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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): 18.0-90.0, Septic Shock Hyperlactatemia Peripheral Perfusion Septic shock diagnosed at ICU admission according to the Sepsis-3 Consensus Conference, (basically septic patients with hypotension requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg, and serum lactate levels > 2 mmol/l after initial fluid resuscitation with at least 20/ml kg in one hour Pregnancy Anticipated surgery or dialysis procedure during the first 8h after septic shock diagnosis Do-not-resuscitate status Child B or C liver cirrhosis Active bleeding Acute hematological malignancy Severe concomitant acute respiratory distress syndrome (ARDS) More than 4h after officially meeting septic shock
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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 years old or older Have an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m2 Able to read and understand English without an interpreter Diagnosed with chronic kidney disease on record Patients with renal transplant or on dialysis Patients who have documented or provider known cognitive impairment or vision impairment that will prohibit meaningful interaction with education activation worksheet Patients who are not aware of their CKD diagnosis
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-66.0, Myeloma Multiple 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): 1.0-14.0, B-Cell Leukemia B-Cell Lymphoma Relapsed or refractory CD19+ B-cell lymphoma or leukemia. 2. Measurable disease. 3. Karnofsky/jansky score of 60% or greater. 4. ≥1 years old and ≤14 years. 5. Fertile females/males. 6. Expected survival>12 weeks. 7. Histologically confirmed as CD19/20-positive ALL/NHL and who meet one of the following conditions: 1. Patients receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR. 2. Recurrent disease and not eligible for allogeneic stem cell transplantation, and stable disease after therapy but refused further treatment. 3. Disease recurrence after stem cell transplantation. 4. Diagnosis as lymphoma, and refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy. 8. Creatinine < 2.5 mg/dl. 9. Alanine transaminase (ALT) <3x upper limit of normal (ULN), aspartate aminotransferase (AST) <3x ULN. 10. Bilirubin < 2.0 mg/dl. 11. Adequate venous access for apheresis, and no other contraindications for leukapheresis. 12. Take contraceptive measures before recruit to this trial. 13. Written voluntary informed consent is given A history of mental illness and poorly controlled. 2. Patients with symptoms of central nervous system. 3. Suffering severe cardiovascular or respiratory disease. 4. Accompanied by other malignant tumor. 5. Known human immunodeficiency virus (HIV) infection. 6. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). 7. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. 8. Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration. 9. Patients that do not consent to tissue and blood sample collection and storage in a biobank. 10. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed 48 hours before infusion. 11. Pregnancy and nursing females
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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 Leukemia in Remission Plasma Cell Myeloma Patients with will be eligible if they are either in partial response, or have stable disease after no more than two attempts of induction therapy Patients with high-risk cytogenetics, t(4:14); t(14;16), t(14:20), deletion p17, gain in 1q, are eligible Patients with plasma cell leukemia in >= partial remission are eligible Patients with non-quantifiable monoclonal proteins are eligible provided they meet other for multiple myeloma and they have evaluable or measurable disease by other (radiographic, magnetic resonance imaging [MRI], computed tomography [CT], lytic measurable lesion on x-ray,) means Karnofsky performance status (KPS) >= 70% Less than 12 months since diagnosis No contraindication to the collection of a minimum of 4 x 10^6 CD34+ cells/kg by apheresis Bilirubin =< 1.5 mg/dl Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x upper limits of normal Creatinine of measured or calculated creatinine clearance of >= 50 cc/min Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapy Known hypersensitivity to filgrastim or to Escherichia coli (E. coli) derived proteins Inability to lie supine in a full body cast for approximately 30 minutes, the anticipated duration of each treatment session Previous radiation therapy to more than 20% of bone marrow containing areas, or to any area exceeding 2000 cGy, is an Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded No other medical, or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
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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 to enroll in this study. 1. Has a diagnosis of MM based on standard as follows: Major 1. Plasmacytomas on tissue biopsy. 2. Bone marrow plasmacytosis (greater than 30% plasma cells). 3. Monoclonal immunoglobulin spike on serum electrophoresis IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL or kappa or lambda light chain excretion greater than 1 g/day on 24 hour urine protein electrophoresis. Minor 1. bone marrow plasmacytosis (10% to 30% plasma cells) 2. monoclonal immunoglobulin present but of lesser magnitude than given under major 3. lytic bone lesions 4. normal IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL Any of the following sets of will confirm the diagnosis of multiple myeloma any 2 of the major major criterion 1 plus minor criterion 2, 3, or 4 major criterion 3 plus minor criterion 1 or 3 minor 1, 2, and 3, or 1, 2, and 4 2. Currently has MM with measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or urine monoclonal protein levels of at least 200mg/24 hours for patients without measurable serum and urine M-protein levels, an involved SFLC > 100 mg/L or abnormal SFLC ratio 3. Currently has progressive MM MM patients that are relapsed or have refractory disease from at least 2 regimens or lines of therapy including an IMID and a proteasome inhibitor, are eligible for enrollment provided they fulfill the other • Patients are considered relapsed, when they progress greater than 8 weeks from their last dose of treatment Patients are refractory when they progress while currently receiving the treatment or within 8 weeks of its last dose. 4. Previous exposure to lenalidomide independent of the response 5. The patient is not a candidate for a transplant 6. Understand and voluntarily sign an informed consent form before receiving any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn at any time without prejudice to their future medical care. 7. Able to adhere to the study visit schedule and other protocol requirements 8. ECOG performance status of ≤ 2 at study entry 9. Life-expectancy of greater than 3 months 10. Laboratory test results within these ranges at Screening and confirmed at enrollment prior to drug dosing on Cycle 1, Day 1 Absolute neutrophil count ≥ 1.5 x 10E9/L; if the bone marrow is extensively infiltrated ( ≥ 70% plasma cells) then ≥ 1.0 x 10E9/L Subjects meeting any of the following are not to be enrolled in the study: 1. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Plasma cell leukemia (> 2.0 × 10E9/L circulating plasma cells by standard differential) 3. Primary amyloidosis 4. Non-hematologic malignancy within the past 5 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 5. Impaired cardiac function or clinically significant cardiac diseases, including any one of the following Myocardial infarction within 6 months prior to enrollment New York Heart Association (NYHA) Class II or greater heart failure or uncontrolled angina Clinically significant pericardial disease Severe uncontrolled ventricular arrhythmias Echocardiogram or MUGA evidence of LVEF below institutional normal within 28 days prior to enrollment 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. 6. Severe hypercalcemia, i.e., serum calcium ≥ 12 mg/dL (3.0 mmol/L) corrected for albumin 7. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form 8. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study 9. Undergone major surgery within 28 days prior enrollment or has not recovered from side effects of such therapy (vertebroplasty or kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a subject with a recent history of kyphoplasty with the medical monitor). 10. Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide) 11. Received the following prior therapy Chemotherapy within 3 weeks of study drugs Corticosteroids (>20 mg/daily prednisone or equivalent) within 3 weeks of study drugs to ensure that steroid dose intensity at the beginning of the treatment is not altered by administration of steroids prior to the study. Consumption of steroids within 3 weeks of the treatment may interfere with efficacy and side effects due to differences of steroid intensity
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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): 0.0-21.0, Severe Sickle Cell Disease Bone Marrow Failure Syndromes Metabolic Disorders Immunologic Disorders Hemoglobinopathies Non-malignant Disorders Nonmalignant disorder requiring bone marrow transplant including bone marrow failure syndromes, metabolic disorders, immunologic disorders, or hemoglobinopathy For patients with sickle cell disease, must have one of the following severe manifestations: 1. Overt or silent stroke or persistently elevated transcranial doppler velocities despite transfusion therapy 2. Recurrent acute chest syndrome with significant respiratory compromise each time 3. Sickle nephropathy 4. Recurrent admissions for vaso-occlusive episodes resulting in prolonged opioid use and poor quality of life with interrupted school attendance activity 5. Red cell alloimmunization with the need for chronic transfusions 6. Recurrent osteonecrosis or multiple joint involvement from avascular necrosis Patients with sickle cell disease must have hemoglobin S < 30% within 30 days prior to beginning alemtuzumab Age </= 20.99 years at the time of enrollment Performance score > 50 Left ventricular ejection fraction > 40% or left ventricular shortening fraction > 26% by echocardiogram DLCO > 40% (corrected for hemoglobin) or pulse oximetry with a baseline O2 saturation of >/= 90% on room air if too young to perform PFTs Serum creatinine < 1.5x upper limit of normal for age and/or GFR > 70 mL/min/1.73m2 Direct bilirubin < 2x upper limit of normal for age ALT and AST < 5x upper limit of normal for age Patients who have an HLA-identical sibling who is able and willing to donate bone marrow Patients with cirrhosis or established bridging fibrosis of the liver or active hepatitis Uncontrolled bacterial, viral, or fungal infection within 6 weeks prior to enrollment Evidence of HIV infection or known HIV positive serology Patients who have received a previous stem cell transplant Patients who have received an investigational drug or device or off-label use of a drug or device within 3 months of enrollment Females who are pregnant or breast feeding Patients with active autoimmune disease (e.g. sarcoidosis, lupus, scleroderma)
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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): 21.0-99.0, Relapse and / or Refractory Myeloma Multiple myeloma, diagnosed according to standard with relapsing and refractory disease at study entry 2. Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment) 1. Serum M-protein ≥ 0.5g/dL, or 2. In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio 3. Must receive at least 1 line of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment) 4. Must have relapsed disease and/or be refractory to prior treatment except for thalidomide or lenalidomide. Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the of IMWG 5. Males and females ≥ 18 years of age or > country's legal age for adult consent 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 7. Patients must meet the following clinical laboratory with 21 days of starting treatment: 1. Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%) 2. Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN. 3. Calculated creatinine clearance ≥ 30mL/min. 8. Written informed consent in accordance with federal, local and institutional guidelines Female patients who are lactating or pregnant 2. Multiple Myeloma of IgM subtype 3. Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained 4. POEMS syndrome 5. Plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L 6. Waldenstrom's Macroglobulinaemia 7. Existing peripheral neuropathy of grade 2 or higher or presence of neuropathic pain 8. Patients with known amyloidosis 9. Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting Dara-TD treatment 10. Focal radiation therapy within 7 days prior to start of Dara-TD. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide 11. Immunotherapy (excluding steroids) 21 days prior to start of Dara-TD 12. Major surgery (excluding kyphoplasty) within 28 days prior to start of Dara-TD 13. Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained 14. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed) 15. Patients with known cirrhosis 16. Patients with creatinine clearance <30m/min 17. Second malignancy within the past 3 years except: 1. Adequately treated basal cell or squamous cell skin cancer 2. Carcinoma in situ of the cervix 3. Breast carcinoma in situ with full surgical resection 18. Patients with myelodysplastic syndrome 19. Patients with steroid or thalidomide hypersensitivity 20. Patients previously treated with daratumumab or other anti-CD38 antibodies. 21. Ongoing graft-versus-host disease 22. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting Dara-TD treatment 23. Disease refractory to thalidomide or lenalidomide 24. Contraindication to any of the required concomitant drugs or supportive treatments 25. Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
