5 g/dL of IgA or IgD MM) or urine (e.g. greater than 200 mg/day for BJ MM) Karnofsky performance status (PS) at least 60% Willing and able to comply with the protocol requirements Agreement from both male and female patients to follow the risk management program established for the prevention of pregnancy, including double methods for contraception and beta-HCG tests for women of childbearing potential and contraception for males Adequate organ function, including heart, liver, kidney (serum creatinine less than 2 mg/dL) Platelet count at least 70 x 10/mcL and absolute neutrophil count at least 1 x 10/mcl Diagnosis of asymptomatic MM or of MGUS based on standard criteria Diagnosis of non-secretory MM Diagnosis of AL Amyloidosis Prior or current systemic therapy for MM, including steroids (with exception of bisphosphonates) Patient has received other investigational drugs within 30 days before enrollment Female subjects pregnant or breastfeeding Patient has Grade 2 or higher peripheral neuropathy (NCI criteria) Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism Patient has a previous diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency Patient has a clear indication to receive a specific other anti-platelet therapy (e.g. clopidogrel, ticlopidine) | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Phase I: Patients with diagnosis of multiple myeloma at any stage of disease undergoing high dose chemotherapy and stem cell transplantation Phase II: Patients with myeloma undergoing a first high dose chemotherapy and stem cell transplantation after achieving at least stable disease following induction therapy. Any induction regimen prior to transplantation is allowed. No more than 2 prior lines of therapy prior to transplantation are allowed All previous therapy not associated with peripheral blood stem cell transplant, including radiation, hormonal therapy, and surgery, must have been discontinued 4 weeks prior to treatment in this study ECOG performance status of </= 2 at study entry Laboratory test results within protocol-specified ranges 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 must have negative pregnancy test within 24 hours of first prescription for lenalidomide and must commit to either continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control Able to take aspirin daily as prophylactic anticoagulation Subject must have the minimum stem cell dose of 5.0 x 10^6 CD34+ cells/kg collected Pregnant or breast feeding females History of intolerance or resistance to lenalidomide Known hypersensitivity to thalidomide The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs Known seropositive for or active viral infection with human immunodeficiency vrus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis b virus vaccine are eligible | 2 |
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. | eligible ages (years): 18.0-999.0, End Stage Renal Disease Chronic Kidney Disease Cardiovascular Event Sudden Cardiac Death Age 18 or older 2. End-stage renal disease (ESRD) and receiving maintenance hemodialysis Any clinically significant infection. 2. pregnancy 3. history of malignant disease with a prognostic life expectancy less than 24 months 4. missing of written and informed consent | 0 |
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. | eligible ages (years): 18.0-70.0, Multiple Myeloma Patient referred to one of the hematology departement associated with the research project, with confirmed multiple myeloma defined according to uniform international criteria Whatever stage classification according to Salmon and Durie with a life expectancy of more than 3 months Age under 70 years old (amendment n°5) and eligible for autologous stem cell transplantation Free and informed consent Patient unfit physically, mentally or legally to give informed consent Patient non affiliate with social security scheme Patient with myeloma without measurable monoclonal immunoglobulin, including measurement of serum free light chains Patient with another malignancy excluding basal cell cancer Patient who could not undergo MRI (incompatible metallic foreign body, pacemaker, allergy to contrast, claustrophobia despite premedication, pregnancy, renal failure with creatinine clearance <30 ml/min | 0 |
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. | eligible ages (years): 0.0-999.0, Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) 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 Acute Myelomonocytic Leukemia (M4) Adult Acute Promyelocytic Leukemia (M3) Adult Erythroleukemia (M6a) Adult Nasal Type Extranodal NK/T-cell Lymphoma Adult Pure Erythroid Leukemia (M6b) Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Burkitt Lymphoma Childhood Acute Erythroleukemia (M6) Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Megakaryocytic Leukemia (M7) Childhood Acute Monoblastic Leukemia (M5a) Childhood Acute Monocytic Leukemia (M5b) Childhood Acute Myeloblastic Leukemia With Maturation (M2) Childhood Acute Myeloblastic Leukemia Without Maturation (M1) Childhood Acute Myeloid Leukemia in Remission Childhood Acute Myelomonocytic Leukemia (M4) Childhood Acute Promyelocytic Leukemia (M3) Childhood Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Chronic Phase Chronic Myelogenous Leukemia Cutaneous B-cell Non-Hodgkin Lymphoma De Novo Myelodysplastic Syndromes 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 Post-transplant Lymphoproliferative Disorder Previously Treated Myelodysplastic Syndromes 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 Non-Hodgkin Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia 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 Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Myelodysplastic Syndromes Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Testicular Lymphoma Waldenstrom Macroglobulinemia Acute non-lymphocytic leukemia (FAB types M1-M7) in first, or second remission, or early first or second bone or marrow relapse (>31% marrow blasts and no circulating peripheral blasts) All patients with acute promyelocytic leukemia in first complete remission who have received retinoic acid and chemotherapy are not eligible Acute lymphocytic leukemia in first or second remission, or early first or second bone marrow relapse (31% marrow blasts and no circulating peripheral blasts) Pediatric ALL patients in first complete remission are not eligible Chronic myelogenous leukemia in first or second chronic phase, or accelerated phase Myelodysplastic syndrome =< 50 years Lymphoma patients age =< 50 years (non Hodgkins or Hodgkins) in first or second relapse, or refractory disease, who are ineligible for autologous bone marrow transplantation because of tumor in the bone marrow Multiple myeloma patients age =< 50 who have relapsed or are refractory to at least 2 chemo-radiation or chemotherapy regimens Patients who have failed a previous allogeneic bone marrow transplant Patients with inborn errors of metabolism | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Males or females at least 18 years of age Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy Measureable disease Karnofsky Performance Status at least 60% Adequate liver and renal function and hematology laboratory values Female patients of child-bearing potential must have a negative pregnancy test Signed informed consent Treatment with systemic cancer therapy within 21 days before screening Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug Grade 3 sensory neuropathy or motor neuropathy with pain Concurrent severe or uncontrolled medical disease Active systemic fungal, bacterial, and/or viral infection Difficulty with swallowing, or an active malabsorption syndrome Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis History of gastric or small bowel surgery Pregnant or nursing females | 2 |
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. | eligible ages (years): 18.0-65.0, Osteoarthritis Female patients not pregnant or lactating Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee Diagnosis must be based on magnetic resonance imaging Both genders Age:18-65 years Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease Known allergic reaction to components of study treatment and/or study injection procedure Patients infected with hepatitis B,C or HIV | 0 |
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. | eligible ages (years): 18.0-70.0, Multiple Myeloma Meet established for the diagnosis of multiple myeloma Durie-Salmon stage II or III disease Measurable disease in the serum and/or urine Scheduled to receive high dose chemotherapy and autologous stem cell transplant for multiple myeloma Individuals who have previously undergone autologous stem cell transplant are eligible for this study provided more than 6 months have elapsed from the prior transplant Minimum stem cell dose of 4x106 CD34+ MNC / kg stored for autologous stem cell rescue Adequate hematologic reserve as evidenced by ANC ≥ 1500/mm3 and platelets ≥ 100,000/mm3 Serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 3x institution upper limit of normal Serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min (either calculated or measured) Stage I or smoldering myeloma, isolated plasmacytoma, or benign monoclonal gammopathy Non-secretory multiple myeloma Pregnant or lactating women Males and females who do not agree to practice approved methods of birth control for the duration of the study Presence of active infection Receipt of previous radiation therapy to critical organs exceeding any of the following limits: kidney 500 cGy, liver 1000 cGy, lungs 500 cGy | 1 |
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. | eligible ages (years): 18.0-999.0, Chronic Renal Failure With Uremic Nephropathy Age >=18 years old Serum creatinine > 170µmol/l and/or DFG < 40 ml/min/1.73 m2 Myeloma cast nephropathy (MCN) Multiple myeloma Informed consent neutrophils >= 1 Giga/L and platelets >= 70 Giga/L Amylosis Chronic renal Failure with eDFG < 30 ml/min/1.73 m2, unrelated to myeloma Peripheral neuropathy Contraindications to either corticosteroids or Bortezomib Patient refusal Known HIV infection Concomitant severe disease including neoplasias (except basocellular carcinoma) Liver failure, cytolysis, and/or cholestasis Fertile women who refuse or cannot use effective contraception; Women pregnant or nursing; Women with positive test pregnancy (test before treatment initiation) | 1 |
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. | eligible ages (years): 18.0-70.0, Multiple Myeloma Confirmed Multiple Myeloma as defined below within 120 days of starting cycle 1 Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma Presence of M protein in serum or urine or both. Conventional M spike, serum free light chains, or 24 hour urine study. Non-secretory myeloma is not eligible for this study In addition patient must have one of the following organ dysfunction Hypercalcemia Renal insufficiency Anemia Bone disease manifested by lytic lesion or osteoporosis (if osteoporosis is the only organ dysfunction then BM should have ≥ 30% plasma cells) Confirmed Multiple myeloma as defined above within 90 days of starting cycle 1 The following study assessments must be fulfilled and must be obtained with four weeks of starting cycle 1 Patients with smoldering myeloma or monoclonal gammopathy of unknown significance are not eligible Age > 70 years or < 18 years is not eligible Patient has > 1.5 × ULN Total Bilirubin Grade 2 or higher peripheral neuropathy due to ANY cause High index of suspicion of primary amyloid light chain (AL) amyloidosis Patients with uncontrolled inter-current illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance or a prior history of Steven Johnson syndrome Patients must not have a history of current or previous deep vein thrombosis or pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy Female patients who are breastfeeding or pregnant Patients known to be HIV positive Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 31.3), 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 | 1 |
