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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Relapsed Multiple Myeloma End-stage Renal Disease Key 1. Relapsed multiple myeloma 2. Evaluable disease (serum protein electrophoresis [SPEP]/urine protein electrophoresis [UPEP]/serum free light chain [SFLC] criteria) 3. Received at least 1 prior treatment regimen or line of therapy for multiple myeloma 4. End-stage renal disease (ESRD) on hemodialysis or CrCl ≥ 75 mL/min 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 6. Adequate organ and bone marrow function 7. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment Key Immunoglobulin M (IgM) multiple myeloma 2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 3. Waldenström Macroglobulinemia 4. Active congestive heart failure (NYHA Class III-IV) ischemia, conduction abnormalities 5. Known human immunodeficiency virus (HIV), recent hepatitis B virus (HBV), hepatitis C virus (HCV) 6. Myelodysplastic Syndrome 7. Contraindication to test article, constituents, or required concomitant medications 8. Other investigational drugs
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient 1 ≤ age < 66 years 2 Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2 3 Patients must be eligible for Autologous Stem Cell Transplantation 4 Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day 5 Female patients of child-bearing potential (FCBP) Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. 6 Male Patients Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy Asymptomatic Multiple myeloma 2 Non-secretory Multiple myeloma 3 Proven AL-amyloidosis 4 Age ≥ 66 years old 5 Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg) 6 Radiation therapy in the 2 weeks preceding randomization 7 National Cancer Institute grade ≥ 2 peripheral neuropathy 8 Haemoglobin < 8g/dL 9 Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL 10 Creatinine level > 170 µmol/L or requiring dialysis. 11
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Documented multiple myeloma according to protocol-defined Evidence of disease progression on the most recent prior treatment regimen based on International Myeloma Working Group Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 Laboratory values and electrocardiogram within protocol-defined parameters at screening Received daratumumab or other anti-CD38 therapies previously Nonsecretory multiple myeloma Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks Exhibiting clinical signs of meningeal involvement of multiple myeloma Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years Seropositive for human immunodeficiency virus, hepatitis B or antibodies to hepatitis B surface and core antigens, or hepatitis C Has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Advanced Multiple Myeloma Key Confirmed multiple myeloma with measurable disease Disease refractory to last myeloma regimen Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment Additional exist. Key Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor Past or current plasma cell leukemia Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed) POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis Known pulmonary hypertension of any severity Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Confirmed diagnosis of symptomatic multiple myeloma and measurable secretory disease For carfilzomib-lenalidomide-dexamethasone (KRd) regimen: newly diagnosed myeloma. For carfilzomib-dexamethasone (CFZ-dex) regimen: relapsed or refractory disease Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 Pretreatment clinical laboratory values must meet protocol-defined parameters during the screening phase Previously received daratumumab or other anti-CD38 therapies Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Peripheral neuropathy or neuropathic pain Grade 2 or higher Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start Exhibiting clinical signs of meningeal involvement of multiple myeloma Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 2 years Seropositive for human immunodeficiency virus, hepatitis B, or hepatitis C Any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study Clinically significant cardiac disease Plasma cell leukemia or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Key 1. Multiple myeloma that is primary refractory or relapsed and refractory after at least 2 lines of standard for multiple myeloma including: 1. ≥ 2 consecutive cycles of both bortezomib and lenalidomide or thalidomide (alone or in combination) 2. In the dose-expansion and Phase 3 portions of the study only: In addition to the above, treatment with adequate alkylator therapy, defined as: i. High-dose melphalan or other alkylating agent as conditioning for autologous or allogeneic stem cell transplant (SCT), or ii. ≥ 6 cycles of induction therapy, or iii. Progressive disease after ≥ 2 cycles 2. Disease progression on or within 60 days of completion of the last therapy 3. Measurable disease as indicated by 1 or more of the following: 1. Serum M-protein ≥ 500 mg/dL 2. Urine M-protein ≥ 200 mg/24 h 3. For patients without measurable serum or urine M protein, serum free light chain (SFLC): Involved free light chain (FLC) concentration ≥ 10 mg/dL provided SFLC ratio is abnormal 4. Males and females ≥ 18 years old 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 Key Systemic chemotherapy with approved or investigational anticancer therapeutics, intended to treat underlying malignancy, within 3 weeks before the first dose or 6 weeks for antibody therapy 2. Dexamethasone at cumulative doses greater than 160 mg or equivalent within 21 days prior to the first dose of study treatment is not allowed. Use of topical or inhaled steroids is acceptable. 3. Radiation therapy within 3 weeks before first dose. Radioimmunotherapy within 8 weeks before first dose. 4. Plasmapheresis is not permitted at any time during the Screening period or while the subject is receiving study treatment. If a subject has started Screening procedures requiring plasmapheresis, or is anticipated to require plasmapheresis during or after the Screen 5. Autologous SCT within 8 weeks or allogeneic SCT within 16 weeks prior to initiation of study treatment. Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-versus-host disease (as defined in Filipovich 2005). 6. Known hypersensitivity to any immunomodulatory drugs (IMiDs), including Grade 4 rash 7. Prior treatment of any duration with pomalidomide 8. Known hypersensitivity or intolerance to dexamethasone 9. Prior exposure to oprozomib 10. Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma in Relapse Histologically confirmed diagnosis of symptomatic multiple myeloma; relapsed disease is myeloma that has previously responded to prior therapy (MR or better) and subsequently progressed Patient must have measurable disease or non-measurable disease, defined as one or more of the following holding true Measurable disease Serum M-protein >= 1.0 g/dL (>= 0.5 g/dL for IgA or IgM myeloma) and/or Urine M-protein >= 200 mg/24 hours and/or Involved serum free light chain level >= 10 mg/dL AND an abnormal serum free light chain ratio For non-measurable disease Baseline marrow burden of myeloma of at least 30% Progression on lenalidomide as part of first line therapy (lenalidomide-refractory disease) * Lenalidomide-refractory disease is defined as disease progression on or progression within 60 days of the last dose of a lenalidomide-based treatment; patients should have received at least 2 cycles of a lenalidomide-based regimen to be evaluable for refractoriness; examples: 1) progression on lenalidomide maintenance therapy after initial induction +/ consolidation; 2) initial response followed by progression on continuous lenalidomide-dexamethasone +/
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Overhydration End Stage Renal Disease Renal Transplantation moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (AHI) ≥ 15/h age ≥ 18 years patient with end stage renal disease on waiting list for a renal transplantation (cadaveric or live donor) unstable congestive heart failure active psychiatric disease amputation of the lower limbs, proximal to the ankle
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Refractory Multiple Myeloma Multiple myeloma (MM) in first relapse or refractory to first line therapy; the previous line of therapy should either an immunomodulatory agent or a proteasome inhibitor Refractory disease is defined as =< 25% response or progression during therapy or within 60 days after completion The number of prior lines of anti-myeloma therapy will be determined as follows Induction chemotherapy for peripheral-blood stem cell harvest followed by planned mobilization and subsequent high-dose chemotherapy with autologous stem cell transplant (ASCT) is considered one therapy regardless of the induction regimen Planned maintenance therapy after stem cell transplantation or other induction therapy is not considered a separate line of therapy, as long as there is no evidence of progression in the time between the induction or transplantation and the initiation of maintenance therapy Two ASCTs within 6 months of each other is considered as one line unless different agents were used in the high-dose therapy-conditioning regimens If the same regimen is repeated after a 6-month interval, they are considered to be two separate therapeutic lines If cyclophosphamide is used for reasons other than planned stem cell mobilization, its use is considered to be a separate line of therapy Dose modification of steroid and altering choices of steroid (i.e. from dexamethasone to prednisone) due to side effects, is not considered a line of therapy, as long as there is no evidence of progression If a regimen was stopped for more than 2 months, its re-initiation is counted as another line of therapy No primary amyloidosis No plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential) No treatment with an investigational product or device within 21 days of cycle 1 day 1 No history of allergic reaction/hypersensitivity to any of the study medications, their analogues or excipients in the various formulations No treatment with cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1 No treatment with a steroid intended to treat myeloma within 14 days prior to cycle 1 day 1 No autologous or allogeneic stem cell transplant within 3 months prior to cycle 1 day 1 No 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 No major surgery within 14 days and minor surgery within 7 days prior to cycle 1 day 1 No pregnant or lactating females
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-85.0, End-stage Renal Disease Hypertension end stage renal disease hypertension (BP≥140/90mmHg) Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Post Allografting Adult patients with multiple myeloma undergoing allogeneic stem cell transplantation in the period 2000-2011 at the University Transplant Center of the Division of Hematology. Were taken into account both donor transplants voluntary blood relative Patients who died early after allogeneic transplantation (<3 months) in which has not been evaluated disease status. In the evaluation of the response of immunophenotypic disease were excluded from the analysis of bone marrow aspirate samples with low cellularity
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Subjects must satisfy the following to be enrolled in the study. 1. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours). 5. Subjects must have had at least 1 prior antimyeloma regimen including lenalidomide and documented progression as per the International Myeloma Working Group uniform response (Durie, 2006) during or after the last antimyeloma regimen. Induction therapy followed by Autologous Stem Cell Transplant and consolidation/ maintenance will be considered as one regimen. 6. Subjects must have an impaired renal function with an estimated Glomerular Filtrate Rate of < 45 mL/min/1.73 m2 according to the modification of diet in renal disease equation. 1. Impaired renal function must be due to multiple myeloma which needs to be confirmed by kidney biopsy. 2. Subjects may have acute myeloma related renal failure or chronic myeloma related renal failure; they may also have been treated with dialysis before, including dialysis with high cut off membranes The presence of any of the following will a subject from enrollment 1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3. Renal insufficiency due to other reasons than multiple myeloma or due to hypocalcaemia only. 4. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years; exceptions the following: 1. Basal or squamous cell carcinoma of the skin 2. Carcinoma in situ of the cervix or breast 3. Incidental histological finding of prostate cancer (Tumour lymphNode Metastasis stage of T1a or T1b) 6. Previous therapy with pomalidomide. 7. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (this includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy). 10. Subjects who are planning for or who are eligible for stem cell transplant
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Amyloidosis Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis Availability to planned measurements and to written informed consent Age < 18 years Indication to organ transplantation Indication to autologous stem cell transplantation Need to start or ongoing dialysis Ascites or massive edema Need to start or ongoing artificial nutrition