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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, Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant) The for Phase I (primary objective) are as follows Age ≥ 18 years Hematologic malignancy diagnosis including any subset of myeloma, lymphoma, leukemia, or myelodysplastic syndrome Currently scheduled for autologous or allogeneic transplant at the Hospital of the University of Pennsylvania The for Phase II (secondary objective) are as follows Age ≥ 18 years Hematologic malignancy diagnosis including any subset of lymphoma, leukemia, or myelodysplastic syndrome Received an autologous or allogeneic stem cell transplant at the Hospital of the University of Pennsylvania and experienced a sentinel event of either 1) disease relapse,2) severe (Grade III or IV) graft-versus-host disease, or 3) unplanned hospital admission with length of stay greater than 72 hours The for Phase I Inability to read and write English Not serving as the primary decision maker for their health-related decisions Having a non-hematologic malignancy reason for undergoing transplantation (e.g. aplastic anemia) The for Phase II Not completing participation in Phase I of the study Myeloma diagnosis
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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): 25.0-65.0, Osteoarthritis Osteoarthritis diagnosed by MRI Pregnancy or lactating Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV) Active neurologic disorder End organ damage Uncontrolled endocrine disorder
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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): 20.0-75.0, Osteoarthritis Males and females between 20 and 75 years of age Symptomatic radio-carpal osteoarthritis diagnosed by arthroscanner resistant to medical treatment and candidate to surgery BMI ≥ 20 Kg/m² Written informed consent, signed by patient or legal representative (if patient unable to sign) HB > 10g/dl Negative pregnancy test and efficiency contraception Thrombocytopenia < 150 G/L, Thrombocytosis > 450 G/L, Thrombopathy TP < 70%, TCA patient / witness rapport > 1,20 Anemia: HB < 10g/dl Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA Treatment by platelet inhibiting agent, aspirin, antivitamin K completed more than 2 weeks before Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before Intra articular injection of corticosteroid or hyaluronic acid completed more than 8 weeks before NSAI treatment completed more than 2 weeks before Fever or recent disease completed more than 1 month before Auto immune disease, Inflammatory or microcrystalline Arthritis, Immune deficit
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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, Relapsed/Refractory Multiple Myeloma All patients who have been confirmed as administration of the drug None
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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 MM patients who have received at least 1 prior line of therapy and are considered as RRMM according to IMWG criteria Adult patients (≥ 18 years old) Written informed consent provided Patients who have been enrolled onto other study therapy protocols are also eligible Having a full baseline PRO evaluation completed All data a available to calculate the frailty score Having any kind of psychiatric disorder or major cognitive dysfunction hampering the provision of informed consent Having reported any grade ≥3 adverse event within two weeks prior to study entry Having received more than 5 lines of therapies
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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 Documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytomas, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol Newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age >= 65 years, or in participants less than (<) 65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Meet the clinical laboratory as specified in the protocol A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization Primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma Waldenstrom's disease, or other conditions in which Immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 milligram per day (mg/day) for 4 days) of corticosteroids before treatment Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology for adverse events (NCI-CTCAE), Version 4.03 History of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years) Radiation therapy within 14 days of randomization Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. Participants with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
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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, Crohn Disease Diagnosis of Crohn's disease by standard Active disease based on clinical symptoms, defined as CDAI >250. In patients with an ostomy, the number of liquid stools score in the CDAI will be replaced by the number of times that the ostomy bag is emptied daily Active disease based on endoscopic evaluation, defined as SES-CD score > 3 in at least one bowel segment Failure to respond to (or intolerant/adverse reaction to or declines) a member of each of the class of drugs listed below: 1. corticosteroids 2. azathioprine, 3. 6-mercaptopurine, methotrexate 4. Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab) 5. Anti-integrin agents (natalizumab, vedolizumab) 6. Ustekinumab Failure to respond refers to ongoing objective inflammation with symptoms and, as is traditional, is defined by the gastroenterologist evaluating the patient No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal History of significant toxicity to any medications used in trial (cyclophosphamide, thymoglobulin, vedolizumab) Pregnant or breastfeeding Age <18 Karnofsky Performance Score <60 Patients who have an uncontrolled infection (presumed or documented) despite appropriate therapy for at least one month Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure HIV infected Ejection fraction <30% or requiring supplemental continuous oxygen DLCO <35% or requiring supplementary oxygen Patients for whom an insufficient number of stem cells (<2 X 10^6/kg) have been collected
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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, Acute Kidney Injury Adult patients with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied. Patients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient Patients on dialysis (hemodialysis or peritoneal dialysis)
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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 Male or female patients 18 years or older Biopsy-proven diagnosis of AL amyloidosis according to the following standard Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence If clinical and laboratory parameters insufficient to establish AL amyloidosis or in cases of doubt, amyloid typing may be necessary Measurable disease defined by serum differential free light chain concentration (difference between amyloid forming [involved] and non amyloid forming [uninvolved] free light chain [FLC]) ≥ 50 mg/L) Amyloid organ involvement including renal, cardiac, GI and/or nervous system involvement as well as soft tissue disease Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 Patients must meet the following clinical laboratory Absolute neutrophil count (ANC) ≥1,000/mm3 and platelet count ≥75,000/mm3 Hemoglobin ≥ 8.0 g/dL Female patients who are lactating or have a positive serum pregnancy test during the screening period Major surgery within 14 days before enrollment Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment Evidence of current uncontrolled cardiovascular conditions uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, *unstable angina, or myocardial infarction within the past 6 months. Recent history of myocardial infarction in the six months prior to registration Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
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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, Kidney Injury Adult patients that will undergo VAD placement Patients able to give consent Patients on dialysis (hemodialysis or peritoneal dialysis) Non-elective VAD placement (VAD implantation decision made within 24 hours)
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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, Contrast-induced Nephropathy Participants, older than 18 years old and received contrast enhanced CT scan in the emergency medicine department The Mehran Risk Score is greater than 5 points The Mehran Risk Score is under 6 points Participants who doesn't want to enroll the 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, Immature Arteriovenous Fistula Patients with End stage renal disease (ESRD) Patients on hemodialysis Patients using central venous catheter (CVC) Patients who had a new AVF created after commencing dialysis Patients who had immature fistula ( 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min) • Children with Age below 18
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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, ISS Stage I Plasma Cell Myeloma ISS Stage II Plasma Cell Myeloma ISS Stage III Plasma Cell Myeloma Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma International Staging System (ISS) stage I-III multiple myeloma that has progressive, relapsed, or refractory disease Able to give informed consent Eastern Cooperative Oncology Group (ECOG) 0-1 Relapsed and/or refractory myeloma; there is no minimum or maximum number of previous therapies that a patient may have received previously before being put on the current trial ≥ 1 osseous and/or extra-osseous lesion that can be radiated Candidate for pembrolizumab (as determined by physician, and adequate organ function) Candidate for radiotherapy (as determined by treatment physician); these patients can have symptomatic disease and/or asymptomatic disease; a minimum of one site of radiation is required to any osseous and/or any extra-osseous disease; radiation to any bony parts of the head and neck, skull, spine, ribs, and/or extremities are allowed; radiation to any bony part for documented lytic disease is allowed; radiation to any soft tissue plasmacytoma (including osseous and extra-osseous plasmacytoma) is allowed; the only for radiation, is central nervous system (CNS) metastases Measurable myeloma disease (urine protein > 200 mg in 24 hours [hr] urine collection, serum free light chain ratio > 100 with an abnormal k/l ratio, serum M protein > 0.5 g/dl); 12 of the 24 patients do not have to have measurable disease Negative urine pregnancy test within 2 weeks for female subjects; female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy Abstinence is acceptable, if this is the usual life style and preferred contraception for the patient Previous anti-programmed cell death protein 1 (PD1) or anti-PD-L1 Solitary plasmacytoma Smoldering (asymptomatic) multiple myeloma Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, End-stage Renal Disease Hemodialysis End-stage renal disease patients treated with thrice-a-week OL-HDF for at least 6 months Residual urine < 100 mL/day Active cardiovascular disease Active malignancy Pregnancy 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Life expectancy of at least 12 weeks Documented multiple myeloma Received 3 to 5 prior lines of therapy for multiple myeloma, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) Achieved a response (minimal response [MR] or better) to at least one prior regimen Documented evidence of progressive disease (as defined by the IMWG criteria) on or after their last prior therapy, or participants who were intolerant to their last prior therapy Toxicities resulting from previous therapy (including peripheral neuropathy) that must be resolved or stabilized to Grade 1 Anti-myeloma treatment within 14 days or 5 pharmacokinetic (PK) half-lives of the treatment, whichever is longer, before the date of randomization Completion of autologous stem cell transplant within 100 days prior to the date of randomization Prior allogeneic stem cell transplant as well as prior solid organ transplant Spinal cord compression not definitively treated with surgery and/or radiation Prior treatment with MEK inhibitors, B-cell lymphoma-2 (Bcl-2) inhibitors, or immune checkpoint inhibitor therapies including anti-cytotoxic T-lymphocyte associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) Treatment with systemic immunostimulatory agents within 28 days or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment Treatment with systemic immunosuppressive medication within 14 days prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study Prior radiation therapy within 14 days prior to study enrollment and/or persistence of radiation-related adverse effects History or evidence of retinal pathology on ophthalmic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration Left ventricular ejection fraction (LVEF) below institutional lower limit of normal