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. | eligible ages (years): 18.0-999.0, Chronic Kidney Disease Stage 5 (Dialysis Dependent) Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to will be included if they meet all of the following 1. Men or women, aged 18 years or greater. 2. Subjects diagnosed with CKD-5D and in haemodialysis therapy for at least 90 days. 3. Life expectancy beyond 12 months by Principal Investigator's judgement. 4. Willingness and ability to participate after Informed Consent. 5. Hb concentrations between 9.5 g/dL and 12.5 g/dL (both values included) both at Screening Visit 1a and at Screening Visit 1b (screening Visit 1a and Visit 1b must be separated by at least 1 week). 6. Serum ferritin < 800 ng/mL. 7. Transferrin Saturation < 35%. 8. Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to screening (with only 1 missed dose to be allowed. Dose to be kept stable during the study period). 9. Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4 weeks (with only 1 missed dose to be allowed) Anaemia caused primarily by factors other than renal related anaemia. 2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). 3. Patients currently undergoing treatment with immunosuppresives (low dose steroids are allowed during the study conduct for dosages no more than 10 mg prednisolone/day or equivalent. If possible the dosage should be kept constant through the study). 4. Difference of Hb ≥ 1.0 g/dL between screening (Visits 1a and 1b). 5. Patients with a history of multiple allergies. 6. Decompensated liver cirrhosis or active hepatitis [Alanine Aminotransferase (ALT) > 3 times normal] or history of Hepatitis B or C. 7. Active acute or chronic infections (assessed by clinical judgement), supplied with White Blood Cells (WBC) and C reactive protein (CRP). 8. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 9. Pregnancy or nursing. [To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches] 10. Blood transfusion within the previous 12 weeks. 11. Planned elective surgery in the next 8 weeks. 12. Participation in any other clinical trial within the past 30 days, or if longer, where the study drug has not passed five half-lives prior to screening. 13. Untreated Vitamin B12 or folate deficiency. 14. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Examples Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Multiple myeloma confirmed by bone marrow aspirate or biopsy Patient had to have relapsed and/or refractory multiple myeloma after at least 1 standard therapy, and have demonstrated disease progression Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 or above had been observed during previous treatment (for Part 2 of the study only) Prior therapy with any IGF-1 system targeting compound History of allogenic stem cell transplantation in case of concomitant immunosuppressive therapy within 6 months before study entry. Patients having undergone autologous stem cell transplantation(s) may have been included in the study History of organ transplant and any patient receiving long term systemic immunosuppressive therapy The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | 2 |
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. | eligible ages (years): 18.0-75.0, Myeloma, Plasma-Cell Myeloma-Multiple Myelomatosis for Cohort A (recently diagnosed subjects; to receive autologous hematopoietic cell transplantation (AHCT)) Must have presence of clonal plasma cells in the bone marrow greater or equal to 10% or biopsy proven plasmacytoma Must have either: 1. presence of an M-component (Immunoglobulin G (IgG) or Immunoglobulin G (IgA)) in serum greater or equal to 1g/dl or in urine greater or equal to 200 mg/24 h; or 2. presence of an abnormal serum free light chain (FLC) ratio on the serum FLC assay. for Cohort B (multiply relapsed multiple myeloma) Must have measurable multiple myeloma (MM), as defined by: serum M-protein greater than or equal to 1 g/dL, urine M-protein greater than or equal to 200 mg/24 hours, involved serum free light chain (FLC) level greater than or equal to 10 mg/dL, biopsy proven plasmacytoma, or more than 30% bone marrow plasma cells Must have received at least 2 different treatment regimens for MM. Other (applies to both Cohort A and Cohort B, unless specified) Age greater than or equal to 18 years and less than or equal to 75 years. In subjects between 65 and 75 years of age, physiologic age and co-morbidity will be thoroughly evaluated before enrolling. Specifically, any history of cardio-vascular pathology or symptoms, not clearly fitting the will prompt an evaluation by a Clinical Center Cardiologist and will be considered on a case-by-case basis For Cohort A only, high-dose chemotherapy and AHCT must be planned; with amendment K, post-transplant maintenance therapy will not be permitted Karnofsky performance status (KPS) of 70% or greater. Lower KPS down to 50% may be acceptable if the restriction of activity is solely due to intractable pain from myeloma lesions Ejection fraction (EF) by multi-gated acquisition scan (MUGA) or two-dimensional (2-D) echocardiogram within institution normal limits. In case of low EF, the subject may remain eligible after a stress echocardiogram is performed if the EF is more than 35% and if the increase in EF with stress is estimated at 10% or more Serum creatinine less than or equal to 2.5 mg/dl Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal Bilirubin less than or equal to1.5 (except if due to Gilbert's disease) Corrected carbon monoxide diffusing capacity (DLCO) greater than or equal to 50% on Pulmonary Function Tests No history of abnormal bleeding tendency or predisposition to repeated infections Patients must be able to give informed consent | 2 |
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. | eligible ages (years): 18.0-75.0, Multiple Myeloma Auto Stem Cell Transplant Changed from Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III or ISS stage I, II or III, less than 12 months since initiation of systemic therapy ≥8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants Age: 18-75 years at time of transplantation KPS 70-100% Recovery from complications of prior therapies Gender: There is no gender restriction Diagnosis other than multiple myeloma Chemotherapy or radiotherapy within 8 days of initiating treatment in this study Prior autologous or allogeneic transplantation (except as enrolled into this study) Uncontrolled bacterial, viral, fungal or parasitic infections | 1 |
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. | eligible ages (years): 18.0-75.0, Multiple Myeloma Each patient must meet all of the following to be enrolled in the study 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 as described in the S.T.E.P.S program. Participation in the program is required Male subject agrees to use an acceptable method for contraception for the duration of the study as described in the S.T.E.P.S program. Participation in the program is required Confirmed diagnosis of multiple myeloma, or plasma cell leukemia Show progression of disease after a previous dose-intense cycle of melphalan, or less than a complete response after a prior cycle of dose-intense melphalan. Patients may have received more than on prior autologous transplant with high-dose melphalan May have received intervening therapies after disease progression after dose-intense melphalan and before enrollment in this protocol Recovery from complications of salvage therapy, if administered Age: ≥18 yrs but <76 yrs at the time of melphalan administration Gender: There is no gender restriction Patients meeting any of the following are not to be enrolled in the study Cytotoxic chemotherapy or radiotherapy within 21 days of initiating treatment in this study Prior dose-intense therapy within 56 days of initiating treatment in this study Uncontrolled bacterial, viral, fungal or parasitic infections Uncontrolled CNS metastases Known amyloid deposition in heart Organ dysfunction: LVEF <40% or cardiac failure not responsive to therapy. DLCO <50% of predicted and/or receiving supplementary continuous oxygen. Evidence of hepatic synthetic dysfunction, or total bilirubin >2x or AST >3x ULN. Measured creatinine clearance <20 ml/min. Sensory peripheral neuropathy grade 4 within 14 days of enrollment Karnofsky score <70% unless as a result of bone disease directly caused by myeloma Life expectancy limited by another co-morbid illness | 2 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Myeloma Smoldering Multiple Myeloma Diagnosis of smoldering multiple myeloma (SMM) will be made in accordance with the clinical diagnostic set forth by the International Myeloma Working Group. These Serum M-protein greater than or equal to 3 g/dl and/or bone marrow plasma cells greater than or equal to 10 percent Absence of anemia: Hemoglobin greater than or equal to 10 g/dl Absence of renal failure: calculated creatinine clearance (according to modification of diet in renal disease (MDRD)) greater than or equal to 40 ml/min (or alternatively based on standard creatinine level of 2 mg/dl) Absence of hypercalcemia: Calcium less than or equal to 10.5 mg/dl Absence of lytic bone lesion (skeletal survey) The diagnoses will be confirmed by serum/urine protein electrophoresis, immunofixation and light-chain assays; as well as immunohistochemical analyses of the bone marrow biopsy Age greater than or equal to 18 years Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Male or female patient who accepts and is able to use recognized effective contraception (oral contraceptives, intrauterine contraceptive device (IUCD), barrier method of contraception in conjunction with spermicidal jelly) through the study and for four months following the final dose of study drug when relevant Patients with a diagnosis of multiple myeloma (MM) or a clinical suspicion of an ongoing progression into full-blown MM Patients without measurable disease defined as serum monoclonal protein (M-protein) less than 1 g/dL Previous treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, immunomodulatory drugs (IMiDs), or proteasome inhibitors) Use of any investigational agent within the last 3 months Clinical laboratory values at screening Platelet levels less than 75 times 10^9/L Absolute neutrophil count (ANC) levels less than 1 times 10^9/L Bilirubin levels greater than 1.5 upper limit of normal (ULN) ; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3.0 ULN (grade 1 National Cancer Institute (NCI)) Primary or associated amyloidosis Known abnormal cardiac status with any of the following | 1 |
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. | eligible ages (years): 18.0-999.0, DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma Refractory Plasma Cell Myeloma Patients must have a diagnosis of multiple myeloma as defined below with staging based on the International Staging System Multiple myeloma all three required (Note: these identify stage 1B and stages II and IIIA/B myeloma by Durie/Salmon stage; stage 1A becomes smoldering or indolent myeloma) 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 (if no monoclonal protein is detected [non-secretory disease], then >= 30% monoclonal bone marrow plasma cells and/or biopsy-proven plasmacytoma is required) Myeloma-related organ dysfunction (1 or more) (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) Calcium elevation in the blood (serum calcium > 10.5 mg/L or upper limit of normal) Renal insufficiency (serum creatinine > 2mg/dL) Anemia (hemoglobin < 10 g/dL or 2 g < normal) Lytic bone lesions or osteoporosis (if a solitary [biopsy-proven] plasmacytoma or osteoporosis alone [without fractures] are the sole defining then > 30% plasma cells are required in the bone marrow) | 1 |
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. | eligible ages (years): 20.0-65.0, Multiple Myeloma Patients with a confirmed diagnosis of multiple myeloma (MM) Symptomatic MM (multiple myeloma with related organ or tissue damage) Previously untreated Age 20-65 years Performance status: ECOG 0-2 Patient has measurable disease, defined as follows: For secretory multiple myeloma, measurable disease is defined as any quantifiable serum M-protein value and, where applicable, urine light chain of ≥200 mg/24 hours For oligo-secretory multiple myeloma, measurable disease is defined as quantifiable light chain paraprotein on serum free light chain assay For non-secretory multiple myeloma, measurable disease is defined as presence of soft tissue plasmacytoma(s) as determined by clinical examination or radiographic examination such as CT scan and magnetic resonance imaging (MRI), etc Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value, Bilirubin < 2 X upper normal value Systemic AL amyloidosis, smoldering multiple myeloma or MGUS Patient with plasma cell leukemia (> 20% plasma cells in the PB and an absolute plasma cell count of at least 2000/μL) Previous chemotherapy or radiotherapy for the treatment of MM Patient is known to be Human Immunodeficiency Virus (HIV) positive Patient has known clinically active Hepatitis B or C Previous renal transplantation Severe peripheral neuropathy (Grade 2 or higher as defined by National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 3.0) Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri Pregnant or lactating women, women of childbearing potential not employing adequate contraception Other serious illness or medical conditions : i. Uncontrolled or severe cardiovascular disease, including myocardial infarction, 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 ii. History of significant neurological or psychiatric disorders including dementia or seizures iii. Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other serious medical illnesses | 1 |