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Relapsed and or refractory multiple myeloma after at least one prior line of therapy; there is no upper limit of prior lines of therapy; patients who are ineligible for stem cell transplantation are allowed; patients should have received at least one prior novel agent (immunomodulatory agents or proteasome inhibitors); patients eligible for bone marrow transplant must have undergone bone marrow transplant (BMT) prior to enrollment Measurable disease, as defined by one or all of the following (assessed within 30 days prior to initiation of therapy): a) serum M-protein >= 0.5 g/d; b) urine Bence-Jones protein >= 200 mg/24 hours; c) patients with light chain only myeloma are eligible; the involved free light chain level 100 mg/L with abnormal serum free light chain ratio Documented relapse or progressive disease on or after any regimen (subjects refractory to the most recent regimen are eligible) Primary refractory patients (never responded to any therapy) are eligible Eastern Cooperative Oncology Group performance status 0 Serum alanine aminotransferase (ALT) < 3.5 times the upper limit of normal within 30 days prior to cycle 1 day 1 Serum direct bilirubin < 2 mg/dL (34 Omol/L) within 30 days prior to cycle 1 day 1 Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 30 days prior to cycle 1 day 1, without granulocyte-colony stimulating factor (G-CSF) Hemoglobin > 9 g/dL (80 g/L) within 30 days prior to cycle 1 day 1 (subjects may be receiving red blood cell transfusions in accordance with institutional guidelines) Platelet count > 100 x 10^9/L (30 x 10^9/L if myeloma involvement in the bone marrow aspirate is > 50%) within 30 days prior to cycle 1 day 1; subjects may receive platelet transfusions within institutional guidelines Intolerance to previous bendamustine, carfilzomib or dexamethasone or mannitol; subjects who are allergic to bortezomib are not excluded Chemotherapy (approved or investigational) within 3 weeks prior to the first day of treatment or antibody therapy within 6 weeks prior to the first day of treatment Radiotherapy to >= 3 sites at the same time within 1 week prior to the first day of treatment Immunomodulatory therapy such as immunomodulatory drugs (Imids) or stem cell transplant within 28 days prior to the first day of treatment Pregnant or lactating females Major surgery within 21 days prior to the first day of treatment Acute active infection requiring treatment (IV antibiotics, antivirals, or antifungals) within 14 days prior to the first day of treatment Known human immunodeficiency virus infection Known active hepatitis B or C infection Unstable angina or myocardial infarction within 4 months prior to the first day of treatment, the New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Lymphoma, Non-Hodgkin At least 18 years of age Diagnosis of multiple myeloma or non-Hodgkin lymphoma Eligible for autologous transplantation Adequate bone marrow function as defined as White Blood Cell Count ≥ 3.0x109/L Absolute Neutrophil Count ≥ 1.5x109/L Platelet Count ≥ 100x109/L Able to understand and willing to sign an IRB-approved informed consent document Surgically or biologically sterile or willing to practice acceptable birth control, as follows Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day 1 of study treatment. Women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Acceptable methods of birth control barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence Previous autologous stem cell collection Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products Pregnant or breastfeeding
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma in Relapse Refractory Multiple Myeloma Multiple Myeloma Subjects must meet the following to be eligible for study participation: 1. At least 18 years at the time of signing the informed consent form. 2. Able to understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Documented diagnosis of multiple myeloma and measurable disease by serum or urine protein electrophoresis (SPEP or UPEP): SPEP ≥0.5 g/dL, UPEP ≥200 mg/24 hours, or involved serum free light chain (FLC) level ≥10 mg/dL provided the serum FLC ratio is abnormal. 5. Previously received 1 or more lines of anti-myeloma therapy that must have included both lenalidomide and bortezomib (either separately or in combination). 6. Documented disease progression during or within 60 days after their most recent line of anti myeloma therapy. 7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. 8. All study participants in the USA must be registered into the mandatory REMS™ (Risk Evaluation & Mitigation Strategy) program, and be willing and able to comply with the requirements of the REMS™ program. 9. All study participants in the USA who are females of child-bearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the REMS™ program. 10. All study participants outside the USA must agree to comply with the PPRMP requirements. 11. All subjects must be able and agree to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). 12. For females of child bearing potential (FCBP): Agree to use 2 reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study treatment, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation; must follow pregnancy testing requirements as outlined in the REMS™ program or the PPRMP. 13. For all females: Agree to abstain from breastfeeding during study participation and for at least 28 days after study treatment discontinuation. 14. For all males: Agree to use a latex or synthetic condom during any sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from study treatment, even if he has undergone a successful vasectomy. 15. For all males: Agree to refrain from donating semen or sperm while on study and for at least 28 days after discontinuation from study treatment. 16. Refrain from donating blood while on study treatment and for at least 28 days after discontinuation from study treatment. 17. Agree not to share medication Subjects with any of the following will be excluded from participation in the study: 1. Peripheral neuropathy Grade ≥2. 2. Non-secretory multiple myeloma. 3. Any of the following laboratory abnormalities ANC <1,000/µL Platelet count <50,000/µL for subjects in whom <50% of bone marrow nucleated cells are plasma cells; or a platelet count <30,000/µL for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells Creatinine clearance (CrCL) <45 mL/min as measured directly or as calculated according to Cockcroft Gault formula Corrected serum calcium >13.5 mg/dL (>3.4 mmol/L) Hemoglobin <8 g/dL (<4.9 mmol/L; prior red blood cell [RBC] transfusion or recombinant human erythropoietin use is permitted before study entry) Serum aspartate aminotransferase (AST) >3.0 x upper limit of normal (ULN) Serum alanine aminotransferase (ALT) >3.0 x ULN Serum total bilirubin >1.5 x ULN (>3.0 x ULN for subjects with known Gilbert's disease). 4. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥5 years. Subjects may be entered earlier than 5 years if they have received curative treatment for the following Basal cell carcinoma of the skin
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Amyloidosis Diagnosis of systemic immunoglobulin light-chain (AL) amyloidosis Written informed consent Age <18 years Ongoing artificial nutrition Unavailability to planned measurements
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Symptomatic multiple myeloma requiring treatment Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy At least 18 years of age Adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved, peripheral blood stem cell collection containing at least 2 × 10^6 CD34+ cells/kg based on patient body weight Adequate organ function as measured by Cardiac function: Left ventricular ejection fraction at rest ≥40% Hepatic function: Bilirubin ≤2 × ULN and aspartate amino transferase/alanine amino transferase (AST/ALT) ≤3 × ULN Renal function: Creatinine clearance ≥40 mL/minute (measured or calculated/estimated) Pulmonary function: Carbon monoxide diffusing capacity (DLCO; corrected for hemoglobin [Hgb]), forced expiratory volume in 1 second (FEV1), forced expiratory vital capacity (FVC) ≥50% of predicted value Oxygen saturation ≥92% on room air Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior to ASCT Prior stem cell transplant (autologous or allogeneic) Smoldering MM not requiring therapy Plasma cell leukemia Systemic amyloid light chain amyloidosis Active bacterial, viral, or fungal infection Seropositive for human immunodeficiency virus (HIV) Known, active hepatitis A, B, or C Infection Pregnant or breastfeeding Receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the ASCT or planning to receive any of these treatments prior to the last study visit on Day +100
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Subjects must meet all of the following to be eligible for enrollment into the study: Related to initial diagnosis and prior Melphalan Prednisone Velcade (MPV) induction therapy 1. Previously untreated and symptomatic multiple myeloma. 2. All 3 (Durie, 2003) and at least one of the Creatinine Renal insufficiency Anemia lytic Bone lesions or osteoporosis must be met. 3. Measurable disease by protein electrophoresis analyses. 4. All subjects must be treated with a minimum of 6 and a maximum of 9 cycles of MPV induction regimen, and must have achieved at least Partial Response as best overall response and maintained at Melphalan Prednisone Velcade discontinuation. If a subject achieves Complete Response prior to at least 6 cycles, the subject will be eligible, but a minimum of 6 cycles must be administered otherwise. 5. Subjects must not have received any prior anti-myeloma chemotherapy or any investigational agent except 6-9 cycles of induction therapy with Melphalan Prednisone Velcade. 6. Subjects must have cytogenetic (17 p deletion, and 4;14 translocation), β-2 microglobulin and serum albumin (International Staging System) results from their initial diagnosis available at the time of screening. Related to the subject 7. Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures, 8. Age ≥ 65 years: if < 65 years of age, the subject must be non eligible for stem cell transplantation, 9. Eastern Cooperative Oncology Group performance status score ≤ 2, 10. Able to adhere to the study visit schedules and other protocol requirements, 11. Females of Childbearing Potential must: 1. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence2 from heterosexual contact. 2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting Investigational Product, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. 12. Male Subjects must: 1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female or childbearing potential while participating in the study, during dose interruptions and for at least 28 days following Investigational Product discontinuation, even if he has undergone a successful vasectomy. 2. Agree to not donate semen during Investigational Product therapy and for 28 days after end of study therapy. 13. All subjects must: 1. Have an understanding that the study medication could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking Investigational Product therapy and following discontinuation of Investigational Product therapy. 3. Agree not to share study medication with another person. 4. All female of childbearing potential and male subjects must be counseled about pregnancy precautions and risks of fetal exposure The presence of any of the following will the subject from the study enrollment: 1. Previous treatment with anti-myeloma therapy other than the required 6-9 cycles of Melphalan Prednisone Velcade induction therapy (does not local radiotherapy, bisphosphonates, or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]). 2. Subjects who didn't achieve Partial Response or better after getting at least 6 cycles of Melphalan Prednisone Velcade and at the end of Melphalan Prednisone Velcade whatever the overall response are not eligible. 3. Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or desoxyribonucleic acid modulating agents. Subjects who received investigational agents are also excluded. 4. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 5. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 6. Pregnant or lactating females. 7. Any of the following laboratory abnormalities: Absolute neutrophil count < 1,000/L (1.0 x 10*9/L) Untransfused platelet count < 50,000 cells/L (50 x 10*9/L) Serum glutamic oxaloacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase > 3.0 x upper limit of normal Serum bilirubin levels > 1.5 x upper limit of normal 8. Renal insufficiency (creatinine clearance < 30 mL/min by Cockcroft-Gault method) or actual creatinine clearance result, or renal failure requiring hemodialysis or peritoneal dialysis. 9. Prior history of malignancies including skin cancer, other than multiple myeloma. 10. Prior history of deep venous thrombosis or pulmonary embolus within 3 years of randomization. 11. Subjects who are unable or unwilling to undergo anti-thrombotic therapy. 12. Peripheral neuropathy of > Grade 2 severity according to the National Cancer Institute Common Terminology for Adverse Events Version 4.0. 13. Known Human Immunodeficiency Virus positivity or active infectious hepatitis, type A, B, or C. 14. Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis. 15. Prior allogeneic or autologous stem cell transplantation. 16. Significant active cardiac disease within the previous 6 months including: New York Heart Association class II-IV congestive heart failure Unstable angina or angina requiring surgical or medical intervention Myocardial infarction 17. Any condition that confounds the ability to interpret data from the study
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Hodgkin Lymphoma Non-Hodgkin Lymphoma Each patient must meet all of the following Patient must have a histologically proven diagnosis of any EBV+ Hodgkin or non-Hodgkin lymphoma EBV positive will be defined as positive if LMP1 or 2 or EBER are positive. As long as EBV positive on a prior biopsy, EBV testing will not be required at the time of relapse. However, if EBV testing performed on a more recent biopsy and it is negative, that patient will be excluded Patients must have had persistent, relapsed, or refractory disease to at least one prior regimen with plans to proceed to autologous stem cell transplant Patients must be in a complete remission at time of initial pheresis for vaccine preparation; complete remission will be determined using Cheson Criteria100 There are no limits on the number of prior therapies allowed Able to give voluntary written informed consent 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 therapy and for 3 months after vaccine #2 Male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 3 months after vaccine #2 Patients must be 18 years of age or older An estimated or measured creatinine clearance of less than 30 ml/min AST, ALT, total bilirubin > 3 times the upper limit of normal Patients on chronic immunosuppressive therapy for any reason (other than chemotherapy for HL) Chronic systemic steroid therapy at doses greater than 10mg/day of prednisone or its equivalent Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result within 48 hours of enrollment. Pregnancy testing is not required for post-menopausal or surgically sterilized women Patient has received other investigational drugs for this disease within 14 days of enrollment Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patients who are HIV positive AND have a CD4 count <50 Prior solid organ transplant or allogeneic stem cell transplant
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Clostridium Difficile Inpatient or outpatient adults, age ≥18 Have had at least 1 relapse of C. difficile Patients who have had previous FMT Pregnant or breastfeeding Critically or acutely ill (Fever will be defined as a documented temperature >37.8°C) Ileus or toxic megacolon Unable to give consent
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 21.0-999.0, Amyloid Neuropathy, Carpal Tunnel Adult patients older than 21 years with carpal tunnel syndrome with surgical indication (moderate to severe symptoms that do not respond to conservative treatment physiotherapy, splinting, activity modification) for more than 6 months Refusal to participate or to the process of informed consent Secondary acute carpal tunnel syndrome (eg ganglion) Formal contraindication surgical treatment