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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): 60.0-75.0, Multiple Myeloma AL Amyloidosis Patients with histologically-confirmed symptomatic multiple myeloma or AL amyloidosis undergoing autologous HCT with melphalan 140 or 200 mg/m2 Age 60 through 75 years Have at least 3 million x 10e6 CD34+ cells/kg to be infused Diffusion capacity >45% (adjusted for hemoglobin) as predicted by pulmonary function testing KPS performance status ≥ 60% or ECOG Performance Status score of 0-2 Clinical laboratory values meeting the following within 4 weeks before enrollment LVEF >45% by MUGA or rest ECHO Diffusion capacity >45% (adjusted for hemoglobin) as predicted pulmonary function testing Platelet count ≥ 20 x 10^9/L ALT and AST ≤ 2.5 x ULN Prior exposure to agents targeting IL-6 or the IL-6 receptor Other malignancy within the past 2 years, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix Concurrent medical condition or disease (eg, autoimmune disease, active systemic Infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in the study Vaccination with live attenuated vaccines within 4 weeks of first study agent administration Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B (Hep B) surface antigen positivity. Patients with Hep B Core positivity can be enrolled if the Hep B PCR is negative, and they are on antiviral suppression Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half lives before enrollment or is currently enrolled in the treatment stage of an investigational study Had hospitalization for infection or major surgery (eg, requiring general anesthesia) within 2 weeks before enrollment or have not fully recovered from surgery. Note: subjects with surgical procedures conducted under local anesthesia may participate A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study agent
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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, Leukemia Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell) Bone marrow involvement with ≥20% lymphoblasts Age ≥ 60 Years OR Patients with relapsed or refractory acute lumphoblastic leukemia (B-cell or T-cell) defined as receiving one or more cytotoxic containing regimens Bone marrow involvement with ≥5% lymphoblasts Age ≥ 18 Years Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Refer to Appendix D) Adequate organ function Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless clearly due to disease involvement Ph-positive ALL, Burkitt's leukemia/lymphoma, or lymphoblastic lymphoma Patient is pregnant or breastfeeding Patients with uncontrolled infection Hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV) Major surgery or radiation therapy within 4 weeks prior to the first study dose Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and/or dexamethasone, or one dose of cytarabine) prior to starting therapy Symptomatic or untreated leptomeningeal disease or spinal cord compression Patients with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months) Patients with a cardiac ejection fraction (as measured by either Multi Gated Acquisition (MUGA) or echocardiogram (EKG)) <40% History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)
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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, Hematopoietic Cell Transplantation Recipient Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Patient must have relapsed or refractory myeloma that fits or did fit IMWG diagnostic for multiple myeloma; patients with AL amyloidosis and polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) are excluded; measurable disease is not required Patient undergoing autologous transplant as part of first line therapy All races and ethnic groups are eligible for this study Patients must also have an adequate autologous graft as defined as a cryopreserved peripheral blood stem cell (PBSC) graft containing > 2 x 10^6 CD34+ cells/kg patient weight Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%) is required for eligibility; those patients with lower performance status based solely on bone pain secondary to multiple myeloma are eligible Absolute neutrophil count (ANC) > 1000/uL Platelet count > 50,000 Transfusion independent Total bilirubin < 1.5 mg/dL Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x the institutional upper limit of normal Patients who are receiving any other anti-myeloma investigational agents Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
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0
|
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Plasma Cell Myeloma Secondary Amyloidosis All subjects must have the ability to understand and the willingness to sign a written informed consent Histologically confirmed diagnosis of multiple myeloma; (patients with multiple myeloma with secondary amyloidosis are eligible) Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-13 months of the first dose of initial therapy Eastern Cooperative Oncology Group (ECOG) =< 2 Patients with planned standard of care ASCT using melphalan 200 mg/m^2; dose modifications in accordance with creatinine clearance levels are allowed per physician judgment Adequate organ function for high dose chemotherapy and autologous stem cell transplant (as per institution standard operating procedure [SOP]) Adequate cell dose > 2.5 x 10^6 CD34+ cells/kg Absolute neutrophil count (ANC) >= 1000/mm^3 Platelet count >= 75,000/mm^3; platelet transfusions to help patients meet are not allowed within 7 days before study enrollment Total bilirubin =< 1.5 x the upper limit of normal (ULN) Prior disease progression with daratumumab or other anti-CD38 antibody History of organ or previous autologous/allogeneic stem cell transplantation Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance Female patients who are lactating or have a positive pregnancy test during the screening period Evidence of multiple myeloma (MM) disease progression any time prior to enrollment; progression from smoldering to active myeloma is not exclusionary History of plasma cell leukemia or central nervous system (CNS) involvement Major surgery within 14 days prior to start of study treatment Infection requiring systemic antibiotic therapy within 14 days prior to the start of study treatment Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
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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, Chronic Hepatitis c years of age or older HCV patients treated with direct-acting antiviral treatment Patients with a prior treatment blood sample Patients with sustained virological response or virological relapse HIV or hepatitis B virus (HBV) coinfection
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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): 14.0-65.0, Autologous Hematopoietic Stem Cell Transplantation Conditioning Multiple Myeloma Multiple Myeloma patients Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Plasma Cell Leukemia Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Diagnosis of multiple myeloma with documented relapsed or refractory disease according to International Myeloma Working Group (IMWG) or relapsed/refractory plasma cell leukemia Collection of a bone marrow, fluid or tissue sample that is expected to have enough cells to run the assay Measurable disease defined by one of the following Serum monoclonal protein >= 0.5 g/dL by serum protein electrophoresis (SPEP) >= 200 mg/monoclonal protein in urine on 24 hr urine protein electrophoresis (UPEP) Involved serum free light chain (FLC) >= 10 mg/dL and abnormal involved:uninvolved ratio Plasma cytomas that are palpable per exam or measurable per standard radiologic review Circulating plasma cells >= 2,000 if diagnosis of plasma cell leukemia Minimum of 3 prior lines of therapy including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 Mucosal or internal bleeding, or platelet transfusion refractory Any medical conditions that would impose excessive risk to the patient, or would adversely affect his/her participation in the study Known active infection requiring antibiotics within 7 days of initiation of study treatment, unless considered controlled in the opinion of the investigator Other malignancy with life expectancy < 1 year due to the other malignancy Pregnant or breast feeding women Serious psychiatric illness, alcoholism, or drug addiction Human immunodeficiency virus (HIV), or active hepatitis B or C infection Previous treatments for multiple myeloma (MM) within 2 weeks of initiation of study treatment Prior autologous or allogeneic stem cell transplantation (SCT) within 12 weeks of initiation of study treatment Prior allogeneic hematopoietic cell transplantation (HCT) with active graft versus host disease (GVHD) on therapeutic dosing of immunosuppression or prednisone > 20 mg daily equivalent
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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): 5.0-999.0, Oral Mucositis Leukemia The following are the 1. Children/Adults with leukemia (ALL, AML) receiving intensive (high dose) chemotherapy treatment such as myeloablative, doxorubicin or methotrexate during induction, consolidation and re-induction therapy. 2. Absence of any home remedy for mucositis 3. Patients with grades 1-3 OM based on the WHO grading system Patients under non intensive chemotherapeutic treatment. 2. Presence of advanced or severe periodontitis (patients with periodontal pockets of 6mm or more). 3. Patients with a cognitive disability which my no enable them to assess their pain 4. History of allergy to honey or olive oil
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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, Leucotrichia Age > 18 Vitiligo patients with/ without leukotrichia within the vitiliginous areas Age < 18 Premature hair graying in the trunk before the age of 30
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0
|
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Psoriasis Vulgaris Patients planned to receive topical treatment of any kind to prevent relapse of symptoms Written informed consent Contraindications to selected treatment Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy
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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 Patients with non-relapsed multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay OR Patients with non-secretory multiple myeloma (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis [serum protein electrophoresis (SPEP)] and immunofixation (serum immunofixation electrophoresis [SIFE]) and the absence of Bence Jones protein in the urine [urine protein electrophoresis (UPEP)] defined by use of conventional electrophoresis and immunofixation [urine immunofixation electrophoresis (UIFE) techniques]) but with measurable disease on imaging studies like magnetic resonance imaging (MRI), computed tomography (CT) scan or positron emission tomography (PET) scan Patients who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy Karnofsky performance score 70% or higher Left ventricular ejection fraction at rest > 40% within 3 months of registration Bilirubin < 2 x the upper limit of normal (except patients with Gilbert syndrome in whom bilirubin level of > 2 x upper normal limit will be allowed) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x the upper limit of normal Creatinine clearance of >= 40 mL/min, estimated or calculated using the Cockcroft-Gault equation Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) > 50% of predicted value (corrected for hemoglobin) within 3 months of registration All female and male subjects of reproductive potential must consent to the use of effective contraceptive methods as advised by the study doctor during treatment Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms) Patients seropositive for the human immunodeficiency virus (HIV) Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities Patients participating in an investigational new drug protocol within 14 days before enrollment Female patients who are pregnant (positive beta-human chorionic gonadotropin [b-HCG]) or breast feeding Prior hematopoietic cell transplantation allogeneic or autologous (A prior autologous HCT will be allowed as long as it was part of tandem transplantation) Prior organ transplant requiring immunosuppressive therapy