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. | eligible ages (years): 18.0-65.0, Multiple Myeloma Newly diagnosed multiple myeloma patients with an HLA identical sibling suitable for PBSC donation and treated in induction with thalidomide or bortezomib or lenalidomide conteining regimes. 2. Complete cytogenetic analysis at diagnosis, including FISH analysis for chromosome deletions 13 and 17, and translocations (4;14) (11;14) and (14;16). 3. The patient must have the capacity to give informed consent. 4. Age >18 and < 65 5. If female, the patient is either postmenopausal since at least 24 consecutive months or surgically sterilized or she agrees to practice sexual abstinence or to use two reliable methods for contraception (e.g. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) for the duration of study 6. If male, the patient agrees to practice sexual abstinence or to use a latex condom during any sexual contact with women of childbearing potential for the duration of study 7. Negative pregnancy test Karnofsky score less than 60 (see appendix C), unless due solely to myeloma 2. Left ventricular ejection fraction less than 40%, or symptomatic coronary artery disease or other cardiac failure requiring therapy 3. Bilirubin greater than 2 X the upper limit of normal, or SGPT and SGOT > 4 X the upper limit of normal 4. DLCO < 40% (corrected) or receiving continuous supplemental oxygen. 5. Creatinine clearance < 40 cc/min at the time of initial autografting evaluation. 6. Patients with poorly controlled hypertension 7. Patients with active non-hematologic malignancies (except non-melanoma skin cancers). 8. Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence 9. Seropositive for HIV 10. Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment. 11. To evaluate toxicity and tolerability of lenalidomide after allografting 12. To evaluate efficacy of lenalidomide in inducing complete remission 12 months after allografting | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with multiple myeloma receiving a chemotherapy protocol including thalidomide or lenalidomide Patients involved in an interventional clinical trial | 2 |
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. | eligible ages (years): 18.0-99.0, Chronic Myelogenous Leukemia Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Hodgkins Lymphoma Non-Hodgkins Lymphoma Individuals who are candidates for allotransplant therapy for hematologic malignancies and are being evaluated at the Clinical Center for planned allotransplantation. 2. Individuals who have received allotransplant treatment for hematologic malignancy and have: 1. Hematologic recovery after allotransplant: e.g., have had neutrophil recovery to 500 cells/mcL. Secondary cytopenias or cytopenias due to disease progression will be permitted. Note: this requirement will not apply to subjects enrolling pre-transplant, i.e, who receive transplant-related medical care at the Clinical Center (CC). 2. An ongoing relationship with a primary oncologist who will continue to provide continuity of care during and after study participation. 3. Following record review and information exchange between the patients primary oncologist and the National Cancer Institute (NCI) Principal Investigator (PI)/Designee, the PI/Designee determines that the individual reasonably could be expected to safely tolerate travel to and from the Clinical Center (CC) to undergo evaluation as defined in the protocol, in the event that the patient is ineligible or uninterested in participating in open treatment protocols. 3. 18-99 years. 4. Ability of subject to understand and the willingness to sign a written informed consent document. DONOR 1. Individuals who are/will be the donors of allogeneic hematopoietic stem cell transplants received by Recipient-Subjects who are to be enrolled on this protocol. 2. Age 18-99 years. 3. Ability of the subject to understand and the willingness to sign a written informed consent document. 4. Individuals with evidence of infection with transfusion-transmittable agents (Hepatitis B and C Viruses (HBV, HCV); Human Immunodeficiency Virus (HIV (Omega)), Human TLymphotrophic Virus (HTLV I/II), West Nile Virus (WNV) and Trypanosoma cruzi) will not be excluded from study participation. However, Donor-Subjects with evidence of HIV infection will only be able to donate cells for research. Donors with a history of HBV or HCV infection will be able to donate for research, and may be eligible to donate for therapeutic administration. However, determination of permissibility for clinical donation will require a hepatology consultation and the consent of the intended recipient after discussion of the risk/benefit of the donor cell product and the possibility/consequences of transmission. The PI/Designee will make the final determination of permissibility of donation for recipient cell therapy. 6. Unrelated donor selection will be in accordance with the National Marrow Donor Program (NMDP) standards. When a potentially eligible recipient of an unrelated donor product from an NMDP Center is identified, the recipient will complete an NMDP search transfer request to allow NIH NMDP staff to contact the NMDP Coordinating Center, who will, in turn, contact the donors prior Donor Center. The NMDP Policy for Subsequent Donation Requests will be followed and the appropriate forms (Subsequent Donation Request Form and Therapeutic T Cell Collection Prescription Form) will be submitted as required Individuals with rapid disease progression or aggressive cancer histology who, in the opinion of the PI/Designee, require urgent therapy within 30 days in order to preserve organ function or quality of life. This restriction will not apply if there is no approved therapy with a reasonable chance of disease response, if the patient does not have access to an effective therapy and the patient appears to be eligible for an accruing CC treatment protocol or if the patient is enrolled on an NIH/CC clinical protocol, e.g., allotransplant protocol. 2. Pregnancy or lactating. Additionally, Recipient-Subjects of childbearing potential that will receive cancer treatment under this protocol must be willing to use an effective method of contraception. DONOR 1. Adult donors who are not eligible for clinical donation will not be excluded from study participation, but will only be able to donate cells for research | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma in Relapse Multiple Myeloma Patients must have histologically or cytologically confirmed symptomatic MM, Salmon-Durie Stage II or III, International Staging System II or III, or fulfill the CRAB (see Appendix A, B). Patients should have previously been treated with at least one cycle of bortezomib, after which the patient has shown progressive or refractory disease. Finally, patients must meet at least one of the following parameters of measurable disease Bone marrow plasmacytosis with> 10% plasma cells, or sheets of plasma cells, or biopsy proven plasmacytoma which must be obtained within 6 weeks prior to registration Measurable levels of monoclonal protein (M-protein): ≥ 1 g/dL on serum protein electrophoresis (SPEP) or ≥ 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis (UPEP) or involved FLC ≥ mg/dL (≥ 100 mg/L) which must be obtained within 4 weeks prior to registration Serum and urine M-protein levels should be determined by electrophoresis rather than by quantitative immunoglobulin (Ig) measurement. Exceptions are made in cases in which the M-spike value may be deemed to be unreliable ( e.g. co-migrating M-spike). In these cases, quantitative Ig should be used. To assess response and progression, however, SPEP values should only be compared to SPEP values and quantitative Ig values only to quantitative Ig values Patients must have received at least two prior anti-MM treatments. The prior treatments must at least one IMiD (thalidomide or lenalidomide) and bortezomib. If patients are unable to tolerate thalidomide or lenalidomide they can be included without prior IMiD treatment. Patients may be included if they did not experience grade III neuropathy while on bortezomib. Patients may have previously received autologous or peripheral blood stem cell transplantation Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. Exception: e.g. kyphoplasty, vertebroplasty, local radiation therapy for symptomatic bone lesions (e.g., uncontrolled pain or high risk of pathologic fracture) Age ≥ 18 years Life expectancy of greater than 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%; see Appendix B) Patients must have adequate organ and marrow function as defined below, obtained within 4 weeks prior to registration Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to entering the study or those who have not recovered from AEs due to chemotherapy, radiotherapy, or major surgery completed more than 4 weeks prior to registration. Exception: local radiation therapy for symptomatic bone lesions (e.g., uncontrolled pain or high risk of pathologic fracture) Patients with any of the following cardiac abnormalities QTcF at screening > 450 msec History of syncope or family history of idiopathic sudden death Sustained or clinically significant cardiac arrhythmias Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure Concomitant medication(s) known to increase the QT interval Diabetic patients on antidiabetic medications whose HbA1C > 8% Patients currently receiving high dose systemic steroids for treatment of MM, patients without prior bortezomib treatment, patients who received an investigational agent within 5 half lives of the agent | 2 |
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. | eligible ages (years): 18.0-70.0, HIV-Associated Lipodystrophy Syndrome HIV facial lipoatrophy concurrent antiretrovirals known psychological disorder skin allergies significant medical problems precluding anaesthesia | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Disease-related: 1. Have a diagnosis of MM based on standard 2. Currently has MM with measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 gm/dL and/or urine monoclonal immunoglobulin amount of at least 200 mg/24 hours. 3. Have relapsed within 12 weeks of receiving or is refractory to their most recent bortezomib-containing regimen as long as they meet the following Progressed from bortezomib-containing regimen either as a single agent or in combination with an alkylating agent (melphalan or cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin), IMiDs (thalidomide or lenalidomide), and/or a glucocorticosteroid (prednisone, dexamethasone or medrol) Bortezomib must have been administered at 4 doses of a minimum of 1.0 mg/m2 in no more than 28 days per cycle. Subjects must have received at least one cycle meeting this definition and have shown progressive disease to be considered eligible Subject who have been refractory to their most recent bortezomib-containing regimen are eligible regardless of when the subject received that regimen, as long as they meet the above and have been off the treatment for > 3 weeks. Definition of refractory disease: patients who meet for progressive disease while currently receiving treatment. Demographics: 4. Age ≥ 18 years 5. Life expectancy ≥ 3 months 6. ECOG performance status 0-2 at study entry Laboratory tests (within 14 days prior to drug dosing on Cycle 1, Day 1) 7. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; if the bone marrow is extensively infiltrated (> 70% plasma cells) then 1.0 x 109/L 8. Hemoglobin ≥ 8 g/dL (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines) 9. Platelet count ≥ 75 × 109/L; if the bone marrow is extensively infiltrated (> 70% plasma cells) then 50 x 10^9/L 10. Creatinine clearance (CrCl) ≥ 30 mL/minute either measured or calculated. Subject with a creatinine > 15mL/min and < 30 mL/min due to significant myelomatous involvement of the kidneys may be enrolled in the study after receipt of approval from Oncotherapeutics. 11. Adequate hepatic function, with AST (SGOT) and ALT (SGPT) 3 x upper limit of normal (ULN) or 5 x ULN if hepatic metastases are present and serum total bilirubin ≤ 1.5 x ULN 12. Serum potassium > 3 and < 5 Ethical/Other 13. Written informed consent in accordance with federal, local, and institutional guidelines. 14. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception. 15. Male subjects must agree to practice contraception. Disease-related 1. Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome 2. Plasma cell leukemia 3. Severe hypercalcemia, i.e., serum calcium 12 mg/dL (3.0 mmol/L) corrected for albumin 4. Received the following prior therapy Chemotherapy within 21 days of enrollment (6 wks for nitrosoureas) Corticosteroids (>10 mg/day prednisone or equivalent) within 21 days of enrollment Immunotherapy or antibody therapy as well as thalidomide, lenalidomide, arsenic trioxide, or bortezomib within 21 days before enrollment Radiation therapy within 21 days before enrollment, receipt of localized radiation therapy does not preclude enrollment Use of any other experimental drug or therapy within 28 days of enrollment Concurrent Conditions 5. Impaired cardiac function or clinically significant cardiac diseases, including any one of the following Unstable angina or myocardial infarction within 4 months prior to enrollment | 1 |
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. | eligible ages (years): 18.0-90.0, Acute Myeloid Leukemia AML relapse within one year after transplantation Blood and marrow sampling being possible Expected survival at least 4 weeks No expected drug interactions Informed consent possible Intolerance to any study drug Serious kidney or liver disease Informed consent not possible Previous pancreatitis | 0 |