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma Amyloidosis Participant Participants with end-stage renal failure due to or in association with multiple myeloma or systemic AL amyloidosis which hematopoietic cell transplantation is appropriate and a ≥ 50% five-year survival probability with transplantation is expected. This includes, but is not limited to Multiple myeloma (MM), ISS stage II or III in complete or very good partial remission AL amyloidosis without significant cardiac disease Males or females 18 years of age Participants must have an HLA-matched or one of six HLA A, B, or DR antigen-mismatched related donor, with high resolution molecular class I and II allele typing Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 2 years following the transplant Participants should be on dialysis or have a CrCl <20 ml/min Patients should not have evidence of renal recovery of their renal failure over a 90 day period of therapy for their underlying malignancy or other blood disorder Evidence of active infection as defined by: a) clinical syndrome consistent with viral or bacterial infection (e.g., influenza, URI, UTI) or b) fever with a clinical site of infection identified, or c) microbiologically documented infection, including, but not limited to, bacteremia or septicemia Participation in other investigational drug use at the time of enrollment Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to horse serum in ATG) Serologic positivity to HIV or HCV Women of childbearing age in whom adequate contraception cannot be maintained AST/ALT > 3 x normal or bilirubin > 1.5 x normal (unless due to Gilbert's syndrome) Pregnancy or uncontrolled serious medical illness not related to underlying myeloma Cardiac ejection fraction < 40% by echocardiogram FEV1 < 50% predicted or corrected DLCO < 50% predicted ABO blood group incompatibility in the host-vs-graft direction
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, End Stage Renal Disease The patient is not a candidate for a native fistula The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease The patient has been on hemodialysis for ≥1 month The patient is scheduled for a different surgical procedure within 30 days post Index Procedure The patient has a known hypercoagulable disorder or bleeding disorder The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma KEY 1. Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard in patients who received allogeneic transplant due to high-risk prognostic features, such as, but not limited to Chromosome 17p, partial deletion [del(17p)], t(4;14), t(14;16), t(14;20) Plasma cell leukemia PFS of less than 2 years after autologous stem cell transplant 2. Evidence of engraftment of neutrophils (absolute neutrophil count [ANC] >1000 cells/mm3) and platelets (platelets >60,000 cells/mm3) [dose escalation phase] and >50,000 cells/mm3 [dose expansion phase]). 3. Achievement of at least a PR prior to allogeneic stem cell transplant 4. Adequate liver and kidney function 5. Ability to swallow oral medication 6. Absence of gastrointestinal symptoms that precludes oral intake and absorption of MLN9708 7. Off antibiotics and amphotericin B formulations, voriconazole or other anti-fungal therapy for the treatment of proven, probable or possible infections 8. ECOG of ≤ 2 9. Life expectancy ≥3 months 10. Ability to understand the nature of this study and give written informed consent Patients with progressive disease when compared to pre-transplant staging as defined by IMWG Uniform Response for Multiple Myeloma. 2. Umbilical cord blood transplant 3. Patients with > Grade 2 peripheral neuropathy with pain, or ≥ Grade 3 peripheral neuropathy per NCI CTCAE Version 4.0 4. Patients with uncontrolled bacterial, viral, or fungal infections 5. 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. 6. Patients who are pregnant or breastfeeding 7. Most recent chemotherapy ≤21 days and ≤ Grade 1 chemotherapy-related side effects, with the exception of alopecia 8. Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of MLN9708. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of MLN9708 is required. 9. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤14 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy 10. Major surgical procedures ≤14 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement. 11. Ongoing or active systemic infection. Known diagnosis of human immunodeficiency virus, hepatitis B, or hepatitis C 12. Central Nervous System involvement 13. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. 14. Systemic treatment with moderate and strong inhibitors of cytochrome P450 (CYP) 1A2, CYP3A, or clinically significant CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before study drug administration in the study. 15. Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer. 16. Graft versus host disease > Grade 2; or GVHD grade 1 or Grade 2 which requires > 0.5 mg/kg methylprednisolone, or equivalent. There are additional Inclusion/ The Study Center will determine if you meet all and will answer any questions you may have about the trial
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Heart Failure Multiple Myeloma Relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care Received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy) Males and females ≥ 18 years of age Able to provide written informed consent in accordance with federal, local, and institutional guidelines POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) Known or suspected AL amyloidosis, secondary amyloidosis or cardiac amyloidosis Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential) Waldenström Macroglobulinemia Myelodysplastic syndrome History of MI within the last 3 months Symptomatic unstable cardiac arrhythmia requiring treatment in the past 3 months Class 3 or 4 New York Heart Association Heart Failure in the past 3 months Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma This study is intended for patients with relapsed and/or refractory multiple myeloma, who have received at least one prior line of therapy. Patients must require retreatment as per IMWG definitions (Kyle et al 2003). Approximately 50-100 patients are expected to be enrolled into this trial Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003 definitions all three of the following had been met Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on serum or on total 24 hour urine (or demonstration of M protein in cytoplasm of plasma cell for non secretory myeloma) 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) Patients who have received allogeneic stem cell transplant and do not have active graft vs host disease requiring immunosuppressive therapy are eligible Patient with multiple myeloma (per IMWG 2003 definition) that is relapsed and/or refractory to at least one prior line of therapy and requires retreatment Relapsed-and-refractory to a therapy, provided that the patient meets any of the following conditions Relapsed, defined by disease that recurred in a patient that responded under a prior therapy, by reaching a MR or better, and had not progressed under this therapy nor up to 60 days of last dose of this therapy. Patients who previously responded to treatment with BTZ are eligible Patient has relapsed to at least one prior line and patient was refractory to at least one prior line by either not reaching a MR, or progressed while under this therapy, or within 60 days of its last dose. Patients previously refractory to BTZ are also eligible Patient has shown intolerance to bortezomib, dexamethasone or panobinostat or has any contraindications to any of these therapies. following available prescribing information Allogeneic stem cell transplant recipient presenting with graft versus host disease either active or requiring immunosuppression Patient has grade ≥ 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination within 14 days of treatment Patient taking any anti-cancer therapy concomitantly Patient has second primary malignancy < 3 years of first dose of study treatment (except for treated basal or squamous cell carcinoma, or in situ cancer of the cervix)
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-999.0, Multiple Myeloma Patient with relapse/refractory multiple myeloma who experienced biochemical progression, without CRAB, during treatment with Rd. CRAB means the presence of organ damage, multiple myeloma related (renal impairment and/or anemia and/or new bone lesions and/or hypercalcemia). It is sufficient one of the previous signs for defining the presence of CRAB. Biochemical progression means: positivization of serum/urine immunofixation for patients who reached a complete remission with Rd treatment or at least 25% increment of monoclonal component in serum/urine for patients who reached at least a stable disease (SD) Patient exposed to previous therapy included Lenalidomide, Thalidomide, Bortezomib and/or autologous stem cell transplantation (ASCT) and in treatment with Rd Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Female patient is either post-menopausal or surgically sterilized or, if at childbearing 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 Patients with newly diagnosed multiple myeloma Patients who relapsed from multiple myeloma with signs of organ damage related to disease (CRAB) 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 histological finding of prostate cancer (TNM stage of T1a or T1b)
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-73.0, Myeloma, Plasma-Cell Myeloma-Multiple 1.1.1 Multiple Myeloma Clear B-cell maturation antigen (BCMA) expression must be detected on greater than 50% of malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry. These assays must be performed at the National Institutes of Health. It is not required that the specimen used for BCMA determination comes from a sample that was obtained after the patient's most recent treatment. BCMA expression will need to be documented on the majority of malignant plasma cells at some time after the original anti-BCMA chimeric antigen receptor (CAR) T-cell infusion in all patients undergoing a second anti-BCMA CAR T-cell infusion. If paraffin embedded unstained samples of bone marrow involved with multiple myeloma (MM) or a plasmacytoma are available, these can be shipped to the National Institutes of Health (NIH) for BCMA staining, otherwise new biopsies will need to be performed for determination of BCMA expression Bone marrow plasma cells must make up 30% or less of total bone marrow cells based on a bone marrow biopsy performed within 30 days of the start of protocol treatment Patients must have received at least 3 different prior treatment regimens for multiple myeloma Patients must have measurable MM as defined by at least one of the below. a. One or more of these abnormalities defines measurable disease Serum M-protein greater or equal to 1 g/dl (10 g/l) Urine M-protein greater or equal to 200 mg/24 h Serum free light chain (FLC) assay: involved FLC level greater or equal to10 mg/dl (100 mg/l) provided serum FLC ratio is abnormal A biopsy-proven plasmacytoma Patients must have multiple myeloma that meets the for one of the following Disease categories: (1) progressive disease or (2) relapse from Complete Remission (CR) as described in the International Uniform Response for Multiple Myeloma and as listed below. 1. Progressive Disease (which requires 1 or more of the following)(A): Increase of greater than or equal to 25% from the lowest response value (nadir) in any one or more of these parameters: 1. Serum M-component (the absolute increase must be greater than or equal to 0.5 g/dL) (B) and/or 2. Urine M-component and/or (the absolute increase must be greater than or equal to 200 mg/24 h) 3. Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL. 4. Bone marrow plasma cell percentage; the absolute percentage must be greater than or equal to 10%
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB as specified in the appendix I) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference 2. Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements (Durie et al., 2006) Serum M-protein ≥ 10g/l Urine light-chain (M-protein) of ≥ 200 mg/24 hours Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal 3. Age>18 years 4. WHO performance status 0-3 (WHO=3 is allowed only when related to MM and not to co-morbid conditions) (see appendix III) 5. For women of childbearing potential: negative pregnancy test at 6. All patients must be willing and capable to use adequate contraception during the complete therapy. 7. All patients must agree to abstain from donating blood while on study 8. Ability to understand character and individual consequences of the clinical trial 9. Written informed consent (must be available before enrolment in the trial) Subjects presenting any of the following will not be included in the trial 1. Patient has known hypersensitivity to bortezomib, bendamustine and prednisone or to any of the constituent compounds (incl. boron and mannitol). 2. Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow) 3. Chemotherapy or radiotherapy during the past 5 years except patients with local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.) 4. Plasma cell leukemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2 plasma cells/nl. 5. Severe cardiac dysfunction (NYHA classification III-IV, see appendix III) 6. Significant hepatic dysfunction (serum bilirubin ≥ 2 mg/dl or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma 7. Patients known to be HIV-positive 8. Patients with active, uncontrolled infections 9. Patients with peripheral neuropathy or neuropathic pain of CTC grade 2 or higher (as defined by the NCI Common Terminology for Adverse Events (NCI CTCAE) Version 4.0, see appendix V) 10. Second malignancy during the past 5 years except Adequately treated basal cell or squamous cell skin cancer, or Carcinoma in situ of the cervix, or Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or Similar malignant condition as a d. with an expected5-year disease free survival larger than 95% 11. Patients with acute diffuse infiltrative pulmonary and pericardial disease 12. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia 13. Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma 14. Hemoglobin < 7.5g/dl, unless related to myeloma 15. Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma 16. Pregnancy and lactation 17. Participation in other clinical trials within one month prior to enrolment except for supportive care studies and vaccination studies. (Note: this does not long-term follow-up periods without active drug treatment of previous studies during the last 6 months). No subject will be allowed to enrol in this trial more than once