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Multiple Myeloma Key 1. Diagnosis of multiple myeloma (MM) with relapsed and/or refractory (R/R) disease. Participants must have received at least 3 prior anti-myeloma treatment regimens. Participants must have previously received all of the following therapies and must be refractory to the last line of therapy prior to entering the study (not applicable to Phase 2a): 1. Autologous stem cell transplant 2. A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or in combination 3. Anti-CD38 (eg, daratumumab) as part of a combination regimen or as a monotherapy Subjects who have received prior allogeneic stem cell transplant or donor lymphocyte infusion at least 100 days before enrollment with no signs of acute or chronic graft-versus-host disease (GVHD) will be considered eligible. Subjects who were not candidates to receive one or more of the above treatments (ie, contraindicated) are eligible. 2. Subjects must have measurable disease. 3. Subject must be willing to provide fresh bone marrow biopsy samples during Screening (and prior to study treatment, if required). 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function 6. Phase 2a cohorts only Subjects with R/R MM who have been previously treated with prior BCMA-directed anti-myeloma therapy, achieved at least a partial response (PR) and progressed on the following treatment: 1. Subjects who have received prior BCMA-directed CAR T-cell therapy. The last CAR T-cell therapy must have been received at least 6 months prior to JCARH125 screening. 2. Subjects who have received prior BCMA-directed T-cell engager therapy. 3. Subjects who have received prior BCMA-directed antibody-drug conjugate therapy Subjects with known active or history of CNS involvement by malignancy 2. Subjects with solitary plasmacytoma; active or history of plasma cell leukemia (PCL); Waldenstrom's macroglobulinemia; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasmaproliferative disorder, Skin changes (POEMS) syndrome; or symptomatic amyloidosis 3. Subjects who are considered eligible to receive and have not refused an autologous stem cell transplant 4. History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected. 5. Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R]) 6. Prior CAR T-cell or other genetically-modified T-cell therapy (not applicable for subjects enrolled in Phase 2a cohorts) 7. Prior treatment with a BCMA-targeted agent (not applicable for subjects enrolled in Phase 2a cohorts) 8. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 9. Untreated or active infection at time of initial screening, at the time of leukapheresis, within 72 hrs before lymphodepletion, or 5 days before JCARH125 infusion. 10. History of any of the following cardiovascular conditions within 6 months of screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease 11. Subjects with known hypersensitivity to E Coli-derived proteins (only applicable to subjects in Phase 1 Anakinra Cohort) 12. History of severe immediate hypersensitivity reaction to any of the protocol-mandated or recommended agents used 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): 65.0-999.0, Multiple Myeloma Patient > 65 years Resident of the departments in Île-de-France region (75, 92, 93 and 94) Symptomatic multiple myeloma (relapsed or no) Patient planned to receive one of the following chemotherapy protocols including bortezomib (VELCADE®): VMP (Velcade, Melphalan, Prednisone), VCD (Velcade, Cyclophosphamide, Dexamethasone), VelDex (Velcade, Dexamethasone), VRD (Velcade, Revlimid, Dexamethasone) Ineligible for autologous hematopoietic stem-cell transplantation (ASCT) Covered by a health insurance Patient who does not oppose to the use of his/her medical data for the purpose of clinical research Adult patients under guardianship will can be enrolled in the study, a consent of tutor is needed completed by patient's consent Resident of the departments of 77, 78 and 91 in Île-de-France region Asymptomatic myeloma Life expectancy < 6 months Patient does not understand French language
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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): 14.0-999.0, Lymphoma, Large B-Cell, Diffuse Stage III Follicular Lymphoma Male or female patient age >14 years old; 2. Pathological types diffuse large B lymphoma, and stage III follicular lymphoma; 3. At the initial stage of therapy, received standard R-CHOP regimen and complete remission after the first course of treatment; 4. After complete remission, not consider to receive hematopoietic stem cell transplantation or chimeric antigen receptor T cell immunotherapy; 5. Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) not exceed 2 times of the normal upper limit; 6. Serum total bilirubin and creatinine not exceed 1.5 times of the normal upper limit; 7. Serum creatinine not exceed 1.5mg/dl; 8. Patients with high risk factors, including age > 60 year, or with diabetes/ impaired glucose tolerance, or with International Prognostic Index (IPI) score ≥2. 9. Sign informed consent file Past medical history of high doses of cytarabine, methotrexate and rituximab maintenance therapy; 2. Past medical history of any type of hematopoietic stem cell transplantation; 3. Past medical history of lactic acidosis; 4. Extreme weight loss failure, malnutrition or dehydration patients; 5. Pregnant women or lactating women, or women who do not take contraceptive measures for childbearing age; 6. Alopecia, mental retardation or psychiatric disorders that affect the patient's normal informed consent; 7. Type 1.2 diabetes with ketoacidosis, liver function or renal insufficiency, pulmonary insufficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension or hypoxia; 8. Diabetes complicated with severe chronic complications (such as diabetic nephropathy, diabetic retinopathy); 9. Any other serious complications occurred, depending on the outcome of the study; 10. Before the intravenous pyelography or anterior angiography; 11. Alcoholics; 12. Deficiency of Vitamin B12, folic acid or iron
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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, H Pylori Infection All patients complained of symptoms suggestive of gastritis whether acute (within two weeks) or chronic (three or more months) and were diagnosed at endoscopy to have H.pylori infection by biopsy Patients aged more than 18 years old Both sexes (male & female) Patients with malignant diseases or Gastric malignancy Other causes of Thrombocytopenia as systemic lupus erythematous and human immunodeficiency virus and or acquired immunodeficiency syndrome Other causes of Anemias with or without blood loss
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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, Kidney Failure, Chronic an adult receiving dialysis for at least 6 months at least one active prescription for a potentially inappropriate medication (e.g., opioid) advanced dementia hospice care 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): 20.0-999.0, Chronic Kidney Disease Hypertension Subjects are 20 years old and above, Chinese speaking, and able and willing to provide informed consent Subjects own mobile devices such as cell phones and tablets Subjects were diagnosed with Chronic Kidney Diseases and were taking a single antihypertensive agent for more than three months or they are not receiving treatment but with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg starting dialysis or having a kidney transplant (RRT) participating in other interventional study cognitively impaired unable to give consent life expectancy 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): 18.0-999.0, Multiple Myeloma Patients with age≥ 18 years old who are willing to receive the treatment of osalmid; 2. Patients must be diagnosed with active and measurable (symptomatic) multiple myeloma according to IMWG 2003/WHO 2008(V4) MM diagnosis detailed as following:1). Positive M protein in serum and/or urine; 2). Pathologically diagnosed with multiple myeloma or found colonic plasma cells in bone marrow; 3). At least one symptom of related organ damage or tissue lesion: a. hypercalcemia: serum calcium increases 0.25mmol/L or more over upper limit of normal value(ULN) or > 2.75mmol/L; b. anemia: Hemoglobin decreases 20g/L or more over lower limit of normal value(LLN) or <100g/L；c. bone lesion: lytic bone lesion or osteoporosis accompanied with compressive fracture (confirmed with MRI、CT or PET-CT); d. others: symptomatic hyperviscosity, amyloidosis, recurrent infection (more than twice within 12 months); 3. Eastern Cancer Organization Group (ECOG) score≤2 and expected survival>2 months; 4. Belongs to "measurable disease": serum M protein ≥10g/L and/or 24 hour urine M protein ≥200mg; 5. No active infectious diseases; 6. No severe organic dysfunction (except renal function insufficiency caused by multiple myeloma), lab results must meet the following (within 7 days before initiation of therapy): a. Total bilirubin ≤ 1.5*ULN (same age group); b. AST and ALT ≤ 2.5*ULN (same age group); c. Cardiac enzyme < 2*ULN (same age group); d. Normal ejection fraction confirmed in echo; 7. Able to swallow oral medicine; 8. Volunteer to participate into this clinical trial and the informed consents must be written by patients themselves or their direct relatives. Authorized medical attorney or direct relatives can write the informed consents if it is not good for patients' treatment when consider the severity of their disease Received anti-myeloma treatment before (not radiotherapy, bisphosphonates or single short term steroids treatment [the dose and duration of prednisone should be no more than 40mg/d and 4 days and should discontinue this treatment within 14 days before the enrollment]); 2. Primary or secondary plasma cell leukemia; 3. Positive HIV tests or active infection phase of HAV, HBV and HCV; or HBV DNA copies >104/ml；AST and ALT > 2.5*ULN (same age group); 4. Severe diseases that threaten patients with unacceptable risks; these diseases but are not confined to unstable heart diseases, which can be defined as cardiac accidents such as MI within 6 months, NYHA stage Ⅲ-Ⅳ heart failure, uncontrolled atrial fibrillation or hypertension and myeloma requiring long term administration of steroids or immune-inhibitors; 5. Renal failure requiring hemodialysis or peritoneal dialysis; 6. Severe embolic or thrombotic events before therapy; 7. Major surgery within 30 days before being enrolled; 8. Total obstruction of biliary tract; 9. Glaucoma; 10. History of malignancies except multiple myeloma unless being cured for more than 3 years; 11. Severe allergic to osalmide capsule; 12. Gestation, lactation or disagreed pregnancy; 13. Severe infectious diseases (uncured tuberculosis, pulmonary aspergillosis); 14. Seizures requiring medicines, patients with dementias and other mental disorders who cannot understand or obey the protocol; 15. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's compliance in the study or assessment of the results of the study; 16. Severe liver and kidney dysfunction; 17. Patients who are considered unsuitable for enrollment by investigators
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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 Immune System Diseases Written informed consent and HIPAA authorization for release of personal health information. Patients must sign a consent to undergo cell procurement. Written informed consent to enroll in the CAR T-cell therapy trial must be obtained prior to lymphodepletion Age ≥ 18 years at the time of consent Karnofsky score of ≥ 60% Diagnosis of relapsed or refractory multiple myeloma (as defined by the Revised Uniform Response outlined by the IMWG Measurable disease as defined by one or more of the following: 1) serum M-protein ≥1.0 g/dL (≥0.5 g/dL for immunoglobulin A myeloma); 2) urine M-protein ≥200 mg/24 hours; 3) involved serum free light chain level ≥10 mg/dL AND an abnormal serum free light chain ratio. Patients with non-secretory disease and a baseline marrow burden of myeloma of at least 30% will also be eligible to participate Two lines of therapy will be allowed if the patient has disease that is refractory to both an immunomodulatory agent (lenalidomide or pomalidomide) and a proteasome inhibitor Received high dose melphalan followed by autologous stem-cell transplant or is not eligible for or has declined the procedure Allogeneic stem cell transplantation is allowed provided the patient is ≥ 1 year from transplant, not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft-versus-host disease, and has no evidence of active graft-versus-host disease or infection Demonstrate adequate organ function prior to cell procurement as defined below Creatinine Clearance using the Cockcroft-Gault formula: ≥ 50 mL/min
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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, Systemic Amyloidosis Patients must have a confirmed diagnosis of systemic amyloidosis, based on histologic confirmation that a biopsy contains deposits of apple-green birefringent, Congophilic material. Additionally, the type of amyloidosis (AL, ATTR, ALect2, or other) should be characterized Patients enrolled in Part 1 must have widespread AL amyloidosis, defined as biopsy proven or clinically detectable involvement, of at least two organs (excluding the peripheral nervous system) All patients will be 18 years of age or older, and there are no gender or racial restrictions Women of child bearing potential (those who have not been surgically sterilized, are not postmenopausal [typically understood to mean last menstrual period >2 y ago without pharmaceutical intervention], and women who are fertile) must test negative for pregnancy in a laboratory test administered by the site physician Patients who have had or are currently receiving therapy or other drug-based anti-amyloid regimens can be included on study Patients must provide signed, written, informed consent and be willing to comply with requirements, scheduled visits, and follow-up studies Due to annual dosimetry limitations, patients who have participated in another nuclear medicine amyloid imaging clinical trial protocol can be included in this study no earlier than 12 months after the previous radiotracer injection of patients with amyloid subsets: AL, ATTR, and ALect2 will continue until the trial has achieved recruitment goals for each subset: 20 AL; 10 ATTR; 5 ALect2; and 5 "Other" -1. Individuals with significant cardiac dysfunction (New York Heart Association class IV - "Unable to carry on any physical activity without shortness of breath or angina. Shortness of breath at rest. If any physical activity is undertaken, discomfort increases") or renal insufficiency that requires dialysis Those with significant co-morbidity (e.g., Eastern Cooperative Oncology Group (ECOG) score of 3 or greater), uncontrolled infection, or other serious illness Patients with an Saturation of Peripheral Oxygen (SpO2) of ≤ 92% as noted in the medical record Women who are of child bearing potential (those who have not been surgically sterilized, are not postmenopausal [typically understood to mean last menstrual period >2 y ago without pharmaceutical intervention], and women who are fertile), are pregnant, or are nursing. Women who test positive for pregnancy in a laboratory test administered by the site physician Patients who have received any amyloidophilic radiotracer within the past 12 months Patients with exposure to heparin, or heparin-based medications, within 7 days prior to the imaging study Patients who have a known allergy to acetaminophen, Benadryl, or iOSAT iodine 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): 18.0-999.0, Multiple Myeloma Patients with diagnosed symptomatic MM who have completed one or two prior lines of therapy; single or tandem autologous stem cell transplant is not considered a separate line of therapy and is not mandatory; and have achieved at least PR to last line of therapy, and who experience asymptomatic biochemical progression not meeting for SPR. 2. Males and females ≥18 years of age. 3. Life expectancy of more than 3 months. 