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. | eligible ages (years): 18.0-999.0, Plasma Cell Leukemia Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Confirmed relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL); patients should have received at least 1 prior treatment regimen; prior treatment must have included at least one full cycle of a proteasome inhibitor (e.g., bortezomib) and at least one full cycle of an immunomodulatory (IMiD) (e.g., thalidomide, lenalidomide or pomalidomide); patients who have had prior ARRY-520 and carfilzomib will be allowed in the dose escalation phase, however prior ARRY-520 and carfilzomib will be excluded in the dose expansion cohort 1 of part A; there will be 2 cohorts in the dose expansion of part A: cohort 1 will be patients who are carfilzomib sensitive; cohort 2 will be patients who are carfilzomib refractory Part B: For Part B dose-expansion: once a MTD has been established in part A, additional dose escalation will occur with subsequent dose escalation of carfilzomib; during the dose escalation of part B, patient (pt) must have at least 1 line of prior therapy and no limitations on prior therapy; patients who had prior clinical benefit/response to ARRY-520 or carfilzomib with a stable disease (SD) or better may be eligible for dose expansion of part B; dose expansion of part B will be patients who are carfilzomib sensitive Measurable MM disease, defined as one of the following A monoclonal immunoglobulin (Ig) concentration on serum electrophoresis of >= 0.5 g/dL for an IgG myeloma, >= 0.1 g/dL for an IgD myeloma or 0.5 g/dL for an IgA myeloma Measurable urinary light chain secretion by quantitative analysis of >= 200 mg/24 hours Involved serum free light chain (FLC) level >= 10 mg/dL, provided the serum FLC ratio is abnormal Patients with oligo or non-secretory disease must have bone marrow involvement with at least 30% plasmacytosis Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 Absolute neutrophil count (ANC) >= 1.5 x 10^9/L Primary amyloidosis Treatment with an investigational product or device within 21 days of cycle 1 day 1 History of allergic reaction/hypersensitivity to any of the study medications, their analogues or excipients in the various formulations Cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1 Radiotherapy within 21 days prior to cycle 1 day 1; however, if the radiation portal covered =< 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy Major surgery within 14 days and minor surgery within 7 days prior to cycle 1 day 1 Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to cycle 1 day 1 Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study or, in the judgment of the investigator, would make the patient inappropriate for study participation Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment | 2 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Participant population is multiple myeloma patients over the age of 18 who are undergoing a scheduled bone marrow collection and/or blood drawing procedure as part of their routine treatment or follow up, and healthy volunteers over the age of 18 who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient Patients, who in the opinion of their physician, would be adversely affected by removal of an extra15ml of blood and /or an extra 10ml of bone marrow | 0 |
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. | eligible ages (years): 18.0-80.0, Amyloidosis medically diagnosed with systemic amyloidosis AST,ALT, alkaline phosphatase <= 3xULN and bilirubin ,1.5xULN undergone radio-labelled-SAP scanning as part of their routine clinical care male or female between 18 and 80 years of age inclusive, at time of signing the informed consent subject is ambulant and capable of attending CUC capable of giving written consent, which includes compliance with the requirements of the requirement and restrictions listed in the consent form a female subjects is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea male subjects with female partners of child-bearing potential must agree to use contraception methods listed in the protocol and informed consent information. This must be followed from the time of the first dose of study medication to 85 days post-last dose smokers (<10 cigarettes a day) are permitted but must be willing to abstain for the duration of residential study sessions a positive pre-study Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening the subject has participated in a clinical trial and has received an investigational therapeutic product (unlicensed) within 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing lactating females unwillingness or inability to follow the procedures outlined in the protocol subject is mentally or legally incapacitated renal failure requiring haemodialysis will normally result in exclusion. Subjects in patient group 4 on haemodyalysis may be considered providing their schedule of dialysis can be accommodated within the study schedule decompensated cardiac failure or recent history of syncope clinically significant anaemia Hb<9g/dL | 0 |
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. | eligible ages (years): 21.0-90.0, AL Amyloidosis Confirmed diagnosis of AL Amyloidosis New York Heart Association class IV patient on renal dialysis serum antibodies to mouse protein | 0 |
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. | eligible ages (years): 18.0-75.0, Multiple Myeloma Age ≥18 and < than or = to 75 Histologic and serologic findings, reviewed at MSKCC, confirming the diagnosis of multiple myeloma. Standard diagnostic for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines (Durie et al, 2003) Patients must have symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease) Patients who are receiving high-dose melphalan and ASCT as part of their initial therapy require at least minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008) Patients who are receiving high-dose melphalan and ASCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008) There is no limit on the number of prior regimens received by the patient Patients must have at least 7 x 10^6 (+/ 5 x 10^6) CD34+ stem cells/kg frozen if he/she is being treated as part of a salvage (second) transplant strategy; patients must have 10 x 10^6 (+/ 5 x 10^6) CD34+ stem cells/kg frozen if ASCT is being performed as part of initial therapy Adequate organ function is required, defined as follows Unstable angina or myocardial infarction within 4 months of initiating therapy on trial, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker Pregnant or lactating females Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas Contraindication to melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial | 2 |
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. | eligible ages (years): 18.0-65.0, Multiple Myeloma Patients aged 18 to 65 years Multiple Myeloma in 2nd or 3rd complete or partial response* Disease never refractory to lenalidomide Lenalidomide treatment ≤ 9 months HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high resolution level or HLA-DQ high or low resolution level) Insured under Social Security Information and consent signed Stable or progressive disease Hypersensitivity to lenalidomide or excipients Lenalidomide treatment > 9 months Absence of efficient contraception in women or men Cardiac insufficiency (ejection fraction < 50% by echocardiography) Pulmonary disease characterized by DLCO < 60% Severe renal insufficiency (clearance of creatinin < 30 ml/min) Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin > 2 times the upper normal value except in case of Gilbert's disease Bacterial, Viral or Fungal uncontrolled infections No contraceptive method for Female subjects of childbearing potential | 0 |
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. | eligible ages (years): 0.0-999.0, Multiple Myeloma diagnosis of multiple myeloma abnormal serum free light chains medical needs of anti-myeloma therapy receiving standard anti-myeloma therapy dialysis normal serum free light chains dementia | 0 |
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. | eligible ages (years): 18.0-999.0, Hyponatremia of Multiple Myeloma patients with multiple myeloma | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients who are being considered for autologous stem cell transplant as part of their routine care who have failed at least one prior attempt at stem cell mobilization with any of currently available standard regimens using growth factors Patients in who the use of Mozobil® is medically justified but is not possible because of insurance or financial reasons Patients scheduled to begin standard growth factor treatment with Neupogen® as part of routine care Patients who have had a bone marrow evaluation performed within one month prior to enrollment as part of routine clinical care or under IRB# 02815 Patients who have had a chest x-ray or CT Chest within 60 days prior to enrollment ECOG performance status ≤ 3 performed within 60 days prior to enrollment which will be determined by history Patients who are at least 18 years of age at the time of registration Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis within 60 days prior to enrollment History of New York Heart Association (NYHA) Class III or Class IV heart failure Recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias from medical history Untreated pneumothorax from medical history Uncontrolled seizure disorder from medical history Uncontrolled insulin dependent diabetes (verified by routine labs in medical record) History of severe claustrophobia Severe COPD (FEV1 < 50% of predicted on pulmonary function test) performed within 60 days prior to enrollment Untreated ear barotraumas from medical history Pregnancy or currently breastfeeding (females of childbearing potential must agree to use adequate contraception during the study). A urine pregnancy test will be performed prior to initiating HBOT | 2 |
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. | eligible ages (years): 18.0-69.0, Multiple Myeloma Diagnosis of multiple myeloma Have a suitable related or unrelated donor Age ≥18 but <70 yrs KPS of ≥70% Recovery from complications of previous therapies Diagnosis other than multiple myeloma Chemotherapy or radiotherapy within 21 days of initiating treatment in this study Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study Uncontrolled bacterial, viral, fungal or parasitic infections Uncontrolled CNS metastases Known amyloid deposition in heart Organ dysfunction LVEF <40% or cardiac failure not responsive to therapy FVC, FEV1, or DLCO <50% of predicted and/or receiving supplementary continuous oxygen Evidence of hepatic synthetic dysfunction, or total bilirubin >2x or AST >3x ULN | 1 |
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. | eligible ages (years): 18.0-99.0, Hodgkin Disease Hodgkin Lymphoma 1.1.1 All patients must have a pathologically confirmed diagnosis of classical Hodgkin's lymphoma (HL) as outlined in the World Health Organization (WHO) Classification System of Lymphoid Tumours. Patients with nodular lymphocyte-predominant Hodgkin's lymphoma (HL) (NLPHL) are not eligible. 2.1.1.2 Refractory or relapsed HL patients that are also candidates for auto stem cell transplant (ASCT). 2.1.1.3 At least one adverse prognostic factor: (1) initial relapse less than or equal to 12 months after primary chemotherapy, (2) staged as Ann Arbor Classification initial stage III or IV disease, (3) chemotherapy resistant disease, (4) Failure to achieve a complete response (CR) with cytoreductive chemotherapy or persistent positive (18) fluorodeoxyglucose positron emission tomography (FDGPET) imaging. 2.1.1.4 At least 10% of the cells obtained from lymph node, or extranodal sites must react with anti-cluster of differentiation 25 (CD25) (anti-Tac) on immunofluorescent or immunoperoxidase staining. Because of the high frequency of CD25 positivity of the infiltrating Tcells in HL tumors, patients with CD25-positive infiltrating T cells will be eligible even if their Hodgkin's (Reed-Sternberg) cells are CD25-negative. 2.1.1.5 Measurable disease as defined by the Cheson Response for Malignant Lymphoma detailed in section 6.2 with at least one lesion greater than or equal to 1.0 cm in longest diameter by computed tomography (CT) scan. 2.1.1.6 Omission of cytotoxic chemotherapy or other systemic therapy of the malignancy for greater than or equal to 4 weeks prior to entry into the trial. Patients must be greater than or equal to 4 weeks since major surgery, radiotherapy, or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to less than or equal to CTC grade 1, exclusive of grade 2 alopecia, fatigue, lymphopenia, cluster of differentiation 4 (CD4)+ circulating T cells, white blood cell (WBC) or bilirubin. 2.1.1.7 Patients must be greater than or equal to 18-years old. 2.1.1.8 Patients must have a life expectancy of greater than 3 months. 2.1.1.9 Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1. 2.1.1.10 The patient must have a granulocyte count of at least 1,500/microL and a platelet count of greater than 100,000/microL. 2.1.1.11 Patients must have a creatinine of less than 2.0 mg/dL, or if the patient has a serum creatinine greater than or equal to 2.0, a measured creatinine clearance (Ccr) must be greater than 60 mL/min/1.73m(2). 