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-80.0, Osteoarthritis of the Knee Signed informed consent by the subject Age greater than or equal to 18 years Ability to understand the planned treatment Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification Pregnant or lactating women Women of childbearing potential unwilling to use two forms of contraception Cognitively impaired adults Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging Inflammatory or postinfectious arthritis More than 5 degrees of varus or valgus deformity Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age Intraarticular corticosteroid injection within the previous 3 months A major neurologic deficit Serious medical illness with a life expectancy of less than 1 year
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma First Relapse Patients must have been treated in first line within the IFM/DFCI 2009 trial to be treated within the PCD trial in second line 2. Must be able to understand and voluntarily sign an informed consent form 3. Must be able to adhere to the study visit schedule and other protocol requirements 4. Age: 18-70 years 5. Life expectancy >6 months 6. Patients must have progressive (+/ symptomatic) Myeloma as defined by the IMWG with increase of ≥25% from lowest response value in any one or more of the following Serum M-component and/or (the absolute increase must be ≥0.5 g/dl) Urine M-component and/or (the absolute increase must be ≥200 mg/24h) Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dl Bone marrow plasma cell percentage; the absolute percentage must be ≥10% Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium >11.5 mg/dl or 2.65mmol/l) that can be attributed solely to the plasma cell proliferative disorder. 7. Patients must have a clearly detectable and quantifiable monoclonal M-component value IgG (serum M-component >10g/l) IgA (serum M-component >5g/l) Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation 2. Primary amyloidosis or myeloma complicated by amyloidosis 3. Pregnant or breast feeding females 4. Use of any other experimental drug or therapy within 2 weeks before study treatment initiation (except local radiotherapy and/or corticosteroid until dose of dexamethasone 160mg) 5. Known positive for HIV or Active infectious hepatitis, type B or C 6. Patients with non-secretory MM 7. Prior history of malignancies within 10 years 8. Evidence of Central Nervous System (CNS) involvement 9. Any >grade 2 toxicity unresolved 10. Peripheral neuropathy >grade 2 11. Known hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone 12. Ongoing active infection, especially ongoing pneumonitis 13. Participant with clinical signs of heart or coronary failure, or evidence of Left Ventricular Ejection Fraction (LVEF) inferior to 40%. Participant with myocardial infarction within 6 months prior to enrolment or have New York Heart Association (NYHA) Class III or IV heart failure, and controlled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 14. Inability or unwillingness to comply with birth control requirements 15. Unable to take antithrombotic medicines at study entry 16. Unable to take corticotherapy at study entry 17. Scheduled vaccination with a live agent such as yellow fever vaccine 18. Individually deprived of liberty or placed under the authority of a tutor
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 20.0-999.0, Multiple Myeloma Diagnosis of multiple myeloma based on the standard Measurable, secretory multiple myeloma is defined as serum monoclonal immunoglobulin (Ig) G of >= 10 gram per liters (g/L), serum monoclonal IgA or IgE greater than or equal to (>=) 5 g/L, serum monoclonal IgD >= 0.5 g/L, or serum monoclonal IgM present (regardless of level), or urine M protein of >= 200 mg/24 hour at any time point of prior treatment Relapse or progression of myeloma following prior systemic antineoplastic therapy and meet the indication which had been approved in the drug leaflet. Relapse is defined as: a) reappearance of measurable disease (as defined above) following complete response (CR); b) >= 25 percent (%) increase in serum or urine M-protein according to IMWG (International Myeloma Working group) criteria; c) development of new or worsening lytic bone disease; d) new plasmacytomas or >=50% increase in the longest dimension of an existing plasmacytoma; e) worsening hypercalcemia (corrected serum calcium >11.5 milligram per deciliters [mg/dL-2.8 millimoles per liters [mmol/L] due to multiple myeloma Karnofsky performance status >=70% Platelet count >=50 × 10^9 /L without transfusion support within 7 days before the laboratory test More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval) Peripheral neuropathy or neuropathic pain of National Cancer Institute-Common Terminology for Adverse Events (NCI CTCAE) Version 4.03 Grade >=2 Any of the following within 3 weeks prior to enrollment in the study: antineoplastic or experimental therapy, corticosteroid use above 10 mg/day (prednisone or equivalent), or plasmapheresis Any of the following within 2 weeks prior to enrollment in the study: radiation therapy, major surgery (kyphoplasty is not considered major surgery) Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-85.0, End-Stage Renal Disease Maintenance hemodialysis therapy for end-stage renal disease 2. Age 18-85 years 3. ≥3 calendar months since dialysis initiation. Note if a patient has been on dialysis for ≥3 but less than 6 calendar months, there must be no hospitalizations during the 6 weeks prior to screening, and no change in estimated dry weight (EDW) within 2 weeks of the screening date. 4. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug. 5. Ability to provide informed consent Serum potassium ≥6.5 mEq/L within the 3 months prior to screening 2. Serum potassium level ≥6.0 mEq/L within 2 weeks prior to the baseline visit. If a potassium value is not available through routine clinical care during this 2-week period a potassium measurement will be performed as a research test. 3. Unscheduled dialysis for hyperkalemia within the 3 months prior to screening 4. Pre-dialysis systolic blood pressure <100 mm Hg within 2 weeks prior to screening or at the baseline visit 5. 2 or more dialysis sessions within the month prior to screening with either 2 intra-dialytic measurements of systolic blood pressure <80 mm Hg or muscle cramping, light-headedness, nausea or hypotension requiring infusion of saline or other intervention directed at hypotension 6. Current dual use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) 7. Current use of digoxin 8. Current use of spironolactone or eplerenone 9. Allergy to spironolactone 10. Inability to maintain dialysis machine blood flow ≥300 mL/min during any of the most recent 3 dialysis sessions prior to the screening visit as an indicator of vascular access dysfunction 11. Mitral valve repair or replacement 12. Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging 13. Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months 14. Expected survival <9 months 15. Pregnancy, anticipated pregnancy, or breastfeeding 16. Incarceration 17. Participation in another intervention study
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Relapse/Refractory Multiple Myeloma Patient had a previous diagnosis of multiple myeloma Patient required retreatment for multiple myeloma Patient had measurable M component in serum or urine at study screening Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy) Patient who had 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 Patient received prior treatment with DAC inhibitors including panobinostat Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Arteriovenous Fistula Patients with ESRD undergoing radio-cephalic AVF Previous AVF procedures significant stenosis (>50% diameter reduction) calcifications of radial artery or cephalic vein radial artery diameter <1.6mm cephalic vein diameter <2.0mm history of pre-existing unilateral recurrent laryngeal nerve palsy pre-existing unilateral phrenic nerve palsy coagulopathy or pre-existing conditions that require anticoagulants or anti-platelet therapies history of IV drug use documented allergic reactions to local anesthetics
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma High-Risk Cancer Age 18 to 65 years, inclusively Newly diagnosed multiple myeloma patients (according to IMWG criteria) with measurable disease at diagnosis, based on presence of any of the following: 1. Serum intact immunoglobulin ≥ 10 g/L; 2. Bence-Jones proteinuria ≥ 200 mg/day; 3. Serum free light chain (sFLC) assay ≥ 100 mg/L (difference between involved and uninvolved FLC levels) and an abnormal sFLC ratio High-risk patients presenting any of the following: 1. International Staging System (ISS) III; 2. del(17p13), t(4;14) with ISS II or III, t(14;16), t(14;20) and chromosome 1 abnormalities by FISH. At this time, there is no international consensus on the threshold to consider these cytogenetic abnormalities as significant. For this study, investigators will consider arbitrarily a percentage ≥ 10% as significant. 3. Plasma cell leukemia,defined as an absolute blood plasma cell count > 2 x 109/L and the presence of > 20% plasma cells among peripheral blood white cells; 4. Patients ≤ 50 years, regardless of cytogenetics or ISS stage Having received a Bortezomib-containing regimen (VTD, CyBorD, VRD or PAD [in patients with PCL]) for a minimum of 4 cycles with ≥ PR Received high-dose Melphalan ≥ 140 mg/m2 followed by autologous stem cell transplantation Available HLA-identical sibling donor or 8/8 allele matched (HLA-A, -B, -C, -DR) matched unrelated donor Failure to achieve at least PR with a Bortezomib-based induction therapy Progressive disease at any time Having received tandem autologous stem cell transplantation Having received maintenance or consolidation therapy with Bortezomib after ASCT. If delays to allogeneic transplant are expected, Lenalidomide at 10 mg die for a maximum of three months will be allowed after ASCT (initiated after day +90) and discontinued at least 14 days before the start of the conditioning regimen Karnofsky score < 70% or comorbidity index HCT-CI > 3 Bilirubin > 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis; AST and ALT > 2.5 x ULN; alkaline phosphatase > 5 x ULN Peripheral neuropathy or neuropathic pain ≥ grade II Poor organ function Known hypersensitivity to boron, mannitol or Bortezomib Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B (defined as HBsAg positivity) or hepatitis C (defined as anti-HCV positivity or HCV-RNA positivity)
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Myelodysplastic Syndrome Acute Myeloid Leukemia Participants must meet the following on screening examination to be eligible to participate in the study A diagnosis of recurrent, persistent, or progressive acute myelogenous leukemia (AML), defined as >= 5% blasts in a patient with known prior history of AML, or recurrent, persistent, or progressive myelodysplastic syndrome (MDS) according to WHO criteria Must have undergone an allogeneic SCT (regardless of stem cell source) Patients must be 18 years or older Able to adhere to study schedule and other protocol requirements Must be off all immunosuppressive medications (except prednisone) for at least 2 weeks prior to study entry Must be on less than 21 mg of oral prednisone daily for GVHD ECOG performance status 0-2 (see Appendix 2) Participants must have the following organ function all within 21 days prior to enrollment Total bilirubin ≤ 2.0 mg/dl unless due to underlying conjugation disease such as Gilbert's Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study Ejection fraction < 40% obtained by either MUGA or echocardiogram Patients who had had a myocardial infarction within 6 months of enrollment or have New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, 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 Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the consent form Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Patients with major surgery within 28 days prior to trial enrollment Patients with greater than or equal to grade 2 peripheral neuropathy or active herpes infection Patients with ≥ grade 3 acute graft-versus-host disease are excluded from the study Patients with moderate or severe chronic graft-versus host requiring more than 20 mg of oral prednisone therapy are excluded from the study Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cirrhosis, chronic obstructive or restrictive pulmonary disease, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Primary Systemic (AL) Amyloidosis Key 1. Age ≥ 18 years 2. Newly diagnosed, AL amyloidosis treatment naïve 3. Bone marrow consistent with plasma cell dyscrasia 4. Confirmed diagnosis of AL amyloidosis 5. Cardiac involvement 6. Planned first-line chemotherapy contains a proteasome-inhibiting agent administered weekly 7. Adequate bone marrow reserve, hepatic and renal function Key Non-AL amyloidosis 2. Meets diagnostic for symptomatic multiple myeloma 3. Subject is eligible for and plans to undergo ASCT 4. History of Grade ≥ 3 infusion-associated AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine or acetaminophen
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 20.0-80.0, Osteoarthritis Arthritis Rheumatoid Arthritis Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision of previously failed total hip arthroplasty. 6. age over 20 years old uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2. osteoporosis, 3. metabolic disorders which may impair bone formation, 4. osteomalacia, 5. distant foci of infections which may spread to the implant site, 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7. vascular insufficiency, muscular atrophy, or neuromuscular disease
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation ≥ 18 years of age Patients of African, European, and Hispanic descent History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF ECG that was recorded within 1 month of randomization showing AF Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD Able to give informed consent Permanent AF or isolated atrial flutter Cardiac or thoracic surgery within the previous 6 months Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital) Medical condition that is likely to be fatal in less than one year A history of prior AF ablation Have already been tried on 2 or more AADs in the past for AF Creatinine clearance <40 ml/min Left ventricular ejection fraction < 50% Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc>480 ms in females and >460 ms in males at baseline