4. ECOG performance status of 0-2. 5. Adequate hepatic function, with bilirubin ≤1.5 x ULN and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN. 6. ANC ≥1.0 x 109/L, hemoglobin ≥8 g/dL, platelet count ≥75 x 109/L. 7. Calculated creatinine clearance (by Cockroft-Gault) ≥50 mL/min (this equation is as follows: Creatinine clearance in ml/min: (140 age) x body weight (kg) / 72 x plasma creatinine (mg/dL); multiplied by 0.85 for women) or serum creatinine below 2 g/dL. 8. Negative pregnancy test (serum βHCG) for women of childbearing potential (including pre-menopausal women who have had a tubal ligation) and for all women not meeting the definition of postmenopausal (≥ 24 months of amenorrhea), and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential. 9. FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the study. 10. Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. 11. Voluntary written informed consent Potential subjects with evidence of progressive disease (CRAB symptoms) as per IMWG criteria. 2. Patient with SPR significant paraprotein relapse defined as doubling of the M-component in two consecutive measurements separated by < 2 months; or an increase in the absolute levels of serum M protein by 1g/dl, or urine M protein by 500mg /24h, or involved serum FLC level by 20mg/dl (plus an abnormal FLC ratio) in two consecutive measurements separated by < 2 months. 3. Patients who have already started or received post-transplant maintenance or consolidation treatment. 4. Subject has received daratumumab or other anti-CD38 therapies previously. 5. Patients not able to tolerate daratumumab or required concomitant medication and procedures. 6. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal. 7. Known moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study). 8. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). 9. Plasma cell leukemia. 10. Waldenström's macroglobulinemia. 11. CNS involvement. 12. Pregnant or lactating females. 13. Radiotherapy within 14 days before randomization. Seven days may be considered if to single area. 14. Major surgery within 3 weeks prior to first dose. Kyfoplasty is not considered as a major surgery. 15. Myocardial infarction within 3 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 16. Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening. 17. Patient who in investigator's opinion is unable to comply with the protocol requirements. 18. Uncontrolled hypertension or diabetes. 19. Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to enter the study. 20. Active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. 21. Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone. 22. Any 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. 1. Patients with diagnosed symptomatic MM who have completed one or two prior lines of therapy; single or tandem autologous stem cell transplant is not considered a separate line of therapy and is not mandatory; and have achieved CR with negative MRD to the last line of therapy and who remain in CR MRD negative. The last response assessment confirming CR MRD negative status based on assessment of bone marrow sample using flow cytometry with sensitivity of at least 10-5 needs to be performed not earlier than 3 months before to the study. 2. Males and females ≥18 years of age. 3. Life expectancy of more than 3 months. 4. ECOG performance status of 0-2. 5. Adequate hepatic function, with bilirubin ≤1.5 x ULN and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN. 6. ANC ≥1.0 x 109/L, hemoglobin ≥8 g/dL, platelet count ≥75 x 109/L. 7. Calculated creatinine clearance (by Cockroft-Gault) ≥50 mL/min (this equation is as follows: Creatinine clearance in ml/min: (140 age) x body weight (kg) / 72 x plasma creatinine (mg/dL); multiplied by 0.85 for women) or serum creatinine below 2 g/dL. 8. Negative pregnancy test (serum βHCG) for women of childbearing potential (including pre-menopausal women who have had a tubal ligation) and for all women not meeting the definition of postmenopausal (≥ 24 months of amenorrhea), and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential 9. FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the study. 10. Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. 11. Voluntary written informed consent Potential subjects with evidence of progressive disease (CRAB symptoms) as per IMWG criteria. 2. Patient with SPR significant paraprotein relapse defined as doubling of the M-component in two consecutive measurements separated by < 2 months; or an increase in the absolute levels of serum M protein by 1g/dl, or urine M protein by 500mg /24h, or involved serum FLC level by 20mg/dl (plus an abnormal FLC ratio) in two consecutive measurements separated by < 2 months. 3. Patients who have already started or received post-transplant maintenance or consolidation treatment. 4. Subject has received daratumumab or other anti-CD38 therapies previously. 5. Patients not able to tolerate daratumumab or required concomitant medication and procedures. 6. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal. 7. Known moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study). 8. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). 9. Plasma cell leukemia. 10. Waldenström's macroglobulinemia. 11. CNS involvement. 12. Pregnant or lactating females. 13. Radiotherapy within 14 days before randomization. Seven days may be considered if to single area. 14. Major surgery within 3 weeks prior to first dose. Kyfoplasty is not considered as a major surgery. 15. Myocardial infarction within 3 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 16. Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12 lead ECG during screening. 17. Patient who in investigator's opinion is unable to comply with the protocol requirements. 18. Uncontrolled hypertension or diabetes. 19. Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to enter the study. 20. Active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. 21. Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone. 22. Any 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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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell 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 Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myelo-ma with 1. or 2. relapse after autologous stem cell transplantation 2. Patients age: 18 years at time of (female and male) 3. Performance status ECOG < 2 4. Availability of haploidentical, matched or mismatched relative or unrelated donor 5. Patients understand and voluntarily sign an informed consent 6. The study population includes female of childbearing potential (FOCP). FOCP have to agree to comply with the applicable contraceptive requirements of the protocol as named below for the duration of the study and 6 months after end of study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization). 7. Men who are sexually active with FOCP must be instructed to use male contraception (condom) in order to avoid exposure of an existing embryo/fetus. Contraception should be continued until 6 months after end of study Severe active infection or other uncontrolled severe conditioning 2. Severe renal, hepatic, pulmonary or cardiac disease, such as Total bilirubin, SGPT or SGOT > 3 times upper the normal level Left ventricular ejection fraction < 30 % Creatinine clearance < 30 ml/min DLCO < 35 % and/or receiving supplementary continuous oxygen 3. Positive serology for HIV 4. Pregnant or lactating women (positive serum pregnancy test) 5. Women of child-bearing potential with unclear contraception 6. Age < 18 and > 65 years. 7. Uncontrolled invasive fungal infection at time of screening (baseline) 8. Serious psychiatric or psychological disorders 9. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
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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, Cancer Breast Cancer Lung Cancer Colon Cancer Ovarian Cancer Melanoma Lymphoma Leukemia Mutation Lynch Syndrome Cowden Syndrome BRCA1 Mutation BRCA2 Mutation Uterine Cancer Myeloma Kidney Cancer Head and Neck Cancer Meningioma Patients with either histological confirmation of a solid tumor or hematological malignancy, OR patients identified as high-risk for cancer (based on identified aberration in cancer predisposition gene or on hormonal and/or family history without known aberration). 2. Patient must be ≥ 18 years old. 3. All patients must have signed and dated an informed consent form for this study. 4. If patients are being co-consented for a separate primary research study listed in Appendix I, they must fulfill the for that separate primary research study. If there is a discrepancy in the between protocols, the separate primary research study's take precedence None
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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, Extrathoracic Sarcoidosis Clinical and radiological presentation confirming sarcoidosis Presence of non caseating granuloma in at least one organ Presence of at least one extrathoracic localization, including hypercalcemia of other causes of granuloma Presence of serious organ involvement or relapse/apparition of a new localization despite a first-line immunosuppressive drug Age superior or equal to 18 years Pregnancy or breast feeding or women in age of pregnancy without efficient contraception Patients with multiple sclerosis Patients with prior history of any cancer in the 5 years before (except for cutaneous basocellular cancers) Patients with a history of hypersensitivity to infliximab to other murine proteins, or to any of the excipients Patients with untreated tuberculosis or current other severe infections such as sepsis, abscesses, and opportunistic infections• Patients with moderate or severe heart failure (NYHA class III/IV) Concurrent vaccination with live vaccines during therapy Inability to understand information about the protocol Adult subject under legal protection or unable to consent No informed consent Absence of affiliation to National French social security system
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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, Diffuse Large B Cell Lymphoma New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab and anthracycline-containing regimens No central nervous system involvement on initial staging Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale) Renal function: creatinine clearance >45 ml/min Not pregnant; agreeable to contraception Written informed consent High risk for central nervous system recurrence as determined by one of the following high-risk features: 1. high central nervous system International Prognostic Index, 2. testicular, breast, or uterine involvement, 3. dual expresser or double/triple-hit status, 4. HIV positive status, or 5. Molecularly defined high-risk subtype pregancy unable to provide informed consent significant comorbidity in the investigator's judgement
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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, Relapsed Refractory Multiple Myeloma Willing to be registered into the pomalidomide (POMALYST®) Risk Evaluation and Mitigation Strategy (REMS®) program Enrolled in the MMRF002 Molecular Profiling Protocol (NCT02884102) with report less than 120 days old Disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or prostate cancer not requiring therapy High risk patients with relapsed refractory multiple myeloma (RRMM), who have received at least one prior but no more than 3 prior therapies exposed to both a PI and an IMiD had early relapse after initial treatment Early relapse as defined by at least one of the following: (Relapse is defined as the IMWG uniform response) 1. Relapse within 3 years of initiation of induction chemo therapy for post autologous stem cell transplantation (ASCT) followed by maintenance, or 18 months if unmaintained after ASCT 2. Within 18 months of initial non-ASCT based therapy Patients must have progressed after their most recent treatment and require therapy for myeloma Females of reproductive potential must have a negative pregnancy test at baseline, be non-lactating, and willing to adhere to scheduled pregnancy testing Females of reproductive potential and males must practice and acceptable method of birth control Patients will be ineligible for this study if they meet any one of the following Aggressive multiple myeloma requiring immediate treatment as defined by Lactate dehydrogenase (LDH) > 2 times ULN Presence of symptomatic extramedullary disease or central nervous system involvement Hypercalcemia >11.5 mg/dl Acute worsening of renal function (CrCl < 30 ml/min) directly related to myeloma relapse Any neurological emergency related to myeloma Clinical symptoms of hyperviscosity related to monoclonal protein Involved serum free light chain > 100 mg/dL (1000 mg/L) in the setting of prior diagnosis of cast nephropathy Infection requiring systemic antibiotic therapy or other serious infection within 14 days of enrolment