2.1.1.12 Patients must have a serum alkaline phosphatase, alanine aminotransferase (ALT) serum glutamic oxaloacetic transaminase (SGOT), and aspartate aminotransferase (AST) serum glutamic pyruvic transaminase (SGPT) less than 3 times the upper limit of normal (ULN), unless due to liver or bone involvement by HL. Under these circumstances, serum alkaline phosphatase, SGPT and SGOT must be less than 5 times ULN. 2.1.1.13 Patients must have a total serum bilirubin less than 2.5 times ULN. 2.1.1.14 Patients must have a cardiac ejection fraction greater than 45% on 2D echocardiography or multi-gated acquisition scan (MUGA) obtained within 28 days of study enrollment. 2.1.1.15 Lung diffusion capacity for carbon monoxide (DLCO) greater than 50%, or forced expiratory volume at 1.0 seconds (FEV1.0) greater than 65% of predicted on pulmonary function testing (PFT) obtained within 28 days of study enrollment. 2.1.1.16 Women of childbearing potential must have a negative serum Beta-human chorionic gonadotropin (HCG) pregnancy test at initial screening and within 3 days prior to registration. 2.1.1.17 The effects of (90)Y-daclizumab on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, while receiving treatment and for 4 months after undergoing ASCT. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 2.1.1.18 Patients receiving a stable dose (greater than 4 weeks) of corticosteroid therapy equivalent to 20 mg of prednisone per day or less are eligible. 2.1.1.19 Patients must be able to understand and sign informed consent 1.2.1 Patients who have relapsed from their initial Adriamycin, bleomycin, vinblastine, dacarbazine) ABVD or similar standard treatment regimen and have not received any other chemotherapy or salvage systemic treatment. 2.1.2.2 Patients that have received prior radioimmunotherapy. 2.1.2.2. Patients enrolled on another therapeutic study. 2.1.2.3 Patients that have received prior radioimmunotherapy. 2.1.2.4 Patients that have received a prior autologous or allogeneic stem cell transplant 2.1.2.5.Patients that have received prior radiation to the lung, excluding prior mediastinal radiation. 2.1.2.6 Patients with greater than 25% involvement of the bone marrow with HL. 2.1.2.7 Patients with evidence of myelodysplasia, leukemia by morphology, immunostains flow cytometry or abnormal cytogenetics on a bone marrow aspirate or biopsy. The diagnosis of myelodysplasia will be made by an independent investigator of the Laboratory of Pathology, National Cancer Institute (NCI) taking into consideration the totality of the clinical, pathological, flow cytometric and cytogenetic information described in Appendix E and present in a particular individual s evaluation. 2.1.2.8 Patients with history of central nervous system (CNS) involvement or active CNS involvement by malignancy. 2.1.2.9 Patients with an active second primary cancer will not be eligible. Patients curatively treated for a second cancer greater than 5 years prior to enrollment without a recurrence are eligible. Patients curatively treated for a second primary cancer within the last 5 years with a less than or equal to 5% risk of recurrence are eligible. Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine cervix will be allowed on study. 2.1.2.10 Patients with serum human anti-human antibody (HAHA) against daclizumab. 2.1.2.11 Patients with human immunodeficiency virus (HIV) infection (antibody positive with positive confirmatory molecular test). 2.1.2.2 Patients who have chronic hepatitis B or hepatitis C. 2.1.2.13 Patients with an uncontrolled serious infection. 2.1.2.14 Pregnant or breastfeeding women. 2.1.2.15 Patients with significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure (BP) greater than 115 mmHg), unstable angina, congestive heart failure (greater than New York Heart Association (NYHA) class II), poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty or myocardial infarction within the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmias. 2.1.2.16 Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol and the required follow up. 2.1.2.17 at the discretion of the principal investigator (PI) or delegate if participation to the study is deemed too risky (e.g. clinically significant pleural or pericardial effusion or ascites with possibly increased radio-toxicity) | 0 |
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. | eligible ages (years): 60.0-999.0, Acute Myeloid Leukemia Patients who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study Patients who are capable of giving informed consent Patients failed to discontinue the Study 311-10-001 even though patients met the discontinuation criteria Patients who have participated in any other clinical trials , excluding the Study 311-10-001) | 0 |
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. | eligible ages (years): 18.0-999.0, Ovarian Carcinoma Relapse ovarian carcinoma relapse neurotoxicity grade III renal clearance < 60 ml/min | 0 |
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. | eligible ages (years): 20.0-90.0, Arteriovenous Fistula Age is more than 20 year-old. 2. End-stage renal disease with regular hemodialysis for more than one year AVF/ AV graft is not located in upper arm | 0 |
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. | eligible ages (years): 20.0-70.0, Delayed Function of Renal Transplant Primary Nonfunction of Renal Transplant Acute Rejection of Renal Transplant Subjects must have end-stage renal disease, have been on one renal replacement therapy (hemodialysis or peritoneal dialysis) for > 6 months ( Who had been on hemodialysis for at least 6 months before renal transplant for the hemodialysis group; Who had been on peritoneal dialysis for at least 6 months before renal transplant for the peritoneal dialysis group ), and are scheduled to receive a first kidney transplant from a deceased donor, a living-related donor, or a living-unrelated donor. 2. Between the ages of 20 and 70 years, inclusive. 3. Either female or male adults 4. Subjects must be willing and able to provide written personal information consent with evidence of a personally signed and dated personal information consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study Subjects who had combined dialysis (hemodialysis + peritoneal dialysis simultaneously). 2. Subjects who are recipients for multiple organ transplant. 3. Subjects scheduled for non-heart beating donor transplantation. 4. Subjects scheduled for transplantation using desensitization (plasmapheresis + Rituximab) process. 5. Subjects with evidence of active infection. 6. Women of childbearing potential who are either pregnant, lactating, planning to become pregnant in the next 12 months. Women of childbearing potential must be willing to agree to contraceptive practices | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma > 65 years old and non candidate for autologous stem cell transplant Patient must be newly diagnosed with Multiple Myeloma according to establish symptoms. Steroid pulses administration are allowed for any required emergency prior to starting induction therapy or bisphosphonates administration Patient must have measurable disease, defined as follows: for secretory multiple myeloma, measurable disease is defined by the presence of measurable monoclonal component in serum or in urine excretion if light chain is greater than or equal to 200 mg/24 hours(Annex 5) Measured ECOG < 2 state level The patient must have a life expectancy greater than 3 months Adequate laboratory values prior to induction treatment initiation, defined as follow: 1. Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g / dl and absolute neutrophil count ≥ 1000/mm3. Lower values are permitted if they are due to BM infiltration. 2. Corrected serum calcium ≤ 14mg/dl. 3. Aspartate transaminase (AST): ≤ 2.5 x normal upper limit. 4. Alanine transaminase (ALT):): ≤ 2.5 x normal upper limit. 5. Total bilirubin: ≤ 1.5 x normal upper limit. 6. Serum creatinine ≤ 2 mg / dl Men (including vasectomy done) must use barrier contraception (latex condoms) when having sex with women of potential childbearing, and for at least four weeks after thalidomide last dose Non-secretory MM Previous treatment for multiple myeloma with the exception of steroid pulses for any emergency that requires treatment before beginning the induction, administration of bisphosphonates or radiation therapy Basal peripheral neuropathy higher than grade 2 within 14 days of inclusion Known thalidomide hypersensitivity Use of any investigational agent within 30 days prior to their inclusion Known human immunodeficiency virus(HIV) infection, detectable surface antigen of hepatitis B or active infection by the hepatitis C viruses Myocardial infarction within 6 months prior to or heart functional class III or IV according to New York Heart Association (NYHA) heart failure, angina, uncontrolled ventricular arrhythmias or acute ischemia detected by electrocardiogram or conduction system abnormalities Participation in another clinical trial or receiving any investigational agent | 1 |
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. | eligible ages (years): 18.0-80.0, Multiple Myeloma Participants must have had a diagnosis of symptomatic MM, MM + amyloidosis, or POEMS (osteosclerotic myeloma: Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes) requiring treatment. Participants with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy. Note that study participants do not need to have active disease at the time of study entry, as participants may have received up to 12 months of prior chemotherapy, which might have induced a response. 2. Protein must be present (quantifiable M-component of IgG, IgA, IgD, or IgE and/or urinary kappa or lambda light chain, Bence-Jones protein, or Free Kappa Light Chain or Free Lambda Light Chain) in order to evaluate response. Non-secretory participants are eligible provided the participant has > 20% plasmacytosis OR multiple (>3) focal plasmacytomas or focal lesions on MRI. 3. Participants must have received no more than 12 months of prior chemotherapy for this disease. Participants may have received prior radiotherapy provided approval has been obtained from the PI. 4. Participants must not have had a prior transplant. 5. Participants must be 18-80 years of age at the time of study entry. 6. Ejection fraction by ECHO or MUGA of ≥ 40% performed. 7. Participants must have adequate pulmonary function studies, > 50% of predicted on mechanical aspects (FEV1, FVC) and diffusion capacity (DLCO) > 50% of predicted (adjusted for hemoglobin). If the participant is unable to complete pulmonary function tests due to disease related pain or condition, a participant may still be enrolled provided that the PI or enrolling investigator documents that the participant is a transplant candidate. 8. Participants must have a creatinine < 3 mg/dl and a calculated creatinine clearance >30mL/min. The Cockroft-Gault equation may be used to obtain calculated creatinine clearance. 9. Participants must have a performance status of 0-2 based on ECOG criteria. Participants with a poor performance status (3-4)based solely on bone pain will be eligible, provided there is documentation to verify this. 10. Participants must sign the most current IRB-approved study ICF (Informed Consent Form) Prior autologous or allogeneic transplant. 2. Platelet count < 30 x 109/L, unless myeloma-related. If MM-related, the enrolling investigator must document this. 3. > grade 3 neuropathy. 4. Known hypersensitivity to bortezomib, boron, or mannitol. 5. Uncontrolled diabetes. 6. Recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias. 7. Participants must not have light chain deposition disease-related renal failure or creatinine >3 mg/dl. 8. Participants must not have a concurrent malignancy unless it can be adequately treated by surgical, non-chemotherapeutic intervention. Participants may have a history of prior malignancy, provided that he/she has not had any treatment within 365 days of study entry AND that life expectancy exceeds 5 years at the time of study entry. 9. Participants must not have life-threatening co-morbidities. 10. Women of child-bearing potential must have a documented negative pregnancy test documented within one week of study entry. Women and men of reproductive potential may not participate unless they have agreed, by signing the study ICF, to use effective contraceptive method(s) as outlined in that form | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Aged 18 years or greater Newly diagnosed as having symptomatic multiple myeloma or non-secretory multiple myeloma Provide written informed consent Women of childbearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use contraception in accordance with (and consent to) the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention, or commit to absolute and continuous abstinence Women of child bearing potential must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention Asymptomatic myeloma Solitary plasmacytoma of bone. (Patients with previous solitary plasmacytoma now progressed to symptomatic or non-secretory myeloma are eligible) Extramedullary plasmacytoma (without evidence of myeloma) Previous (<5 years since diagnosis) or concurrent active malignancies, except surgically-removed basal or squamous cell carcinoma of the skin, treated carcinoma in situ of the breast or cervix, or incidental histologic finding of prostate cancer (TMN stage of T1a or 1b). Patients with remote histories (>5 years) of other cured malignancies may be entered Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) for high-risk disease Previous treatment for myeloma, except the following: local radiotherapy to relieve bone pain or spinal cord compression; or prior bisphosphonate treatment; or corticosteroids within the last 3 months Known history of allergy contributable to compounds containing boron or mannitol Grade 2 or greater (NCI criteria) peripheral neuropathy Acute renal failure (unresponsive to up to 72 hours of rehydration, characterised by creatinine >500µmol/L or urine output <400 mL/day or requirement for dialysis) Lactating or breastfeeding | 1 |