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Plasma Cell Myeloma Plasmacytosis Recurrent Plasma Cell Myeloma Smoldering Plasma Cell Myeloma Patients with symptomatic active multiple myeloma requiring treatment, including those whose prior smoldering myeloma progressed to symptomatic disease requiring chemotherapy; both newly diagnosed and previously treated patients are eligible for the study Presence of quantifiable M-component of immunoglobulin G (IgG), IgA, IgD, or IgE and/or urinary kappa or lambda light chain or Bence Jones protein, in order to evaluate response; non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (> 3) focal plasmacytomas on magnetic resonance imaging (MRI) or diffuse hyperintense signal on short tau inversion recovery (STIR) weighted images Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patients with a poor performance status (3-4) are also eligible after having improved their performance to 0-2 No significant co-morbid medical conditions; no uncontrolled life threatening infection Patient evaluation should be done within 35 days prior to registration; signed informed consent should be obtained from all patients in accordance with institutional and federal guidelines Patients with a history of recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, difficult to control significant cardiac arrhythmias, or arrhythmia associated with prolonged QT interval; left ventricular ejection fraction by echocardiogram or multi gated acquisition scan (MUGA) < 45% assessed within 35 days prior to study registration Patients with a history of moderate to severe chronic obstructive and/or restrictive pulmonary disease, with a forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 50% of the predicted values; diffusing capacity of the lung for carbon monoxide (DLCO) < 50%; partial pressure of oxygen (P02) < 70 mmHg Patients with a prior history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years Pregnant or nursing women; women of child-bearing potential must have a negative pregnancy documented within one week of registration; women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method Human immunodeficiency virus (HIV) positive patients Transaminases > 2 x normal values or bilirubin > 2 x normal values; prior history of chronic liver disease Patients with renal failure on dialysis Active uncontrolled infection History of significant psychiatric illness
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-55.0, Hematologic Malignancies Age: subjects ≥ 18 and ≤ 55 years old. 2. Patients without suitable matched related donor 3. Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option. 4. Written consent form signed Performance status: Eastern Cooperative Oncology Group(ECOG) score >2 Prior allogenic hematopoietic stem cell transplant Left-ventricular ejection fraction at rest < 45%, uncontrolled arrhythmias or symptomatic heart failure Diffusing capacity (DLCO) and/or forced vital capacity (FVC) < 39% of predicted values or symptomatic pulmonary disease Altered liver function tests (total bilirubin > 2 mg/dL and/or alanine aminotransferase, aspartate aminotransferase , and or active hepatitis or cirrhosis Serum creatinine > 2 mg/dL or estimated creatinine clearance < 50 mL/min Evidence of uncontrolled bacterial, viral or fungal infection prior to the conditioning regimen Serious diseases that prevent patients from receiving chemotherapy treatments Concomitant neoplasms Pregnancy or breast-feeding
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Male or female multiple myeloma patients with ≥18 years of age Subjects who understand and voluntarily sign an informed consent Subjects who are receiving lenalidomide treatment in combination with dexamethasone not longer than four weeks Refusal to participate in the study Patients who are currently on an interventional clinical trial Subjects who previously received lenalidomide treatment and whose treatment is ceased or who had a treatment interruption for four weeks or longer
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Shoulder Impingement Syndrome painful arc of movement during flexion or abduction positive Neer or Kennedy-Hawkins impingement signs pain on resisted lateral rotation, abduction or empty can test previous shoulder surgery shoulder pain reproduced by neck movement clinical signs of full-thickness RC tears shoulder capsulitis
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma Age between 18 years Karnofsky status ≥ 70% Diagnosis of Multiple Myeloma Within 9 months of the start of induction chemotherapy and no evidence of relapse or progression Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least 2x106/kg Poor cardiac function: left ventricular ejection fraction <40% Poor pulmonary function: FEV1, FVC, or DLCO <40% predicted Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT > 3X ULN Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance < 40 mL/min (calculated creatinine clearance is permitted) Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 75.0-999.0, Post-operative Cognitive Dysfunction any patient aged 75 years and more scheduled for elective non-cardiac surgery under general anesthesia Failure to obtain informed consent to the study Impossibility to perform scheduled geriatric and neuropsychological tests during the preoperative evaluation Mini-mental state examination score (corrected for age and education) ≤ 23 at the preoperative evaluation Patients scheduled to undergo intracranic neurosurgical procedures or vascular surgery Patients who have been subjected to a surgical procedure under general anesthesia in the preceding 6 months Patients with metastatic cancer; patients falling in the category of the American Society of Anaesthesiologists (ASA) physical status 4 Patients already included in the study, i.e. second surgical procedure; for the Control Group: • Subjects of 75 years and more in whom no hospitalization or surgical procedure is scheduled in the following 3 months for the Control Group Failure to obtain informed consent to the study Impossibility to perform scheduled geriatric and neuropsychological tests during the baseline evaluation
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma Myeloma-Multiple Histologically confirmed diagnosis of myeloma Between 18 and 70 years of age (inclusive) Karnofsky performance status ≥ 50% or ECOG performance score of ≤ 2 -Completion of last anti-myeloma therapy (if any) must occur at least 14 days before conditioning Must have an HLA-matched sibling, HLA-matched unrelated donor, or a related haploidentical donor Available HLA-matched sibling or unrelated donor must meet the following At least 18 years of age HLA donor/recipient match based on at least low-resolution typing per institutional standards (syngeneic donors [identical twins] are excluded) In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting stem cells No active hepatitis Negative for HTLV and HIV Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis Presence of another concurrent malignancy requiring treatment History of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan, cyclophosphamide, or other agents used in the study Presence of an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant and/or breastfeeding Previous treatment with tocilizumab (TCZ) Immunization with a live/attenuated vaccine within 28 days prior to conditioning Any history of recent serious bacterial, viral, fungal, or other opportunistic infections, precluding a stem cell transplant according to the treating physician Serologic evidence of HIV Active infection with Hepatitis A, B, or C. Active infection is defined as serologic positivity and elevated liver function tests
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Kidney Failure, Chronic Arteriovenous Fistulae Incident patients that enter the pre-dialysis program because of end-stage renal failure and need for vascular access Permanent dialysis patients in need of a new VA in the contralateral arm because of a previous failed access Patients in which treatment of first choice is the creation of an autologous AVF Patients with adequate arteries and veins (duplex) for creation of RC-, BC or BBAVF Patients that signed the written informed consent Patients with contraindications for creation of an autologous AVF (skin infection, ischemia, heart failure) Patients with a previous vascular access in the ipsilateral arm
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-85.0, Amyloidosis Paraproteinemias Cardiomyopathies Subjects meeting diagnostic for the target population will be recruited for the study. Age range will be 18 to 85 years of age will history of heart transplantation as well as any contraindications for 1.5T CMR. For the use of GBCA, patients with acute renal failure or stage IV/V chronic renal failure will be excluded. Patients with end stage renal failure receiving peritoneal dialysis will also be excluded. Women who are pregnant or breast feeding will also be excluded
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 65.0-999.0, Leukemia, Myeloid, Acute De novo or secondary acute myeloid leukemia (AML) (post myelodysplastic syndrome [MDS] or myeloproliferative neoplasm [MPN] or after leukemogenic chemotherapy) according to WHO 2008 For Part A Participants With AML: treatment naive or relapsed for whom experimental therapy is appropriate (as assessed by their treating physician) For Part B Greater than or equal to (>=) 75 years of age or >= 65 up to 75 years of age and have at least one of the following: congestive heart failure or ejection fraction less than or equal to (<=) 50 percent; creatinine greater than (>) 2 milligram per deciliter (mg/dL); dialysis or prior renal transplant; documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) <= 65 percent of expected, or forced expiratory volume in 1 second (FEV1) <= 65 percent of expected or dyspnea at rest requiring oxygen; eastern cooperative oncology group (ECOG) performance status of 2; prior or current malignancy that does not require concurrent treatment; unresolved infection; comorbidity that, in the Investigator's opinion, makes the participant unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization Previously untreated AML (except: emergency leukopheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of study therapy) Not eligible for an allogeneic hematopoietic stem cell transplantation ECOG Performance Status score of 0, 1 or 2 A woman must be either: Not of childbearing potential: postmenopausal (more than [>] 45 years of age with amenorrhea for at least 12 months; If, of childbearing potential must be practicing a highly effective method of birth control A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment Acute promyelocytic leukemia with t(15;17), or its molecular equivalent (PML-RARalpha) For Part B only: Known leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system Participants who received prior treatment with a hypomethylating agent For Part A only: Participants who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1 Any uncontrolled active systemic infection that requires treatment with intravenous (IV) antibiotics A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening Active systemic hepatitis infection requiring treatment or other clinically active liver disease
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, AL Amyloidosis Histological diagnosis of primary systemic (AL) amyloidosis based on Deposition of amyloid material by Congo red stain showing characteristic apple green birefringence,AND… evidence of a clonal plasma cell dyscrasia with monoclonal protein in the serum or urine by immunofixation electrophoresis studies AND/OR abnormal serum free light chain assay AND/OR clonal plasma cells in the bone marrow exam demonstrated by immunohistochemistry, flow cytometry or in situ hybridization AND… evidence of organ involvement other than carpal tunnel syndrome. 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. 2. Patients must be > 18 years of age. 3. Patients must have a performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) 4. Patients must have left ventricular ejection fraction (LVEF) > 45% by echocardiogram within 60 days of enrollment 5. Pulmonary Function Tests must show diffusing capacity of lung for carbon monoxide (DLCO) > 50%. 6. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients with recent (< 6 months) myocardial infarction, congestive heart failure, New York Heart Association (NYHA) class III/IV or arrhythmia which are refractory to medical therapy are ineligible. 2. 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 < 300 mg. Patients should not have received any cytotoxic therapy < 4 weeks prior to registration and should have fully recovered from the effects of such therapy. 3. Patients must not have overt multiple myeloma (>30% bone marrow plasmacytosis and, extensive (>2) lytic lesions and hypercalcemia). 4. 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 5 years. 5. Patients must not be HIV positive. 6. Pregnant or nursing women may not participate. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, End-stage Renal Disease Hospitalized in inpatient Nephrology Unit at Henry Ford Hospital Has end-stage renal disease Willing and able to contact support person / family member about participating in the study Persistent Delirium Non-English speaking
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Plasma Cell Leukemia Recurrent Plasma Cell Myeloma Relapsed multiple myeloma in patients that have been treated previously with autologous hematopoietic stem cell transplantation (auto-HCT), bortezomib and an immunomodulatory agent, AND with at least one of the following high-risk High-risk multiple myeloma defined by cytogenetic or fluorescence in situ hybridization (FISH) detection of any one or more of the following Deletion 17p Translocation t(4;14) Translocation t(14;16) Translocation t(14;20) Chromosome 1q gain Chromosome 1p deletion Deletion 13q by conventional karyotyping (FISH only not acceptable) Hypodiploidy Previous allogeneic stem cell transplant POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [protein] and skin changes) Bilirubin > 1.5 x the upper limit of normal Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x the upper limit of normal Patients with >= grade III or grade II with pain peripheral neuropathy (National Cancer Institute [NCI] Common Terminology for Adverse Events [CTCAE] version [v.] 4.03 criteria) Receiving steroids > the equivalent of 10 mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosus, rheumatoid arthritis Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive 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 Second malignancy requiring concurrent treatment or those with non-hematological malignancies (except non-melanoma skin cancers); cancer treated with curative intent < 5 years previously will not be allowed unless approved by the protocol chair; cancer treated with curative intent > 5 years previously is allowed