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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, Plasma Cell Myeloma Patients must meet the following on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator's opinion, willing and able to comply with the protocol requirements Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1 Subject is a transplant-eligible patient that have undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and have achieved ≥ partial response (PR) based on International Myeloma Working Group (IMWG) standard Patients with high risk disease defined as Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG) Plasma cell leukemia at diagnosis with ≥ 20% circulating plasma cells on peripheral blood Subject agrees to refrain from blood donations during therapy on study and for 90 days after therapy is completed Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International units (mIU)/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide through 90 days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 90 days after the last dose of study drug; all patients must be registered in and must comply with all requirements of the pomalidomide Risk Evaluation and Mitigation Strategies (REMS) program; male subjects should refrain from sperm donation for at least 90 days after the last dose of carfilzomib or pomalidomide FCBP refers to sexually mature female, regardless of sexual orientation or whether they have undergone tubal ligation, who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally menopausal for at least 24 consecutive months Diagnosed with smoldering multiple myeloma (MM), monoclonal gammopathy of undetermined significance, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis or standard risk myeloma or secondary plasma cell leukemia High risk patients that did not achieve ≥ PR after stem cell transplant Participant has ≥ grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy Creatinine clearance < 30 mL/min (either actual or calculated value), within 21 days of initiation of protocol therapy; the Cockcroft-Gault formula should be used for calculating creatinine clearance values Platelet count < 75,000 cells/mm³ at time of screening evaluation; transfusion may not be used to meet platelet within 7 days of obtaining screening evaluation Participants with an absolute neutrophil count (ANC) < 1000 cells/mm³ at time of screening evaluation; growth factors may not be used to meet ANC within 14 days of obtaining screening evaluation Participants with hemoglobin level < 8.0 g/dL, at time of screening; transfusion may not be used to meet within 7 days of obtaining screening evaluation Bilirubin > 1.5 x institutional upper limit of normal (ULN), within 21 days of initiation of protocol therapy Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]), or alkaline phosphatase > 3 x institutional ULN, within 21 days of initiation of protocol therapy Other ongoing or prior anti-myeloma therapy; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg p.o. once daily [q.d.] or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment)
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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, Dyspnea; Uremic End Stage Renal Disease Chronic Lung Disease Chronic Heart Disease Hemodialysis-Induced Symptom Sodium Excess Age equal to or greater than 18 years Dialysis vintage equal to or greater than 3 months Smoking history of more than 10 packs/year Active tobacco and/or cannabis smoking Diagnosed chronic pulmonary disease Severe heart failure (NYHA class IV) Active infection (including tuberculosis) or malignancy Pregnancy Inability to give consent or understand written information Peripheral oxygen saturation (by pulse oxymetry) dropping below 80% when performing a 12-seconds breathhold Inability to perform spirometry or plethysmography maneuvers Inability to tolerate MRI due to patient size and/or known history of claustrophobia
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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): 40.0-80.0, Chronic Kidney Disease Stage V The investigators will enroll non-diabetic hypertensive and hyperlipidemic patients undergoing chronic HD Hypertension will be defined as having a systolic blood pressure of >130 mmHg and a diastolic blood pressure >80 mmHg or having any antihypertensive agents Hyperlipidemia will be defined as having LDL cholesterol values more than 100 mg/dl or receiving statins at any dose Eligible patients may be of any age Diabetes mellitus type 1 or 2 Severe heart failure (NYHA class IV) Patients with low compliance or severe psychiatric illnesses Smoking, intake of antioxidant supplements (eg, carotenoids, vitamin C, vitamin E and glutathione), aspirin, or any other drug with established antioxidant properties, hyperlipidemia, obesity (body mass index >30 kg/m2), diabetes, celiac or other intestinal disease, life-threatening Survival expectancy <6 months based on managing physicians assessment Inability to participate in the trial based on managing physicians assessment
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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): 19.0-999.0, Multiple Myeloma Subject is over 19 years old and male or female of any race/ethnicity Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected Subject has voluntarily agreed to participate in the study Subject or subject's legally acceptable representative does not provide written informed consent Female subject is pregnant or nursing. of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of [18F]Florbetaben has to be negative and the women is advised to apply contraceptive measures during her participation in this study Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator Subject has received any investigational drugs or devices within four weeks prior to the study enrollment Subject has been previously included in this study Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible Subject is allergic to Florbetaben or any of ingredients of Florbetaben
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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): 18.0-120.0, Multiple Myeloma Stage I Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Participants who are newly diagnosed considered for high-dose chemotherapy due to: being age <=65 years; without presence of important comorbidity condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Committee review and approval of participants is required before Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 4 months after the last dose of Man, who is sexually active with a woman of child-bearing potential potential must agree to use a latex or synthetic condom, even if he had a successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for four weeks after last dose of thalidomide and Participants with known or suspected COPD or asthma must have a FEV1 test during Screening Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage, and absence of biomarkers activity) Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the medical monitor, is considered cured with minimal risk of recurrence within 5 years) Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids 30 days before treatment Participant has had radiation therapy within 14 days of randomization Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] <50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed) Participants with heart block defined by electrocardiogram or not treated arrhythmia Participant is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have active hepatitis B or hepatitis C or Chagas disease positivity with cardiac involvement Key Patient has malignancy , 3 years of first dose of study treatment (except basal or squamous cell carcinoma or in situ cancer of the cervix) Patients has not recovered from all therapy-related toxicities , grade 2 CTCAE; patients has undergone major surgery < 2 weeks prior to starting drug
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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 Participants must be greater than or equal to 18 years of age Participants must have been diagnosed with multiple myeloma in a first or subsequent remission and have undergone a successful pre-transplant work up and are otherwise eligible for an autotransplant with a busulfan/melphalan preparative regimen at Loyola University Medical Center Participants may receive this preparative regimen if in first or subsequent remission. Participants may enter if they have received a prior autologous stem cell transplant and this therapy produced a remission that lasted greater than 18 months before progression of disease. Participants who have undergone prior allogeneic transplantation are excluded All participants must have responsive disease as defined by a Partial Response or greater to most recent conventional regimen Participants receiving prior carfilzomib will be eligible for provided they demonstrated responsive disease to this agent and either had a remission that lasted greater than 6 months after its discontinuance, or if in remission after a carfilzomib containing regimen administered to qualify for transplant Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) less than or equal to 2 Acceptable heart function test Participants must not have below normal kidney function Participants must not have below normal liver function Participants must not have active bacterial, fungal, or viral infection Participants must not have severe lung function Participants must not have Grade 2 or greater peripheral neuropathy Participants must not have uncontrolled hypertension
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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 Smoldering Multiple Myeloma Participants that are diagnosed with MM, high or intermediate-risk SMM in the iStopMM study will be invited to participate in this study. Each patient must meet all the following to be enrolled in the study: 1. Age more than 18 years. 2. Active MM or 3. Smoldering myeloma, which is untreated, as defined by: Measurable M spike OR pathological FLC ratio AND bone marrow PC% > 10% 4. The following laboratory values obtained ≤ 30 days prior to registration Calculated creatinine clearance ≥ 30mL/min (using CKD-EPI equation) Absolute neutrophil count (ANC) > 1000/mm3 Platelet count > 75000/mm3 Hemoglobin ≥ 8.0 g/dL Total bilirubin ≤ 1.5 x ULN ALT and AST ≤ 3 x ULN 5. Measurable disease as defined by at least one of the following Serum monoclonal protein > 1.0g/L > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis MGUS or low-risk smoldering myeloma. 2. Diagnosed or treated for another malignancy ≤ 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. NOTE: Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 3. If any of the following exist at screening, subject will not be eligible for trial because this trial involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception (per protocol) 4. Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease 5. Other concurrent chemotherapy, or any ancillary therapy considered investigational. NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment. 6. Peripheral neuropathy > Grade 3 on clinical examination or grade 2 with pain within 30 days prior to C1D1. 7. Major surgery ≤14 days prior to C1D1. 8. Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. Note: Prior to trial entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant. 9. Known human immunodeficiency virus (HIV) positive. 10. Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. 11. Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 12. Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products. Known allergies, hypersensitivity, or intolerance to trial drugs. 13. Inability to comply with protocol/procedures. 14. LVEF < 40% for patients treated with carfilzomib
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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, Arteriovenous Fistula Hemodialysis participants should be 18 years or older have an AVF duration on HD greater than 6 months have no memory problems be medically stable patients with double vascular access (central venous catheter and AVF) or grafts as vascular access hospitalized patients at the time of data collection