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. | eligible ages (years): 18.0-999.0, Heart Failure Patients ages 18 and older Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery Patients who are pacemaker dependent children, human fetuses, neonates prisoners will not be included Pregnant women will not be included | 0 |
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. | eligible ages (years): 21.0-999.0, Stage 5 Chronic Kidney Disease Hemodialysis Peritoneal Dialysis All chronic HD and PD patients who are on regular follow-up with nephrologists in the NUH outpatient renal or PD clinic, and who meet the following will be included in the study: male or female 21 years of age or older, with stage 5 CKD (eGFR <15 ml/min/1.73m2) and have been receiving HD or PD for at least 3 months Transient dialysis patients, those have poor cognitive function or are not able to complete the questionnaires or give informed consent | 0 |
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. | eligible ages (years): 18.0-75.0, Accelerated Phase Chronic Myelogenous Leukemia 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 Acute Promyelocytic Leukemia (M3) Adult Nasal Type Extranodal NK/T-cell Lymphoma Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma Anaplastic Large Cell Lymphoma B-cell Adult Acute Lymphoblastic Leukemia Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Phase Chronic Myelogenous Leukemia Contiguous Stage II Adult Burkitt Lymphoma Contiguous Stage II Adult Diffuse Large Cell Lymphoma Contiguous Stage II Adult Lymphoblastic Lymphoma Contiguous Stage II Grade 1 Follicular Lymphoma Contiguous Stage II Grade 2 Follicular Lymphoma Contiguous Stage II Grade 3 Follicular Lymphoma Contiguous Stage II Mantle Cell Lymphoma Contiguous Stage II Small Lymphocytic Lymphoma Cytomegalovirus Infection de Novo Myelodysplastic Syndromes Essential Thrombocythemia Extramedullary Plasmacytoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Isolated Plasmacytoma of Bone Monoclonal Gammopathy of Undetermined Significance Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse 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 Small Lymphocytic Lymphoma Peripheral T-cell Lymphoma Polycythemia Vera Post-transplant Lymphoproliferative Disorder Previously Treated Myelodysplastic Syndromes Primary Central Nervous System Hodgkin Lymphoma Primary Central Nervous System Non-Hodgkin Lymphoma Primary Myelofibrosis Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/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 Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Stage I Adult Burkitt Lymphoma Stage I Adult Diffuse Large Cell Lymphoma Stage I Adult Hodgkin Lymphoma Stage I Adult Lymphoblastic Lymphoma Stage I Adult T-cell Leukemia/Lymphoma Stage I Chronic Lymphocytic Leukemia Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage I Grade 1 Follicular Lymphoma Stage I Grade 2 Follicular Lymphoma Stage I Grade 3 Follicular Lymphoma Stage I Mantle Cell Lymphoma Stage I Multiple Myeloma Stage I Small Lymphocytic Lymphoma Stage IA Mycosis Fungoides/Sezary Syndrome Stage IB Mycosis Fungoides/Sezary Syndrome Stage II Adult Hodgkin Lymphoma Stage II Adult T-cell Leukemia/Lymphoma Stage II Chronic Lymphocytic Leukemia Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage II Multiple Myeloma Stage IIA Mycosis Fungoides/Sezary Syndrome Stage IIB Mycosis Fungoides/Sezary Syndrome Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Hodgkin Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Adult T-cell Leukemia/Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Cutaneous T-cell Non-Hodgkin 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 Multiple Myeloma Stage III Small Lymphocytic Lymphoma Stage IIIA Mycosis Fungoides/Sezary Syndrome Stage IIIB Mycosis Fungoides/Sezary Syndrome Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Adult T-cell Leukemia/Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Cutaneous T-cell Non-Hodgkin 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 Small Lymphocytic Lymphoma Stage IVA Mycosis Fungoides/Sezary Syndrome Stage IVB Mycosis Fungoides/Sezary Syndrome T-cell Adult Acute Lymphoblastic Leukemia T-cell Large Granular Lymphocyte Leukemia Untreated Adult Acute Myeloid Leukemia Untreated Hairy Cell Leukemia Waldenström Macroglobulinemia HLA A*0201 subtype CMV seropositive Able and willing to sign the informed consent form (ICF) Willingness to be followed for the planned duration of the trial (6 months post-HCT) Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) Planned related or unrelated HCT, with 8/8 or 7/8 (A, B, C, DRB1) high resolution HLA donor allele matching HCT for the treatment of hematologic cancers including, but not limited to Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in hematologic remission by bone marrow/peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed) Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase Hodgkin and non-Hodgkin lymphoma A poor-risk patient, as defined by any of the following Chronic myelogenous leukemia in blast crisis Acute myeloid leukemia beyond second remission Multiple myeloma Aplastic anemia Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting agent In vitro T cell depleted graft Planned prophylactic therapy with CMV immunoglobulin Planned CMV prophylactic therapy Experimental anti-CMV chemotherapy in the last 6 months | 0 |
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. | eligible ages (years): 0.0-75.0, Leukemia Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders Acute Leukemia Myelodysplastic syndrome Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous leukemia) Non Hodgkins Lymphoma Hodgkins Disease Multiple Myeloma Age includes from birth to < 75 years old Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status > 70% Patients must have adequate organ function measured by Female patients who are pregnant or breast-feeding Active viral, bacterial or fungal infection Patient seropositive for HIV-I/II; HTLV -I/II Presence of leukemia in the CNS Candidate for a protocol of higher priority. For the purpose of this study, the following protocols will be considered of higher priority: 10-051 Donor HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts) Meets outlined in the FACT-approved SOP for "DONOR AND FOR in the Blood and Marrow Transplant Program Manual, document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter Wt >25kg Donor Evidence of active infection (including urinary tract infection, or upper respiratory tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative | 0 |
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. | eligible ages (years): 21.0-999.0, Multiple Myeloma All Patients fulfilling IMWG diagnostic for myeloma Unable to take consent | 2 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with Multiple Myeloma, developing engraftment syndrome Patients with Multiple Myeloma, with no features of engraftment syndrome | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patient must have a histologically confirmed diagnosis of multiple myeloma Patient must have received a prior autologous stem cell transplantation with melphalan conditioning for multiple myeloma with subsequent disease progression and repeat autologous stem cell transplantation is deemed appropriate by the treating physicians Patient must receive induction chemotherapy including 2 to 4 cycles of anti-myeloma therapy including bortezomib, with or without immune modulating agents and/or corticosteroids, Completion of induction therapy will occur within 30 days of first study drug dose Patient must have ≥ 2x106/kg CD34+ autologous stem cells available for transplantation Patient must be ≥ 18 years of age Patient must have life expectancy of greater than 6 months Patient must have an ECOG performance status ≤ 2 or Karnofsky performance status ≥ 60% (see Appendices A and B) Patient must have normal bone marrow and organ function as defined below within 14 days prior to first study drug dose (conditioning regimen) Absolute neutrophil count ≥500/mm3 Platelets ≥ 50,000/mm3 Patient must not be refractory to induction therapy. Refractory is defined as disease progression while on therapy or within 30 days following completion of therapy Patient must not have had disease progression requiring active treatment within 12 months of previous autologous stem cell transplant. Maintenance therapy is not considered active treatment Patient must not have peripheral neuropathy ≥ grade 3 based on NCI CTCAE v 4.0 (Appendix D) Patient must not be receiving renal replacement therapy, hemodialysis, or peritoneal dialysis Patient must not have another concurrent malignancy requiring treatment Patient must not be receiving any other investigational agents within 14 days prior to the first dose of study drug Patient must not have known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, carmustine, etoposide, cytarabine, and melphalan, or other agents used in the study Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patient must not be pregnant and/or breastfeeding. of Women and Minorities -Both men and women and members of all races and ethnic groups are eligible for this trial | 1 |
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. | eligible ages (years): 19.0-89.0, Myocardial Ischemia Under an Institutional Committee on Human Research board approved protocol, 20 patients with a suspected myocardial ischemic disease with positive stress nuclear medicine test laboratory will be recruited in this prospective study. All subjects will be screened for GFR within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be included in the study. All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of < 30mL/min will not be selected for the study to avoid NSF Age 18 to 89 years; 2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc); 3. Claustrophobia; 4. Inability to perform an adequate breath-hold for imaging, 5. Inability to provide informed consent; 6. all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR < 60 ml/min will be excluded; 7. Pregnant and lactating women; 8. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin; 10) Contra indication for Regadenoson 1. 2nd or 3rd-degree AV block (except in patients with a functioning artificial pacemaker) 2. Sinus node disease (except in patients with a functioning artificial pacemaker) 3. Unstable angina 4. Acute myocardial infarction 5. Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) 6. Hypersensitivity to adenosine 7. Caffeine within 12-24 hours 8. Theophylline and Dipyridamole products within 24 hours | 0 |
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. | eligible ages (years): 18.0-99.0, Multiple Myeloma Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma confirmed by the Laboratory of Pathology, NCI based on the International Myeloma Working Group Serum M-protein greater than or equal to 3 g/dl and/or bone marrow plasma cells greater than or equal to 10 % Absence of anemia: Hemoglobin >10 g/dl Absence of renal failure: calculated creatinine clearance (according to MDRD) > 80 ml/min (or alternatively based on standard creatinine level of 2 mg/dl) Absence of hypercalcemia: Ca < 10.5 mg/dl or less than or equal to 2.5 mmol/L Absence of lytic bone lesion High-risk SMM per Mayo Clinic2 or Spanish Measurable disease within the past 4 weeks defined by any one of the following Serum monoclonal protein greater than or equal to 1.0 g/dl Urine monoclonal protein >200 mg/24 hour Patients who are receiving any other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial Prior therapy for SMM with a proteasome inhibitor Patients with a diagnosis of MM Contraindication to any concomitant medication, including antivirals, anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent Uncontrolled hypertension or diabetes Pregnant or lactating females Has refractory GI disease with refractory nausea/vomiting, inflammatory bowel disease, or bowel resection that would prevent absorption Patient has greater than or equal to Grade 2 peripheral neuropathy Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months | 0 |
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. | eligible ages (years): 18.0-999.0, Newly Diagnosed Myeloma Patient Above 65 Years Old newly diagnosed MM age over 65 measurable disease Patients less than 65 and/or not proceeding to autologous PBSC transplantation | 1 |