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Plasma Cell Leukemia Plasmacytoma Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Refractory or relapsed myeloma, defined as one or more of the following Treated with first-line therapy including at least 2 cycles of lenalidomide, bortezomib or thalidomide, and one or more of the following Less than partial response (PR) to first-line therapy Relapse after first (1st) line therapy High-risk cytogenetics, defined by deletion (del)(13q) by conventional cytogenetics, or by del(17p), t(4;14), t(14;16), t(14;20) or 1q+ by fluorescence in situ hybridization (FISH) Relapse after a prior autologous stem cell transplant (ASCT) Plasma cell leukemia Soft tissue plasmacytoma Serum creatinine =< 1.8 mg/dL and/or estimated serum creatinine clearance >= 50 ml/min Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit of normal Prior whole brain irradiation Having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL) Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology Active infection requiring parenteral antibiotics Known positivity for human immunodeficiency virus (HIV) Autologous stem-cell transplant in the previous six months Needing valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-75.0, Allogeneic Stem Cell Transplantation Exercise Intervention Patients hematological malignancy (AML, ALL, MDS, OMF, CML, MM, NHL, Hodgkin, AA) to 6 months after allogeneic HSCT ≥ 18 years of age at time of transplantation German as mother tongue regular follow-up visits at the transplantation center during the first year after transplantation > 75 years of age at time of transplantation relapse/progress thrombocyte count ≤ 50 G/l GvHD with lung involvement compromised lung function (patients who need oxygen) compromised cardiovascular function (< 10-m walk) florid infection immobility neurological disease severe psychiatric disease
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Secondary Hyperparathyroidism Both male and female, aged 18 or older Intact parathyroid hormone(iPTH) is more than 9 times the upper limit of the normal range (about 600pg/ml), with hypercalcemia or hyperphosphatemia Refractory to medical therapy Provided written informed consent Primary or tertiary hyperparathyroidism Familial hyperparathyroidism (MENⅠ, MENⅡ, hereditary HPT) Neck surgical exploration history Parathyroid malignant tumor
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Multiple Myeloma Diagnosis of previously untreated multiple myeloma (MM) Have a confirmed diagnosis and eligible for high dose chemotherapy and autologous stem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2 previous treatment for Multiple Myeloma Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma Prior or concurrent exposure to systemic therapy or SCT (Stem Cell Transplantation) for any plasma cell dyscrasia, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment, or received an investigational drug or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1 history of malignancy (other than Multiple Myeloma) within 10 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Amyloidosis Patients with the following characteristics are eligible for this study: 1. Aged 18 years or greater 2. Diagnosis of systemic AL amyloidosis with of genetic mutations associated with hereditary amyloidosis and immunohistochemical of AA and TTR amyloidosis as appropriate Amyloid related organ dysfunction or organ syndrome 3. Measurable clonal disease 4. Clonal relapse after previous chemotherapy or stem cell transplant OR refractory clonal disease to previous chemotherapy or stem cell transplant 5. Capable of providing written, informed consent and willing to follow study protocol 6. Life expectancy ≥ 6 months 7. ECOG performance status of <3 8. Platelet count ≥ 50x109/l) 9. Neutrophil count ≥ 1x109/l) 10. Haemoglobin ≥ 8g/dL 11. Bilirubin <2 times or Alkaline phosphatase <4 times upper limit of normal. 12. Female participants of child-bearing potential must have a negative pregnancy test prior to treatment and agree to use dual methods of contraception for the duration of the study and for 30 days following completion of study. Male participants must also agree to use a barrier method of contraception for the duration of the study and for 30 days following completion of study if sexually active with a female of child-bearing potential. Participants must comply with the Celgene pregnancy prevention programme for thalidomide Patients with the following characteristics are ineligible for this study: 1. Overt symptomatic multiple myeloma 2. Amyloidosis of unknown or non AL type 3. Localised AL amyloidosis (in which amyloid deposits are limited to a typical single organ, for example the bladder or larynx, in association with a clonal proliferative disorder within that organ) 4. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome). 5. Refractory to or progressive disease with an IMid and proteasome inhibitor combination 6. Allogeneic stem cell transplantation 7. Solid organ transplantation 8. Severe peripheral or autonomic neuropathy causing significant functional impairment. 9. eGFR <20ml/min 10. Ejection fraction < 40% or NYHA class III or IV heart failure or uncontrolled hypertension 11. Pulmonary Hypertension 12. Advanced Mayo stage III disease as defined by hs-Troponin T>0.07 and NT-proBNP >700 pMol/L OR NT-proBNP >1000 pMol/L OR supine SBP <100 mm of Hg 13. Myocardial infarction in the preceeding 6 months or unstable angina or conduction abnormalities uncontrolled by medication or devices 14. Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas 15. Pregnant, lactating or unwilling to use adequate contraception 16. Systemic infection unless specific anti-infective therapy is employed. 17. Known or suspected HIV infection 18. Contraindication to any of the required concomitant drugs or supportive treatments. Any other clinically significant medical disease or condition or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a participant's ability to give informed consent 19. Previous experimental agents or approved anti-tumour treatment within 3 months before the date of registration 20. Known allergies to the IMPs
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, End Stage Renal Disease Peritoneal Dialysis Patients with end-stage renal disease who were undergoing peritoneal dialysis; either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) History of psychological illness or condition that interferes with the ability to understand or comply with the requirements of the study 2. Recent (within 1 month) exit-site or tunnel infection, or peritonitis 3. Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin 4. Current or recent (within 1 month) treatment with antibiotics administered by any route 5. Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant S. aureus
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-999.0, Amyloidosis Primary Amyloidosis Patients with AL amyloidosis at Tufts Medical Center who have baseline bone marrow samples available and achieve a CR or VGPR to treatment. Patients may consent and register at diagnosis and have a baseline marrow collected at the time of consent; or patients may consent during therapy prior to achieving a response, if they have previously banked marrow cells for research Patients who do not have available baseline bone marrow samples
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-99.0, End-stage Renal Disease Informed consent Patients with end-stage renal disease [5] undergoing any modality of renal replacement therapy (hemodialysis, hemodiafiltration or peritoneal dialysis) Malignancy Pregnancy Chronic inflammatory bowel disease Celiac disease Active alcohol abuse (>40g alcohol per day) Any severe organ dysfunction unrelated to renal dysfunction 20 healthy family members (living in the same household) of patients will be recruited as controls
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, AL Amyloidosis Amyloidosis Patients must have AL Amyloidosis
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, End-stage Renal Disease Aged 18 years or more Be diagnosed end-stage renal disease for more than one year Have been regularly received long-term hemodiafiltration for more than 6 months Patients who received hemodiafiltration less than 6 months
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Mucositis Multiple Myeloma Amyloidosis Oral Mucositis Patients with multiple myeloma (MM) or systemic light-chain amyloidosis who are receiving high-dose Melphalan (HDM) and autologous peripheral blood stem cell transplantation (ASCT). 2. Age is greater than 18 years old 3. Patients receiving a total Melphalan dose of 140-200 mg/m2 as the preparative regimen 4. No prior history of allogeneic stem cell transplantation 5. Patients otherwise meeting all standard institutional for ASCT Patients who do not meet
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Age ≥18 years, male or female Diagnosis: multiple myeloma undergoing Autologous Stem Cell Transplantation (SCT) Planning to receive conditioning chemotherapy (Melphalan) for autologous stem cell transplantation and standard prophylactic antibiotics treatment Can drink 200ml of mannitol and agrees to undergo stool, urine, and blood checks 3 times during the study Agrees and able to take the investigational products or placebo starting from the day of completing conditioning therapy for a total of 4 weeks Patients with history of inflammatory bowel disease will be excluded from the study Patients with prior GI tract surgical (small or large bowel) resections The concurrent presence of systemic light chain amyloidosis Subject has known allergy or intolerance to beef or to any ingredient used in the product Women who are pregnant, breast-feeding and of child-bearing potential
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Hemodialysis Arteriovenous Fistula Maturation Failure Age >18 years Patients with ESRD and access dysfunction secondary to stenosis anywhere in the AVF Patients on anti-coagulation and those with bleeding disorders Life expectancy less than 12 months Documented severe contrast allergy Inability to come for timely and adequate follow up Patients undergoing transplantation work up and expected to be transplanted within 6 months AVG with access dysfunction developing within 30 days of surgery AVF with early fistula failure Recurrence of stenosis within 3 months of previous intervention
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, AL Amyloidosis Age ≥18 years 2. Confirmed diagnosis of systemic AL amyloidosis 3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic response 4. Cardiac involvement 5. NT-proBNP ≥650 Non-AL amyloidosis 2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma 3. NT-proBNP >5000 4. Received Plasma cell directed chemotherapy within 6 months 5. Received autologous stem cell transplant (ASCT) within 12 months
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Stenosis of Arteriovenous Dialysis Fistula Age >18 years Patients with EFF Stenosis anywhere in the AVF being the only identifiable cause of EFF Patients with AVF which is deeper than 0.8cm from the skin AVF which is tortuous and lacks adequate straight segment for cannulation with 2 needles Patients with allergy to paclitaxel Patients on anti-coagulation and those with bleeding disorders Severe thrombocytopenia i.e platelet count< 50,000 Life expectancy less than 12 months Documented severe contrast allergy Inability to come for timely and adequate follow up Patients undergoing transplantation work up and expected to be transplanted within 6 months EFF secondary to accessory veins or causes other than stenosis
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-99.0, Amyloidosis, Primary Cardiomyopathy Age > 18 years Diagnosis of light chain amyloidosis by standard (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed) For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study Subjects with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D Willing and able to provide consent Additional for the Remission AL-CMP: Hematological response defined as complete hematological remission or very good partial response-differential free light chain (dFLC)<40 mg/dL for > 1 year prior to enrollment Additional for the Active AL-CMP exercise: Ability to perform supine bicycle exercise. Enrollment to this arm will stop after 36 subjects complete baseline and 6 months studies Additional for the Active AL Pre-CMP Normal left ventricular wall thickness (≤ 12 mm) and normal LVEF (≥55%) on echocardiography within 3 months or increased wall thickness with normal cardiac biomarker levels: not meeting above definition Hemodynamic instability Decompensated heart failure (unable to lie flat for 1 hour) Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy) Known obstructive epicardial coronary artery disease with stenosis > 50% in any single territory Severe claustrophobia despite use of sedatives Presence of MRI contraindications such as metallic implants (pacemaker or ICD) at the time of study enrollment except for Control Heart Failure subjects. Control HF subjects with no devices, or, with strictly MR compatible devices will be eligible to undergo MRI Significant renal dysfunction with estimated glomerular filtration rate < 30 ml/min/m2 within 14 days of each cardiac MRI study. Subjects who develop renal dysfunction over the course of the study, meeting listed above, will be excluded from the cardiac MRI scan except for control HF subjects. These subjects with eGFR < 30 ml/min/1.73 m2 will undergo MRI without gadolinium contrast Subjects on dialysis will be excluded Pregnant state. For women in child bearing age, a urine pregnancy test will be performed prior to the PET and the cardiac MRI studies Documented allergy to F-18 florbetapir, C-11 acetate or gadolinium
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma in Relapse Multiple Myeloma Signed informed consent document Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks)
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Amyloidosis Biopsy-proven systemic AL amyloidosis defined as At least one + Congo Red stain Proof of a clonal plasma cell dyscrasia by Immunofixation electrophoresis (IFE) of the urine or serum Light chain restriction based on Immunohistochemistry (IHC) in bone marrow plasma cells or in the amyloid tissue Must be scheduled to undergo antineoplastic therapy (this may high dose melphalan and Autologous Stem Cell Transplantation) for AL Amyloidosis (Part II enrollments only) Co-existing Multiple Myeloma Prior antineoplastic treatment for AL amyloidosis at time of enrollment Prior negative bone marrow biopsy showing no identifiable clone