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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, Relapsed and/or Refractory Multiple Myeloma Key 1. Subject has provided informed consent prior to initiation of any study specific activities/procedures 2. Multiple myeloma meeting the following 3. Pathologically-documented diagnosis of multiple myeloma that is relapsed or is refractory as defined by the following: Relapsed after 3 or more lines of prior therapy that must a proteasome inhibitors (PI), an immunomodulators (IMiD), and a CD38-directed monoclonal antibody in any order during the course of treatment OR refractory to a PI, IMiD, and CD38-directed monoclonal antibody. -Measurable disease, defined by 1 or more of the following at time of screening: 1) serum M-protein > 0.5 g/dL measured by serum protein electrophoresis (SPEP); 2) urinary M-protein excretion > 200 mg/24 hours; 3) Involved serum free light chain (sFLC ) measurement > 10 mg/dL, provided that the sFLC ratio is abnormal (<0.26 or >1.65) as per IMWG response 4. . ECOG performance status of less than or equal to 2 5. Life expectancy of at least 3 months per PI judgement at screening 6. Hematological function without transfusion support (within 7 days from screening assessment) as follows ANC ≥ 1.0 x 10^9/L (without growth factor support) platelet count ≥ 25 x 10^9/L (without transfusions) hemoglobin ≥ 7.0 g/dL (transfusions permitted no later than 48 hours before screening) 7. Renal function as follows: calculated or measured creatinine clearance ≥30 mL/min using the Cockcroft-Gault equation or via 24-hour urine collection with plasma and urine creatinine concentrations, respectively 8. Hepatic function as follows: AST and ALT < 3x upper limit of normal (ULN); TBIL <1.5 x ULN (unless considered due to Gilbert's syndrome) Key Known central nervous system involvement by multiple myeloma 2. Evidence of primary or secondary plasma cell leukemia at the time of screening 3. Waldenstrom's macroglobulinemia 4. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE version 5.0 grade 1 or to levels dictated in the with the exception of grade 2 peripheral neuropathy, alopecia, or toxicities from prior anticancer therapy that are considered irreversible (defined as having been present and stable for > 4 weeks) which may be allowed if they are not otherwise described in the and there is agreement to allow by the PI and Amgen medical monitor 5. History of other malignancy within the past 3 years, with the following exceptions: 1. malignancy treated with curative intent and with no known active disease present for ≥ 1 year before enrollment and felt to be at low risk for recurrence by the treating physician; 2. adequately-treated non-melanoma skin cancer or lentigo maligna without evidence of disease; 3. adequately-treated cervical carcinoma in situ without evidence of disease; 4. breast ductal carcinoma in situ with full surgical resection (ie, negative margins) and without evidence of disease; 5. prostate cancer with a Gleason score < 6 with undetectable PSA over 12 months; 6. treated medullary or papillary thyroid cancer; 7. adequately-treated urothelial papillary noninvasive carcinoma or carcinoma in situ; similar neoplastic conditions with an expectation of > 95% five-year disease-free survival; 8. see criterion # 2 for of subjects with evidence of primary or secondary plasma cell leukemia at the time of screening 6. Known history of amyloidosis 7. Current or known history of autoimmune diseases requiring systemic treatment in past 5 years except vitiligo, resolved childhood asthma/atopy, or subjects with history of hypothyroidism after completing treatment for autoimmune thyroid disease, stable on hormone replacement therapy. 8. Clinically not-controlled chronic or ongoing infectious disease requiring treatment at the time of study day 1 or within the 14 days before study day 1 9. Symptomatic peripheral sensory or motor neuropathy of grade ≥3 10. History or presence of clinically relevant central nervous system (CNS) pathology as uncontrolled epilepsy or seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis 11. Active hepatitis B and C based on the following results: a) Positive for HepBsAg; b) Negative HepBsAg and positive for hepatitis B core antibody; c) Positive Hepatitis C virus antibody (HepCAb) 12. Known or suspected HIV infection or subjects who are HIV seropositive 13. Baseline ECG QTc > 470 msec (applying Fridericia correction) 14. Previously received an allogeneic stem cell transplant and the occurrence of 1 or more of the following: a) received the transplant within 6 months prior to study day 1; b) received immunosuppressive therapy within the last 3 months prior to study day 1; c) any active acute graft versus host disease (GvHD), grade 2 to 4, according to the Glucksberg or active chronic GvHD requiring systemic treatment; d) any systemic therapy against GvHD within 2 weeks prior to start of investigational product treatment 15. Autologous stem cell transplantation < 90 days prior to study day 1 16. Treatment with systemic immune modulators including, but not limited to, nontopical systemic corticosteroids (unless the dose is ≤ 10 mg/day prednisone or equivalent), cyclosporine, and tacrolimus within 2 weeks before study day 1 17. Last anticancer treatment < 2 weeks prior to study day 1 18. Last treatment with a therapeutic antibody less than 4 weeks prior to study day 1 19. Systemic radiation therapy within 28 days prior to study day 1. Focal radiotherapy within 14 days prior to study day 1. 20. Major surgery defined as surgery requiring general anesthesia with endotracheal intubation within 28 days prior to study day 1, unless discussed with and approved by Amgen medical monitor 21. Prior treatment with any drug that specifically targets BCMA on tumor cells (eg, other bi-specific antibody constructs, antibody drug conjugates, or CAR T-cells, except for subjects who were previously treated with AMG 420 in this study and who are candidates for second-course treatment 22. Treatment with medications known to cause QTc interval prolongation within the washout periods described in Section 12.10 unless approved by the Amgen medical monitor 23. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. 24. History or evidence of any other clinically-significant disorder, condition, or disease (eg, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrhythmia requiring therapy at time of screening) with the exception of those outlined above that, in the opinion of the investigator or Amgen medical monitor, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
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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, Smoldering Multiple Myeloma Patient has confirmed SMM according to the definition of the International Myeloma Working Group (IMWG) definition: serum M-protein ≥3 g/dL or BMPC >10% but less than 60%, or both, along with normal organ and marrow function (CRAB) within 4 weeks prior to baseline. C: Absence of hypercalcemia, evidenced by a calcium ≤11 mg/dL. R: Absence of renal failure, evidenced by a creatinine ≤ 2.0mg/dL A: Absence of anemia, evidenced by a hemoglobin ≥10 g/dL. B: Absence of lytic bone lesions per IMWG recommendations: One of either PET-CT, low-dose whole-body CT (LDWBCT) or MRI of the whole body or spine. Increased uptake on PET-CT alone is not adequate for the diagnosis of multiple myeloma; evidence of underlying osteolytic bone destruction is needed on the CT portion of the examination. 2. One of the risk factors below that portends for an increased risk of progression to MM An abnormal free light chain ratio M-spike ≥ 4 g/dL ≥ 50% bone marrow plasma cells Immunoparesis ≥ 20% less than the institutional normal standard of the uninvolved immunoglobulins 3. Serum calcium or albumin-adjusted serum calcium ≥ 2.1 mmol/L (8.4 mg/dL) and ≤ 2.9mmol/L (11.5 mg/dL) (Reference range 8.5-10.8 mg/dL) 4. Able to tolerate daily supplementation of calcium and vitamin D 5. Must have a vitamin D level ≥ 30 ng/mL after repletion 6. Participants must have normal organ as defined below Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN); patients diagnosed with Gilbert's syndrome can enroll with a total bilirubin > 2 after review of the principal investigator AST(SGOT) ≤2.5 × institutional ULN ALT(SGPT) ≤2.5 × institutional ULN 7. Age ≥ 18 years. 8. ECOG PS ≤1 9. Life expectancy greater than 12 months 10. Subjects with reproductive potential must be willing to use, in combination with his/her partner, 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after the study duration. Subjects who are surgically sterile (e.g. history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g. history of vasectomy) are not required to use additional contraceptive measures. 11. Ability to understand and the willingness to sign a written informed consent document. -Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 12. Statement on of Women and Minorities Men and women of all ethnicities and racial backgrounds are eligible for this study Prior administration of denosumab. 2. Any history of IV bisphosphonate use prior to or during the study 3. Prescription oral fluorides or bisphosphonate usage > 3 months within the past 2 years 4. Systemic corticosteroids > 10mg prednisone per day 5. Known secondary cause for osteopenia or osteoporosis 6. Patient has symptomatic MM, as defined by any of the following Lytic lesions or pathologic fractures Anemia (hemoglobin <10 g/dL) Hypercalcemia (corrected serum calcium > 11.0 mg/dL) Renal insufficiency (creatinine > 2.0 mg/dL) Clonal bone marrow plasma cells > 60% An involved serum free light chain (kappa or Lambda) > 100mg/L with the ratio of the involved/uninvolved free light chains also > 100 mg/L One or more osteolytic lesions on radiography, but more than one lesion is required if < 10% marrow plasma cells. From MRI imaging, there must be more than one lesion of > 5mm in size. 7. Other: symptomatic hyperviscosity, amyloidosis, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein) 8. Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw. 9. Active dental or jaw condition that requires oral surgery, including tooth extraction. 10. Non-healed dental/oral surgery, including tooth extraction. 11. Planned invasive dental procedures during the course of study. 12. Evidence of any of the following conditions per subject self-report or medical chart review Any prior invasive malignancy within 3 years of enrollment that may affect outcome of study Any non-invasive malignancy not treated with curative intent or with known active disease within 3 years before enrollment that may affect outcome of 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, Myocardial Fibrosis End Stage Renal Failure on Dialysis Chronic Kidney Disease, Stage IV (Severe) Chronic Kidney Disease Stage V Heart Failure Patients with a diagnosis of Chronic Kidney Disease stage 4 and above 2. Patients with a progressive decline in renal function with a expectation to require future renal replacement therapy or currently on renal replacement therapy (Haemodialysis or Peritoneal Dialysis) 3. of macrovascular cardiac disease within the last 3 years 4. Access for haemodialysis planned via tunnelled central venous catheter Age under eighteen 2. Patients with a diagnosis of Diabetes Mellitus 3. Untreated macrovascular cardiac disease or Acute Coronary syndrome within 6 months of recruitment 4. Previous or current treatment with immunosuppressive/modulatory therapy 5. Current Malignancy 6. Current use of Metformin 7. Pregnancy 8. Contraindication to MRI Imaging 9. Patients lacking capacity or unable to consent and non-English language speakers 10. Immediate modality switch after commencement on renal replacement therapy i.e. transplantation 11. Plan for treatment centre change/move outside of Imperial College Healthcare NHS Trust following commencement on renal replacement therapy 12. Patients currently participating in an active CTIMP trial
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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 Multiple myeloma patients with early relapse after intensive front-line treatment and disease measurable by serum biomarkers, who have obtained at least a VGPR after second-line salvage treatment Able and willing to provide written informed consent Able to comply with study protocol and procedures Performance status scores: Eastern Cooperative Oncology Group (ECOG) < 2 and Karnofsky > 70% Life expectancy of ≥ 6 months Adequate cardiac, renal, hepatic and pulmonary functions as evidenced by (at screening and prior to conditioning) Left ventricular ejection fraction (LVEF) ≥ 45% by echo and normal electrocardiogram (ECG) or presence of abnormalities not significant for cardiac disease. Absence of severe pulmonary hypertension Diffusing capacity of the lung for carbon monoxide (DLCO) >50% and forced expiratory volume in 1 sec (FEV1) and forced expiratory vital capacity (FVC) > 60% predicted (if non cooperative: pulse oximetry > 95 % in room air) Serum creatinine < 2x ULN and estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73m2 Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN, and total bilirubin ≤ 2.0 mg/dl Use of other investigational agents within 4 weeks prior to experimental treatment (within 6 weeks if use of long-acting agents) Severe active viral, bacterial, or fungal infection at evaluation Active autoimmune disease or a clinically relevant autoimmune manifestations, requiring immunosuppressive treatment, i.e. psoriasis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis, immune-mediated peripheral neuropathies Active sarcoidosis requiring steroid or other immunosuppressive treatment Primary amyloidosis History of neuropsychiatric illness including severe depression, schizophrenia, bipolar disorders, impaired cognitive function, dementia or suicidal tendency Neuropathy > grade 2 History of severe cardiovascular disease such as prior stroke, coronary artery disease requiring intervention, unresolved arrhythmias Malignant neoplasia (except local skin cancer or cervical intraepithelial neoplasia) or family history of familial cancer syndromes Myelodysplasia, cytogenetic or molecular alterations specifically associated with clonal hematopoiesis of the myeloid lineage, or other serious hematological disorder other than the plasma cell dyscrasia