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. | eligible ages (years): 18.0-99.0, Multiple Myeloma Patients with multiple myeloma treated with induction therapy or re-induction therapy, who at the time of study enrollment have documented evidence of stable disease response or better according to International Myeloma Workshop Consensus Panel. The response assessment must occur at least 4 weeks after completion of their last treatment Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of lenalidomide in patients Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Patient must have adequate hematologic, renal, hepatic, and cardiac function as defined by Absolute neutrophil count greater than or equal to 1.0 K/microL independent of growth factor support Platelets greater than or equal to 75K/microL Hemoglobin greater than or equal to 8 g/dL (transfusions are permissible) Calculated creatinine (CrCl) clearance of greater than or equal to 40 mL/min. using the Cockcroft-Gault method. If the calculated CrCl based on Cockcroft-Gault method is Total bilirubin less than or equal to 1.5 mg/dL, aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) less than or equal to 3 times ULN Females of childbearing potential (FCBP) must agree to use two effective forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of effective contraception must one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed Patients with progressive or refractory multiple myeloma (MM), as defined by International Myeloma Workshop Consensus Panel criteria Refractory to lenalidomide in the most recent line of therapy, as defined by the International Myeloma Consensus Panel as failure to achieve minimal response or development of progressive disease while on lenalidomide or within 30 days of lenalidomide therapy Patients who are receiving any other investigational agents with the intent to treat myeloma. Permitted concurrent therapies Bisphosphonates Radiotherapy to single stable disease site Plasma cell leukemia Pregnant or lactating females. Because there is a potential risk for adverse events to nursing infants secondary to treatment of the mother with lenalidomide, lactating females must agree not to breast feed while taking lenalidomide Uncontrolled hypertension or diabetes Active hepatitis B or C infection | 1 |
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. | eligible ages (years): 18.0-999.0, Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Histologically confirmed multiple myeloma Documented relapse or persistent disease after at least 1 prior therapy containing both bortezomib and lenalidomide; or at least 2 prior therapies containing bortezomib in one and lenalidomide in the other, or if intolerant of bortezomib and/or lenalidomide; prior autologous and allogeneic bone marrow transplantation are allowed Need for further treatment for myeloma, as determined by the patient's treating physician; this is defined as progression of clinical features (worsening anemia, renal function, bone disease, hypercalcemia, recurrent infections, and constitutional symptoms) OR biochemical progression (increasing M-spike in serum or urine, involved serum or urine free light chain over 2 consecutive time points greater than 4 weeks apart) Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Ability to understand and the willingness to sign a written informed consent document Birth control is required with full barrier contraceptives or complete abstinence for the duration of time receiving therapy and for 6 months after completing the last drug taken The need for further treatment: this is defined as progression of clinical features (worsening anemia, renal function, bone disease, hypercalcemia, recurrent infections, and constitutional symptoms) OR biochemical progression (increasing M-spike in serum or urine, involved serum or urine free light chain over 2 consecutive time points greater than 4 weeks apart) History of allergic reactions to compounds of similar chemical or biological composition to rapamycin or hydroxychloroquine Patients may not take any of the following medications while on study, but will be considered eligible if medication is discontinued at least 72 hours (hrs) prior to first dose of Rapamycin Carbamazepine Rifabutin Rifampin Rifapentine St. John's wort Clarithromycin Cyclosporine Diltiazem | 1 |
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. | eligible ages (years): 18.0-999.0, End Stage Renal Failure Neuropathic Pain All adult patients > 18 years old with end stage renal disease on dialysis and critical ischaemia defined as rest pain most days for >3 months Pre-dialysis Hypersensitivity to Qutenza, Emla or any of the excipients Broken skin or active ulceration at the site of application Severe uncontrolled hypertension (systolic BP >200) Proven cardiac event during the preceding 3 months Women who are pregnant or breast feeding Diabetic neuropathy resulting in a loss of sensation Lack of capacity or inability to provide informed consent Declines participation in the study | 0 |
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. | eligible ages (years): 60.0-999.0, Mild Cognitive Impairment Age ≥ 60 years Memory complaints No dementia (DSM-IV, negative) No depression (Geriatric Depression score ≤ 5/15) Ability to walk a distance of 15 meters unaided Diagnosis of MCI To have hypovitaminosis D (i.e. serum 25-hydroxyvitamin D [25OHD]concentration ≤ 30ng/mL) To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65mmol/L) To have given and signed an informed consent to participate in the trial To be affiliated to French Social Security Others cognitive disorders (untreated thyroid dysfunction, chronic ongoing ethylism, history of syphilis, stroke, severe depressive symptomatology (Geriatric Depression score > 5/15), existence of dementia according to DSM-IV and at the time of inclusion) Vitamin D supplementation during Contraindications to vitamin D Unstable medical condition Enrollment in another simultaneous clinical trial Civil defense measures underway | 0 |
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. | eligible ages (years): 18.0-999.0, Recurrent Plasma Cell Myeloma Serum creatinine =< 2.5 mg/dL Absolute neutrophil count >= 1000/uL Untransfused platelet count >= 75000/uL Hemoglobin >= 8 g/dL Total bilirubin =< 1.5 times institutional upper limit of normal (ULN) Patients with relapsed multiple myeloma who have already received one or more standard treatment regimens Measurable disease of multiple myeloma as defined by at least ONE of the following Serum monoclonal protein >= 1 g/dL >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis Serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio Any of the following recent therapies Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration Anthracyclines =< 14 days prior to registration High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (bortezomib) =< 7 days prior to registration Concomitant high dose corticosteroids (concurrent use of corticosteroids); patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis, etc Other active malignancy =< 2 years prior to registration; non-melanotic skin cancer or carcinoma in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer Any of the following Pregnant women or women of reproductive ability who are unwilling to use 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug Nursing women Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 30 days after stopping treatment | 2 |
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. | eligible ages (years): 18.0-999.0, Acute Myeloid Leukemia Diffuse Large B-cell Lymphoma Acute Lymphoblastic Leukemia Multiple Myeloma Histologically or cytologically proven acute leukemias (AML or ALL) or hematologic malignancies (DLBCL or MM) using standard diagnosis criteria. Acute leukemia includes de novo and secondary to a pre-existing myelodysplastic syndrome, according to the World Health Organization 2008 classification. For DLBCL, an archived formaldehyde-fixed paraffin-embedded block must be available Has failed all standard therapies or for whom standard treatments are contra-indicated Acute leukemia participants: <60 years old in second relapse or relapsing after allogeneic stem cell transplantation (aSCT) regardless of number of relapses; >60 years old in first relapse with a disease-free interval (DFI) <12 months or further relapse; irrespective of age, in participants relapsing after aSCT, the time elapsed since aSCT should be >90 days; participants with B-cell ALL: Philadelphia chromosome positive (Ph+) must have received ≥2 lines of therapy, including 2 bcr-abl tyrosine-kinase (TK) inhibitors (among imatinib, nilotinib and dasatinib), or only 1 line including 1 TK inhibitor, if the relapse/refractoriness is associated with the detection of a resistance mutation to these inhibitors DLBCL participants: Failed 2 standard lines of therapy (≥1 containing an anti-CD20 monoclonal antibody), or for whom such treatment is contra-indicated MM participants: Adequately exposed to at least one alkylating agent, one corticosteroid, one immunomodulatory drug (IMiD) and bortezomib, or for whom such treatments are contra-indicated For participants with evaluable disease Advanced leukemia participants must have >5% bone marrow blasts at study entry, without alternative causality (e.g. bone marrow regeneration) DLBCL participants must have ≥1 non-irradiated tumor mass ≥15 mm (long axis of lymph node) or ≥10 mm (short axis of lymph node or extranodal lesions) on spiral computed tomography (CT)-scan MM participants must have ≥1 of the following: serum monoclonal component >1 g/dL (IgG), or >0.5 g/dL (IgA), or Bence-Jones (BJ) proteinuria >200 mg/24h, or measurable plasmacytoma (not previously irradiated) Life expectancy ≥3 months History of prior malignancy other than those previously treated with a curative intent >3 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the DFI Pregnant or lactating women or women of childbearing potential not using adequate contraception. Male participants not using adequate contraception Peripheral cytopenias (i.e. auto-immune hemolytic anemia or thrombocytopenia) Acute promyelocytic leukemia or with clinically uncontrolled (i.e. with bleeding) disseminated intravascular coagulation (DIC) Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD Uncontrolled leptomeningeal disease Other tumor location necessitating an urgent therapeutic intervention (palliative care, surgery or radiation therapy), such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc Unable to swallow oral medications, or has gastrointestinal condition (e.g. malabsorption, resection) deemed to jeopardize intestinal absorption Other serious illness or medical conditions, which, in the investigator's opinion could hamper understanding of the study by the participants, participant's compliance to study treatment, participant's safety or interpretation of study results. These conditions (but are not restricted to): 1. Congestive heart failure or angina pectoris except if medically controlled. Previous history of myocardial infarction within 1 year of study entry, uncontrolled hypertension or arrhythmias. 2. Existence of significant neurologic or psychiatric disorders impairing the ability to obtain consent. 3. Uncontrolled infection. 4. Known human immunodeficiency virus (HIV) positivity Concurrent treatment with other experimental therapies or participation in another clinical trial within 30 days prior to first study drug administration | 1 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated Bone marrow plasmacytosis with > or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or > 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis Age > or = 18 years Life expectancy of greater than 12 months Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%) Adequate organ and marrow function as defined below Hgb > or = 9 g/dL Absolute Neutrophil Count > or = 1,500/ ml Platelets > or = 50,000/mm3 Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline Receiving any other investigational agents or therapy within 28 days of baseline Brain metastases Subjects who are pregnant or breast feeding History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3) If a subject is on full-dose anticoagulants, the following should be met for enrollment Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices) Must not have thrombocytopenia requiring transfusion Must have a platelet count > 50,000 Must have stable INR between 2-3 | 0 |
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. | eligible ages (years): 18.0-999.0, Hematological Malignancy Bone Marrow Failure Syndrome Patient ≥ 18 year old. 2. Patients receiving unmanipulated single or double umbilical cord blood allogeneic grafts. 3. Malignant and non malignant indications for transplantation. 4. Myeloablative and reduced intensity conditioning regimens. 5. Patients must meet all other pre-transplantation of the transplantation center including acceptable tests of heart, liver, kidney, and lung function (standard screening for transplantation per PI, and co-investigators). 6. Able to give written informed consent for a clinical trial. 7. Able to comply with study protocol Indications for transplantation 1. Patients with primary myelofibrosis. 2. M7 (French-American-British classification) acute myeloid leukemia. Acute leukemia secondary to a myeloproliferative neoplasm. 3. Patients with persistent acute leukemia (>5% bone marrow blasts) at the time of transplantation. 2. Patients with prior thromboembolic event. Patients with previous catheter related thrombosis will be eligible if more than 3 months elapsed. 3. Hypersensitivity to eltrombopag. 4. Liver enzymes abnormalities: Alanine transaminase (ALT) levels > 3 times the upper limit of normal (ULN) or serum bilirubin > 1.5 ULN (unless due to Gilbert's syndrome or hemolytic bilirubin). 5. Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. A woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization | 0 |