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-74.0, Hodgkin's Lymphoma Leukemia Lymphoid Leukemia Multiple Myeloma Myeloid Leukemia Non-hodgkin's Lymphoma Myelodysplastic Syndrome Adults 18 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) at the University of Wisconsin Carbone Cancer Center (UWCCC) Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin's and Non-Hodgkin's types) receiving standard conditioning regimens Allogeneic transplant recipients undergoing fully ablative transplants Participants who develop treatment complications or disease recurrence after being enrolled in the study may continue to participate if they are able to do so Autologous transplant recipients receiving non-standard regimens Autologous transplant recipients with diagnoses other than multiple myeloma or lymphoma Allogeneic transplant recipients receiving reduced intensity regimens
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-75.0, Acute Leukemia Acute Myeloid Leukemia Acute Lymphoblastic Leukemia/Lymphoma Burkitt's Lymphoma Natural Killer Cell Malignancies Chronic Myelogenous Leukemia Myelodysplastic Syndrome Large-cell Lymphoma Hodgkin Lymphoma Multiple Myeloma Relapsed Chronic Lymphocytic Leukemia Relapsed Small Lymphocytic Lymphoma Marginal Zone B-cell Lymphoma Follicular Lymphoma Lymphoplasmacytic Lymphoma Mantle-cell Lymphoma Prolymphocytic Leukemia Bone Marrow Failure Syndromes Myeloproliferative Neoplasms/Myelofibrosis Biphenotypic/Undifferentiated/Prolymphocytic Leukemias MRD Positive Leukemia Leukemia or MDS in Aplasia Relapsed T-Cell Lymphoma Relapsed Multiple Myeloma Plasma Cell Leukemia Age, Performance Status, and Graft <70 years of age with no matched 5/6 or 6/6 sibling donor patients ≥ 70 and ≤ 75 years of age may be eligible if they have a Co-Morbidity score ≤ 2 (http://www.qxmd.com/calculate-online/hematology/hct-ci) Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (< 16 years) UCB graft selected according to current University of Minnesota umbilical cord blood graft selection algorithm Eligible Diseases All diseases listed below are advanced hematologic malignancies not curable by conventional chemotherapy. Responses to conventional treatment range from zero to 30% but are typically short lived Acute Leukemias: Must be in remission by morphology (<5% blasts). Note cytogenetic relapse or persistent disease without morphologic relapse is acceptable. Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk. Favorable risk AML is defined as having one of the following t(8,21) without cKIT mutation inv(16) or t(16;16) without cKIT mutation Pregnant or breast feeding. The agents used in this study Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy Untreated active infection Active HIV infection or known HIV positive serology Less than 3 months since prior myeloablative transplant Evidence of progressive disease by imaging modalities or biopsy persistent PET activity, though possibly related to lymphoma, is not an criterion in the absence of CT changes indicating progression CML in blast crisis Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy Active central nervous system malignancy
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Multiple Myeloma Initial 1. Patients must be considered transplant eligible by the treating physician at time of study entry. 2. Patients must meet the for symptomatic multiple myeloma prior to initiating systemic anti-myeloma treatment. 3. Age >18 years and ≤ 70 years at the time of enrollment 4. Karnofsky Performance status of ≥ 70% 5. Patients must have > 20% plasma cells in the bone marrow aspirate differential <60 days prior to enrollment. The required bone marrow evaluation will need to be repeated for patients who received more than 1 cycle of anti-myeloma therapy (corticosteroid with or without other anti-myeloma agents) 6. Patients must have received ≤ 1 cycles of systemic anti-myeloma therapy. 7. Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated. Initial Patients with a prior autologous or allogeneic HCT 2. 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 and the absence of involved serum free light chain >100 mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible. 3. Patients with Plasma Cell Leukemia 4. Patients with disease progression prior to enrollment 5. Patients seropositive for the human immunodeficiency virus (HIV). 6. Myocardial infarction within 6 months prior to enrollment or 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 will be documented by the investigator as not medically relevant. 7. Patients with active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible. 8. Patients receiving other investigational immunotherapy or anti-myeloma drugs within 14 days before enrollment. 9. Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < 5 years prior to enrollment will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent > 5 years prior to enrollment is allowed. 10. Female patients who are pregnant (positive beta-HCG) or breastfeeding. 11. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques (Appendix D) during the length of lenalidomide maintenance therapy. 12. Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy. 13. Prior organ transplant requiring immunosuppressive therapy. 14. Patients who previously received lenalidomide and have experienced toxicities resulting in treatment discontinuation. 15. Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide. 16. Patients unwilling to take deep vein thrombosis (DVT) prophylaxis. 17. Patients unable or unwilling to provide informed consent. 18. Patients unable or unwilling to return to the transplant center for their assigned treatments. Randomization 1. Patient received transplant < 12 months of enrollment onto BMT CTN 1401. 2. No disease progression since initiation of systemic anti-myeloma therapy as determined within seven days of randomization/enrollment. 3. Received an autologous cell transplant with melphalan 200mg/m^2 with a minimum cell dose of 2x10^6 CD34+ cells/kg (actual body weight). 4. Mucositis and gastrointestinal symptoms resolved, off hyperalimentation and intravenous hydration. 5. No evidence of uncontrolled infection requiring systemic therapy. Patients who completed treatment for an infection but are continuing antibiotics, anti-viral, or anti-fungal therapy for prophylaxis are eligible to continue on protocol. 6. Platelet count ≥75,000/mm^3 (without transfusion in previous 7 days). 7. Absolute neutrophil count (ANC) ≥ 1,500/mm^3 without filgrastim administration within 7 days, or pegfilgrastim within 14 days of measurement. 8. Hepatic: bilirubin < 2x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 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 2x the upper limit of normal) 9. Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated. Patients with creatinine clearance ≥30 but <40 will be considered with review/approval from the protocol chairs or officer if the cause of renal insufficiency is associated with multiple myeloma. 10. All study participants must be registered into the mandatory Revlimid REMs program, and be willing and able to comply with the requirements. 11. Females of childbearing potential (FCBP) as defined in section 2.7.1.1 must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) 12. FCBP must either commit to abstain continuously from sexual intercourse or use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of lenalidomide. 13. FCBP must agree to ongoing pregnancy testing as required by the Revlimid REMs program. 14. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy while taking lenalidomide, during dose interruptions and for 28 days after discontinuing lenalidomide. 15. Patients must be willing to receive DVT prophylaxis
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Newly-diagnosed multiple myeloma who are treated with Revlimid Capsules N/A
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Hyperphosphatemia End-stage Renal Disease End-stage renal disease patients whose dialysis vintage is more than 3 months Patients with liver cirrhosis Pregnant patients Patients with alimentary tract malabsorption diseases History of recent alcohol or drug abuse Patients receiving chemotherapy for solid organ tumor History of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.) Patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-75.0, Multiple Myeloma Amyloidosis Symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (less than 5 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD (vincristine, adriamycin and dexamethasone) regimen Patient must be aged 18-75 years, with an ECOG (Eastern Cooperative Oncology Group) < 3, and has given voluntary written informed consent Patient has the following laboratory values at baseline Platelets count > 50 x 109/l without transfusion support within 7 days before the laboratory test Absolute neutrophil count (ANC) > 1.0 x 109/l without the use of colony stimulating factors Creatinine-clearance > 40 ml/min Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months. No pregnant or lactating patients are allowed Patients with more than 4 cycles of chemotherapy with lenalidomide Patients not fit for autologous stem cell transplantation Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery Subject is currently enrolled in another investigational trial or is receiving other investigational agent(s)
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Have received at least 1 and no more than 3 prior lines of therapy for multiple myeloma Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 The toxicities resulting from previous therapy must be resolved or stabilized to less than or equal (<=)Grade 1 prior to drug administration A woman of childbearing potential must have a negative highly sensitive serum (human chorionic gonadotropin [hCG]) or urine pregnancy tests at screening within 14 days prior to Cycle 1 Day 1 Have documented evidence of progressive disease/disease progression based on investigator's determination of response by the International Myeloma Working Group (IMWG) on or after their last regimen Received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day (mg/day) for a maximum of 4 days) before treatment Received autologous stem cell transplant (ASCT) within 12 weeks before the date of randomization, or the participant has previously received an allogenic stem cell transplant (regardless of timing) Plans to undergo a stem cell transplant prior to progression of disease on this study, that is, these participants should not be enrolled in order to reduce disease burden prior to transplant Is known to be infected with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C Had 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 clinically significant conduction system abnormalities
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with symptomatic MM as defined by IMWG requiring anti-myeloma therapy Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma Monoclonal protein present in the serum and/or urine Creatinine clearance < 30 mL/min, not eligible for bisphosphonate. Estimated glomerular filtration rate will be calculated using Cockcroft-Gault equation Serum calcium or albumin-adjusted serum calcium ≥ 2.1 mmol/L (8.4 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL) (Reference range 8.5-10.8 mg/dL) Able to tolerate daily supplementation of calcium and vitamin D Vitamin D level ≥ 30 ng/mL after repletion Participants must have normal organ as defined below Total bilirubin ≤ 2.0 x ULN AST(SGOT) ≤2.5 × institutional upper limit of normal Prior administration of denosumab Active IV bisphosphonate use in the last 3 months POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) Plasma cell leukemia Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw Active dental or jaw condition which requires oral surgery, including tooth extraction Non-healed dental/oral surgery, including tooth extraction Planned invasive dental procedures during the course of study Evidence of any of the following conditions per subject self-report or medical chart review Any prior invasive malignancy within 5 years of enrollment that may affect outcome of study
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Patients of both genders, aged equal or more than 18 years. 2. Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria. 3. Patients with documented renal damage defined as creatinine clearance <50 ml / min / 1.73 m2 (CrCl <50ml / min / 1.73m2). 4. Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice *. 5. Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent). 6. Subject with any of the following characteristics (at least one of the 2 following options must be Yes) Subjects who have not previously participated in the study Subjects who have previously participated in the study, who meet all the again and to whom none of the apply, and whose current relapse is consecutive to the relapse that prompted their initial in the study The decision to prescribe treatment will be clearly dissociated from the decision to the patient in the study Clarification is provided as to the aim of the study, which is to encompass all relapse subcategories included in the International Myeloma Working Group consensus document published in 2006. Therefore, all patients with clinically relapsed multiple myeloma, who are in relapse following a complete response or in progression (including refractory cases) as defined in point 8.1 and in table 4 of the protocol, are considered eligible candidates for participation in the EPA-MIR 50 study, as long as they meet all the other Patients who are participating in an interventional clinical trial * or who refuse to participate in the study. 2. Patients with CrCl <50 ml / min / 1.73m2 due to a cause other than multiple myeloma properly documented at the discretion of the investigator * The of patients who are participating in another observational study is permitted
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-95.0, Multiple Myeloma Multiple myeloma diagnosis Diagnosis before 1st january 2008
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Plasma Malignancy Patients must have a diagnosis of multiple myeloma or related malignancy 2. Patients are undergoing standard of care bone marrow aspirates 3. Patients (male or female) from any race or ethnicity must be at least 18 years of age at the time of registration. 4. Procedure-specific signed informed consent form prior to initiation of any study-related procedures It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo a bone marrow aspirate. 2. Patients who are incarcerated are not eligible to participate. 3. Women who are pregnant 4. Patients who have had another malignancy within the last five (5) years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix) where there is a possibility to contaminate the bone marrow aspirate
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-110.0, Quality of Life Multiple Myeloma Previously untreated or relapsed multiple myeloma patients AND Treatment demanding multiple myeloma disease Inability to understand the Danish language or Psychic or mental illness that prevents the patient from answering the questions in the questionnaires
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-999.0, End Stage Renal Failure End Stage Renal Failure Refusal to participate
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-75.0, Multiple Myeloma Amyloidosis Age ≥18 and ≤ 75 Patients must have either Symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease): Patients who are receiving high-dose melphalan and AHCT as part of their initial therapy require at least a partial response (PR) as defined by the International Myeloma Working Group uniform response for MM. Patients who are receiving high-dose melphalan and AHCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease. There is no limit on the number of prior regimens received by the patient. OR Light chain (AL) amyloidosis who may be newly diagnosed or previously treated Histologic and serologic findings, reviewed at MSKCC, confirming the diagnosis of multiple myeloma or AL amyloidosis. Standard diagnostic for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines Patients must have at least 3 x 10^6 CD34+ cells/kg frozen Adequate organ function is required, defined as follows Serum bilirubin ≤ 2.0 mg/dl AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal Creatinine clearance ≥ 40 ml/min (24 hour urine collection) 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 Light chain (AL) amyloidosis patients with Mayo Cardiac Stage IIIB (defined as NT-proBNP>8500 ng/L and Cardiac troponin (cTnT) >0.035 μg/L) 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 CE 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 Any known allergy or allergic reactions to Captisol
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 0.0-999.0, Multiple Myeloma All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study Not Applicable
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-65.0, Microtransplantation Autologous Stem Cell Transplantation Multiple Myeloma in Relapse Diagnosis MM compliance with IMWG diagnostic criteria(2014) 2. induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR 3. KPS ≥60，ECOG≤2 4）Age 18-65，eligible for SCT 5）Heart function < II level (NYHA standard) and ejection fraction > 50% - KPS<60 2. Allergy to bortezomib,epirubicin, or drug ingredients 3. Severe hepatitis and organ dysfunction: a serious infection has not been controlled; cardiac ejection fraction <50%, serum bilirubin >3mg/dl, severe abnormal results of liver function test (AST is greater than 3 times the upper limit), severe renal injury; central nervous system disorders, uncontrolled mental illness 4. With more than 2 bortezomib associated with peripheral neuropathy or neuralgia patients 5. Patients with active stage of the herpes zoster 6. Women in pregnancy or lactation 7. MM with AL or EM plasma cell tumor 8. The patient refused to accept the above treatment and signature 9. Donor does not meet the requirements: including HIV positive, active hepatitis B, bone marrow disease, donor refused to provide hematopoietic stem cells and do not agree to sign. 10. Epirubicin / other anthracyclines previously accumulated more than 240mg/m2 -
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, AL Amyloidosis Histologic diagnosis of AL amyloidosis, confirmed by positive Congo red stained biopsy, with evidence of measurable clonal disease according that requires active treatment Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 Relapsed or refractory after at least 1 prior therapy for AL amyloidosis and, in the investigator's opinion, require further treatment. Participants with a history of autologous stem cell transplantation must have adequate blood counts independent of growth factor support and have recovered from any transplant-related toxicities and be at least 100 days post-autologous transplant Less than 30% plasma cells in the bone marrow biopsy and no bone lesions or hypercalcemia The pre-screening test of CD138+ patient marrow plasma cells must show that the patient's CD138+ plasma cells have an apoptosis ratio of Venetoclax treated over untreated cells of greater than 1.4 Objective, measurable organ involvement. Skin purpura, carpal tunnel syndrome, or the presence of vascular amyloid on a bone marrow biopsy alone are not sufficient to meet for "symptomatic organ involvement". Patients may have any of the following amyloid-related organ involvement as defined below: 1. Renal: albuminuria higher than 0.5 g/day in a 24-hour urine collection. 2. Cardiac: involvement is defined as the presence of a mean left ventricular wall thickness on echocardiogram more than 12 mm in the absence of a history of hypertension or valvular heart disease, or unexplained low voltage (< 0.5 mV) on electrocardiogram; or an NT-proBNP > 332 ng/L in CKD 1 or 2 patients or a BNP > 100ng/L in those who are CKD3. 3. Hepatic: hepatomegaly on physical examination with alkaline phosphatase > 1.5 X the upper limit of normal (ULN). 4. Autonomic or peripheral neuropathy: based on clinical history, autonomic dysfunction with orthostasis, symptoms of nausea or dysgeusia, gastric atony by gastric emptying scan, diarrhea or constipation, or abnormal sensory and/or motor findings on neurologic examination AL Amyloidosis Cardiac Risk stage I, II or IIIa disease. Staging system defined by: NT-proBNP cut off of < 332 pg/mL and troponin I cut-off of < 0.10 ng/mL as thresholds for stages I, II and III; NT-proBNP < 8500 for stage IIIa. 1. Stage I, both under threshold; 2. Stage II, either troponin or NT-proBNP [but not both] over threshold; 3. Stage III, both over threshold; 4. Stage IIIa, both over threshold but NT-proBNP < 8500 pg/ml Clinical laboratory values as specified below before the first dose of study drug: 1. Echocardiographic ejection fraction > 45% within 28 days before the first dose of study drug. 2. Within the 3 days of the first dose of study drug: i. Platelet count > 75 x 109/L; ii. Neutrophil count > 1.0 x 109/L; iii. Total bilirubin < 2 x ULN; iv. Alkaline phosphatase < 5 x ULN; v. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x ULN; vi. eGFR > 30 mL/min/1.73 m2 Female patients who are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR, if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse Male patients, even if surgically sterilized (ie, status post vasectomy), who agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, OR agree to completely abstain from heterosexual intercourse Treatment with any investigational products within 28 days before the first dose of study drug Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered to be investigational Failure to have fully recovered (ie, > Grade 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment Active fungal infection requiring continued therapy Cardiac system: 1. QTc > 470 milliseconds (msec) on a 12 lead ECG obtained during the Screening period. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG. 2. AL Amyloidosis Risk Stage IIIb disease. Stage IIIb is defined by NT-proBNP > 8500 pg/mL and troponin I > 0.10 ng/mL. 3. New York Heart Association (NYHA) classification III or IV. 4. Enzyme-documented myocardial infarction within 6 months before enrollment. 5. Chronic atrial fibrillation. 6. Grade 2 or 3 atrioventricular (AV) block (Mobitz, Type I permitted). 7. Supine systolic blood pressure < 90 mmHg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure on standing of > 20 mm Hg in spite of being treated for orthostatic hypotension. 8. History of a bleeding diathesis or currently receiving treatment with warfarin. Patients are allowed to take aspirin GI system: 1. Severe diarrhea (= Grade 3) not controllable with medication (such as octreotide) or requires administration of total parenteral nutrition. 2. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of study drug, including difficulty swallowing Neurologic/ Social system: 1. Patients with > Grade 2 peripheral neuropathy or painful peripheral neuropathy on clinical examination will be excluded. 2. Previous or ongoing psychiatric illness. 3. Social situations that would limit compliance with study requirements Systemic infections: 1. Known to be human immunodeficiency virus (HIV)-positive. 2. Known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. 3. Uncontrolled infection requiring systemic antibiotics Clinically overt multiple myeloma (bone marrow plasma cells > 30%) and bone lesions or hypercalcemia Patients with non-AL amyloidosis
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-100.0, Amyloidosis Adults: 18-100 Pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed non-amyloid causes of peripheral neuropathy Metallic devices that are not MR safe (cardiac pacers, stents, aneurysm coils, etc.) Claustrophobia BMI over 38
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Endstage Renal Disease Age 1. ≥45 years or 2. ≥18 with a history of diabetes 2. On dialysis ≥ 90 days 3. On either 1. Hemodialysis prescribed at least 2 treatments per week or 2. Peritoneal dialysis prescribed with at least 1 exchange daily 4. Provides informed consent Hyperkalemia 1. Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or 2. Serum potassium >6.0 mmol/L during active run-in 2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone). 3. Known sensitivity or allergy to spironolactone 4. Current or planned pregnancy or breastfeeding 5. Scheduled living related donor renal transplant 6. Life expectancy < 6 months in the opinion of a treating nephrologist. 7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone. 8. Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 14.0-55.0, AML Age of 14 to 55 years old; 2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML after consolidation regimen. 3. Patients who had received induction and consolation therapy and reached CR. 4. ECOG score of ≤ 2; 5. Patients with eligible laboratory examination including liver,renal and heart function. 6. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent Secondary leukemia. 2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor. 3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, undiagnosed MDS or MPD patients are included. 4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 5. With BCR-ABL fusion gene; 6. Pregnant or lactating women; 7. With ineligible renal or liver function; 8. With active cardiovascular disease; 9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis; 10. AIDS; 11. Patients had central nervous system involvement when they were diagnosed as AML. 12. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research. 13. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results. 14. Patients with other factors which were considered unsuitable to participate in the study by the investigators
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-80.0, Amyloidosis Between 18 and 80 years of age inclusive, at the time of signing the informed consent Male and female. Males: Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication for a cycle of spermatogenesis following five terminal half-lives after the last dose of study medication. Vasectomy with documentation of azoospermia. Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant, Intrauterine device or intrauterine system, Combined Oral Contraceptive or Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches . This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Females A female subject is eligible to participate if she is not pregnant (as confirmed by a negative Urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as: 60 years old; Twelve(12) months of spontaneous amenorrhea with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g. leuprolide treatment) in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (As mentioned in study protocol) from 30 days prior to the first dose of study medication and until 3 months after the last dose of study medication. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Late-Gadolinum enhancement (LGE) on CMR indicative of cardiac amyloidosis LV mass on CMR > 200 grams (g) for Group 1 Transthyretin amyloid (ATTR) cardiomyopathy (CM) Subjects with a diagnosis of hereditary ATTR amyloidosis should have a known amyloidogenic transthyretin (TTR) mutation demonstrated by genotyping AND is recognised to be primarily associated with cardiomyopathy AND one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. Or Scintigraphy: 99m^Tc-DPD with Grade 2 cardiac uptake or 99m^Tc-PYP with either Grade 2 or 3 cardiac uptake Subjects with a diagnosis of wild type ATTR-CM must be negative by genotyping and have one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR Scintigraphy 99m^Technetium-dicarboxypropane diphosphonate (99m^Tc-DPD) with Grade 2 cardiac uptake or 99m^ Technetium-pyrophosphate (99m^Tc-PYP) with Grade 2 or 3 cardiac uptake Clinically stable in New York heart association (NYHA) class 2 or 3 for the 3 months preceding screening for Group 2 Subject medically diagnosed with AL amyloidosis that has required chemotherapy or an autologous stem cell transplant based upon: AL amyloidosis confirmed by biopsy with immunohistochemical staining or proteomic identification of AL amyloid fibril type, in subjects with definite monoclonal gammopathy in whom causative mutations of all known relevant amyloidogenic genes have been excluded Cardiomyopathy primarily caused by non-amyloid diseases (e.g. ischemic heart disease; valvular heart disease) Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) > 500 millisecond (msec) Sustained / symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at screening Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening. Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at screening N-terminal pro b-type Natriuretic Peptide [(NT)-proBNP] >8500 nanograms (ng)/ Liter (L) Glomerular filtration rate (GFR) at Screening < 40 milliliter (mL)/minute (min) Any active and persistent dermatological condition Existing diagnosis of any type of dementia History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation, during the course of the study Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Chronic Kidney Disease Hemodialysis Hypertension Age > 18 years Dialysis vintage > 3 months A history of hypertension, confirmed by valid Home BP readings Written consent to take part in the study Cancer or other advanced non cardiac disease or co-morbidity (e.g. end-stage liver failure) imposing a very poor short-term prognosis Active infections or relevant inter-current disease Inadequate lung scanning and echocardiographic studies Hemodynamic instability during dialysis session that require intravenous fluid administration to restore BP, in over 30% of sessions during the past 3 months Patients with modification of their dry weight and antihypertensive treatment during one month prior to study enrolment Nonfunctional arteriovenous fistula in the contralateral arm of the one used as vascular access for the hemodialysis session Patients with Home BP readings >180/110 mmHg Patients with history of drug or alcohol abuse or known severe mental disorder Pregnancy at study entry or during study period
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