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. | eligible ages (years): 18.0-70.0, Amyloidosis Subject has been medically diagnosed with systemic amyloidosis and falls into one of the patient groups (small to moderate amyloid load involving the spleen for Part A; moderate to large amyloid load involving the spleen (to a moderate/large extent) for Part A (following agreement from external safety committee); moderate to large amyloid load involving the spleen and liver (spleen involved to a moderate/large extent) for Part A extension (if required); and moderate to large amyloid load involving the spleen (and liver in subset of subjects only) for Part B) Alanine aminotransferase (ALT) <3x upper limit of normal (ULN) and bilirubin <1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Male or female between 18 and 70 years of age inclusive, at the time of signing the informed consent Subject is ambulant and capable of attending for the study visit schedule Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form A female subject is eligible to participate if she is of non-childbearing potential; or females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the approved contraception methods Male subjects with female partners of child-bearing potential must agree to use one of the approved contraception methods Smokers (<10 /day) are permitted but must be willing to abstain for the duration of residential study sessions A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening The subject has participated in a clinical trial and has received an investigational therapeutic product (unlicensed) within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). This timeframe will not apply to short term administration of GSK2315698 in study CPH114527 Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing Lactating females Estimated glomerular filtration rate (GFR)<30 milliliter (mL)/minute (min) [<60 mL/min for the first 4 subjects to be enrolled] Evidence of an active urinary sediment on microscopy as evidenced by the presence of red cell casts Decompensated cardiac failure or a recent history of syncope associated with cardiac disease In a subject in whom there is a clinical suspicion of cardiac amyloid, an echocardiogram is consistent with significant cardiac amyloid, whether symptomatic or not Clinically significant anaemia hemoglobin (Hb) <9 gram (g)/deciliter (dL) | 0 |
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. | eligible ages (years): 18.0-65.0, Kidney Failure, Chronic Neuromuscular Blockade age between 18 and 65 years old end-stage renal disease defined by clearance of creatinine < 30 ml/min normal renal function defined by clearance if creatinine > 90 ml/min candidates to elective surgical procedures (control group) or kidney transplantation (renal group) under general anaesthesia pregnant and breastfeeding women patients with known or suspected neuromuscular disorders patients with hepatic disfunction a history of malignant hyperthermia allergy to narcotics, rocuronium or other medication used during general anaesthesia patients receiving medication known to interfere with the action of rocuronium (amino glycoside antibiotics, anticonvulsants, or magnesium) | 0 |
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. | eligible ages (years): 21.0-90.0, AL Amyloidosis Patients with a confirmed diagnosis of AL amyloidosis New York Heart Association class IV On renal dialysis Serum antibodies to mouse protein | 0 |
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. | eligible ages (years): 20.0-65.0, Chronic Renal Disease Male or female patients with end-stage renal disease aged 20 to 65 years undergoing primary kidney transplantation 2. Kidney recipients who should be transplanted a kidney from a decease or living donor aged between 15 and 65 years 3. Patients who have given written informed consent to participate in the study multi-organ recipients, or dual kidney recipients or previous transplant recipients with any organs including the kidney ,bone marrow, or stem cells. 2. Recipients who should be transplanted the kidney from a non-heart beating donor, an ABO incompatible donor ,or a lymphocyte cross-match positive donor 3. Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin. 4. Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or Mycophenolate Mofetil or to any of the excipients. 5. Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferas) such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome. 6. Patients who have tested positive for HIV, HCV and HBV surface antigen. 7. Recipients of organs from donors who tested positive for HBsAg, HCV, HIV 8. Patients with any known hypersensitivity to cyclosporine or other components of the formulations 9. Patients who are applicable to the contradiction of Sandimune Neoral 10. Patients who have received any investigational drug within 30 days prior to study entry. 11. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. 12. Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus. 13. Evidence of drug, alcohol abuse, and/or other psychiatric illness within the last 6 months prior to study enroll 14. At the time of the screen evaluation for this study, patients with platelet count<50,000/mm3, absolute neutrophil count of <1,500/mm3, white blood cell count of < 4,500/mm3, or patients who have an abnormal liver profile such as ALT, AST Alk Phos or total bilirubin>3 times the upper normal limit | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma New Diagnosed or Relapsed Multiple Myeloma Routine Bone Marrow Aspiration will be done Bone Marrow Aspiration is not Needed | 0 |
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. | eligible ages (years): 0.0-17.0, Vitamin D Deficiency Thoracic Surgery Pediatric Disorders Heart Defects, Congenital Newborn (corrected gestational age between 36 weeks) up to 18 years Has CHD that will require surgery within the next 12 months CHD requiring surgical intervention with cardiopulmonary bypass Born at less than 32 weeks gestational age Corrected gestational age of less than 36 weeks Cardiac or gastrointestinal disease preventing enteral feeds or drug administration prior to surgery Patient has confirmed or suspected Williams syndrome Proposed surgery to take place at another centre (outside of CHEO) | 0 |
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. | eligible ages (years): 18.0-999.0, DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma Refractory Plasma Cell Myeloma Serum creatinine =< 2 mg/dL Absolute neutrophil count >= 1000/uL Platelet count >= 50,000/uL Hemoglobin >= 8.0 g/dL Diagnosis of symptomatic MM Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following Serum monoclonal protein >= 1.0 g/dL >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis Serum immunoglobulin free light chain >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio Bone marrow plasma cells >= 30% Prior autologous or allogeneic bone marrow/peripheral blood stem cell transplant More than two prior regimens for therapy of MM Myocardial infarction within 6 months prior to 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; NOTE: Prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant Seroreactivity for human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV) I or II, hepatitis B virus (HBV), hepatitis C virus (HCV) Other active malignancy < 2 years prior to registration; Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer Any of the following Pregnant women or women of reproductive capability who are unwilling to use effective contraception Nursing women Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease | 0 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with confirmed multiple myeloma Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome Active central nervous system (CNS) malignancy Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician Active or uncontrolled infection Diffusing lung capacity oxygenation (DLCO) <50 % | 1 |
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. | eligible ages (years): 18.0-80.0, Multiple Myeloma Age 18 years old Patients with active myeloma requiring systemic treatment Newly diagnosed patients. Relapsed myeloma patients that have not previously had a transplant Meeting for high-risk disease Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable Eastern Cooperative Oncology Group (ECOG) performance status of 0 (see Appendix C) Meet all institutional requirements for autologous stem cell transplantation The patient must be able to comprehend and have signed the informed consent Diagnosis of any of the following cancers POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes) Non-secretory myeloma (no measurable protein on Serum Free Lite Assay) Plasma cell leukemia Diagnosis of amyloidosis Failed to achieve at least a partial response (PR) to latest therapy Previous hematopoietic stem cell transplantation;Patients can have had prior relapsed disease as long as they have never been previously transplanted Known history of HIV infection Use of corticosteroids (glucocorticoids) within 21 days of bone marrow collection Use of any myeloma-specific therapy within 21 days of bone marrow collection | 2 |
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. | eligible ages (years): 18.0-999.0, Multiple Myeloma Key Newly diagnosed, symptomatic multiple myeloma patients for whom treatment is indicated per the National Comprehensive Cancer Network (NCCN) guidelines, and for whom a hematopoietic stem cell transplant is not planned or scheduled during the study or are considered ineligible for hematopoietic stem cell transplant, with measurable disease Creatinine clearance of ≥ 50 mL/min (measured or calculated using the Cockcroft and Gault formula) Key Any prior systemic antimyeloma therapy except oral steroids (dexamethasone up to a total dose of 160 mg or equivalent within 14 days prior to the first dose of study treatment). Use of topical or inhaled steroids is acceptable Radiation therapy within 2 weeks prior to first dose Major surgery within 3 weeks prior to first dose Active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose Clinical significant gastrointestinal bleeding in the 6 months prior to Cycle 1 Day 1 (C1D1) first dose Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of first dose Other malignancy within the past 3 years except those considered cured by surgical resection including some cases of: with the exception of adequately treated basal or squamous cell carcinoma of the skin, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the breast or cervix, carcinoma in situ of the breast, prostate cancer with Gleason Score 6 or less with stable prostate specific antigen levels, or cancer considered cured by surgical resection | 1 |
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. | eligible ages (years): 30.0-70.0, End Stage Renal Disease Pre-transplant ESRD patients between the ages of 30 and 70 years who are listed for renal transplantation Able to sign pre-transplant consent on their own will Have english as their native language Current use of antipsychotics or anti-epileptics Inability to read or write which will limit their ability to perform the cognitive tests Claustrophobia or inability to get MRI for other reasons Unable to sign consent | 0 |
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. | eligible ages (years): 18.0-999.0, Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma STEP 1 Patients must have a confirmed diagnosis of symptomatic multiple myeloma and must be currently relapsed or refractory; all tests for establishing disease status must be completed within 28 days prior to registration and documented on the Baseline Tumor Assessment Form for Multiple Myeloma Patients must have measurable disease within 28 days prior to registration Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden Any maintenance therapy used after an Induction should be considered part of that Induction regimen Use of any agent or combination of agents more than once during the patient's disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens) In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen Patients may not have received any prior carfilzomib treatment Patients must not be receiving any other concurrent therapy considered to be investigational; patients must not be planning to receive any radiotherapy (except localized radiation for palliative care); patients must not be planning to receive any concurrent chemotherapy, immunotherapy, radiotherapy or other treatment with curative intent | 2 |
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