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Acute Myeloid Leukemia Patients over the age of 18 at time of diagnosis or at time of relapse of disease 2. Patients with Acute Myeloid Leukaemia (excluding M3) at presentation, remission or with refractory or relapsed disease. 3. Patients must have given informed written consent to participate in this study Uncontrolled systemic infection 2. Currently receiving corticosteroids or other immune-suppressants treatment (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency) 3. Treatment with bisphosphonates, for instance zoledronate, in the previous 3 months or throughout the trial 4. Active, known or suspected autoimmune disease such as Ulcerative Colitis / Inflammatory bowel disease, Addison's disease 5. Pregnancy or lactation before or during the study 6. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study 7. Patients with active Hepatitis B, C or HIV will be excluded from this 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): 18.0-65.0, Multiple Myeloma Patient at least 18 years of age and ≤ 65 years Patient eligible for autologous stem cell transplantation (ASCT) Left Ventricular Ejection Fraction (LVEF) ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available Newly diagnosed multiple myeloma patient Patient has given voluntary written informed consent before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care Patient with documented multiple myeloma and measurable disease as defined by Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytoma Measurable disease as defined by at least one of the following serum M-protein level ≥1 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio Patient with a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering MM or Plasma Cell Leukemia (PCL). Monoclonal gammopathy of undetermined significance is defined by presence of serum M-protein <3 g/dL, clonal bone marrow plasma cells <10%, and absence of end-organ damage or amyloidosis that can be attributed to the plasma cell proliferative disorder. Smoldering multiple myeloma is defined as serum monoclonal protein ≥ 30 g/L or urinary monoclonal protein ≥ 500 mg per 24 h and/or clonal bone marrow plasma cell 10-60% with absence of related organ or tissue impairment or end-organ damage or amyloidosis. Plasma cell leukemia is defined as presence of circulating plasmacells (PCs) >2×109/L in peripheral blood or a peripheral blood plasmacytosis >20% Patient with a diagnosis of Waldenström's disease, or other conditions in which immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Patient has prior or current systemic therapy or SCT for multiple myeloma, 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 Patient has peripheral neuropathy of grade 2 or higher as defined by National Cancer Institute Common Toxicity (NCI CTC) 4.0 Patient is exhibiting clinical signs of meningeal involvement of multiple myeloma Clinical active infectious hepatitis type A, B, C or HIV Subject has known chronic obstructive pulmonary disease (COPD) (defined as a Forced Expiratory Volume In 1 second (FEV1) <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years. Subjects with known or suspected COPD or asthma must have a FEV1 test during screening 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 Known allergy to any of the study medications, their analogues, or excipients in the various formulations Contraindication to any of the required concomitant drugs or supportive treatments
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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, Dialysis Quality of Life Nutrition end-stage kidney disease patients treated with dialysis (peritoneal dialysis or hemodialysis) active inflammation malignancy cognitive disorder not understanding the dutch language
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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, Large Vessel Vasculitis A new diagnosis of LVV or a known diagnosis of LVV presenting with disease relapse Predominantly cranial symptoms LVV secondary to other conditions Treatment with high dose glucocorticoids for >2 weeks at time of recruitment Contraindication to MR or PET Unable to travel to Edinburgh Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 Unable to provide informed consent Pregnant or breastfeeding
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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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine 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 B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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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 Hyperparathyroidism Hypercalcemia Diagnosis of primary hyperparathyroidism Non-localizing SPECT-CT performed within 365 days prior to consent to participate in study Patient desires surgical intervention for treatment of PHPT No contraindications to 99mTC-Sestamibi No contraindications to treatment with calcitonin Serum calcium level prior to non-localizing SPECT-CT is ≥10.5 mg/dL Patient consents to participate and undergo second SPECT-CT for purposes of research Previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary Contraindication to 99mTC-Sestamibi SPECT-CT as evidenced by allergic reaction or adverse event during index SPECT-CT Allergy to calcitonin Hypocalcemia (contraindication to calcitonin) Vitamin D deficiency (contraindication to calcitonin) Previous treatment with radioactive iodine New prescription of thyroid medication (levothyroxine, armour thyroid tablets, etc. must be taken at time of index scan and research scan) Lithium exposure within one year of SPECT-CT (index and research scans) Secondary hyperparathyroidism Benign familial hypocalciuric hypercalcemia
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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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
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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, Myeloma Multiple Lymphoma years or older written informed consent diagnosis of malignant lymphoma or multiple myeloma require chemotherapy plus autologous stem cell transplantation as standard of care for the disease at that stage central venous catheter in place or planned inability to understand the nature and extent of the trial and the procedures required history of kidney stones kidney failure requiring dialysis or eGFR <30 mL/min. (CDK-EPI formula) history of G6PD deficiency life expectancy < 1 month use of immunosuppressive medication other than chemotherapy and corticosteroids
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, Amyloidosis Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling Immunolabeling Amyloidosis typing 1. impossible (no frozen sample available) 2. or inconclusive (doubtful) 3. or inconsistent with clinical, biological, genetic and iconographic data Signature of the informed consent form Insufficient tissue material to perform the new technique Person placed under judicial protection Pregnant and breastfeeding women
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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, Myeloma Multiple Able to adhere to the study visit schedule and other protocol requirements >VGPR/MRD-positive by NGF measured by 2-tubes optimized 8-color antibody panel, (OneFlow PCST e PCD BD Biosciences) Patients should be at enrollment at least 12 weeks from any therapy for myeloma after diagnosis or at any subsequent relapse Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 Laboratory values and electrocardiogram within protocol-defined parameters at screening All previous MM therapy, including radiation, cytostatic therapy and surgery, must have been terminated at least 4 weeks prior to treatment in this study, without corticosteroid therapy Laboratory test results within these ranges Absolute neutrophil count 1.0 x 109/L Platelet count 75 x 109/L Creatinine clearance > 30 ml/h) 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 Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years Absence of the Informed Consent Form signed by the patient Pregnant or breast feeding females Use of any other experimental drug or therapy within 28 days of baseline Known hypersensitivity to the study drugs Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
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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, Systemic Amyloidosis PET/MR Patient with Monoclonal Ganunopathy, adds one of the following Histologically confirmed Amyloidosis of any organ Average left ventricular thickness of the echocardiogram is more than 11 mm without uncontrolled high blood pressure lead ECG shows unexplained low voltage <0.5 mV Patient can not lie flat NYHA Level 4 Heart Failure Patient is pregnant or nursing Patient is allergic to amyloid PET imaging agents Patient with acute systemic diseases and electrolyte disorders Patient with severe claustrophobia or unstable vital sigh Other serious comorbidities evaluated by primary investigator
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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): 18.0-55.0, Clinically Isolated Syndrome Relapsing Remitting Multiple Sclerosis A diagnosis of clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) or CIS according to the 2010 McDonald's confirmed by the treating neurologist within 12 months of completing the first study visit.2) Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.3) Must reside within the lower 48 states within the United States.4) Agreement by the treating neurologist that the patient may enroll in the study Moderate or severe mental impairment as measured by the Short Portable Mental Health Questionnaire. 2) Presence of a contraindication to completing a brain MRI or having claustrophobia which interferes with completion of MRI studies without the use of sedation. 3) Taking insulin or Coumadin® medication. 4) History of oxalate kidney stones, schizophrenia, or active diagnosis of eating disorder. 5) Greater than 12 months since initial diagnosis of RRMS or CIS and first study visit
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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 according to the IMWG criteria Detectable osteolysis on low dose CT (at least 5 mm in size) Stable disease, defined as no signs of progressive disease for three months without anti myeloma treatment Achieved, partial response or better, during last line of therapy Signed informed consent Age ≥ 18 years Remaining life expectancy ≥ 6 months ECOG performance status 0-2. Female patients who Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR Treatment with Denosumab within the last 4 weeks Known concurrent malignancy (last five years), excluding skin cancer Known hypersensitivity to Ixazomib Central nervous system involvement Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive Pregnant or lactating women Absolute neutrophil count < 1,000mm3 without growth factor support Platelet count < 75,000/mm3. Platelet transfusions to help patients meet are not allowed within 3 days before -Total bilirubin > 1.5 x the upper limit of the normal range Alanine aminotransferase > 3 x upper limit of the normal range Calculated creatinine clearance < 30 mL/min (using the Cockcroft-Gault equation) Total bilirubin > 1.5 the upper limit of the normal range (ULN)
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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): 40.0-70.0, Multiple System Atrophy, Cerebellar Variant (Disorder) Patients who meet the clinical for probable multiple system atrophy with cerebellar features (MDS second consensus statement on the diagnosis of multiple system atrophy) Patients aged between 40 and 70 Patients who do not have rigidity and bradykinesia Patients who have given voluntary consent after understanding the content of the clinical trial Patients with a serious cognitive disorder, behavioral disorder, or mental illness Patients have history of seizure, stroke, encephalitis, other degenerative neurological disease Patients with a serious medical disease Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease Patients with un-controlled high blood pressure or diabetes Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
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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 Multiple Myeloma in Relapse Patients with relapsed and relapsed refractory myeloma may be eligible for this trial of they meet all the following entry criteria Previously diagnosed with MM based on standard IMWG and currently requires treatment Patient has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Patient had received at least two previous therapies OR received 1 prior line of therapy if previously treated with an IMiD plus a proteasome inhibitor and has demonstrated disease progression on or within 60 days of completion of the last therapy Patient has measurable disease defined as at least one of the following according to Standard Diagnostic (Rajkumar 2014) Serum IgG, IgA, or IgM M-protein ≥ 0.5 g/dL, or Serum IgD M-protein ≥ 0.05 g/dL, or Urine M protein ≥200 mg/24 hours or Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65) Screening Laboratory evaluations within the following parameters Prior exposure to ixazomib OR is refractory to pomalidomide Patients that have previously been treated with ixazomib, or participated in a study with ixazomib,whether treated with the agent or not, are also excluded Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy Known GI disease or is in need of, or has had a previous GI procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide including difficulty swallowing Known central nervous system involvement Systemic treatment, within 14 days before the first dose of treatment, with strong CYP3A or inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort OR systemic treatment within 14 days of the first dose of treatment with a strong inhibitor of CYP1A2 (ciprofloxacin, fluvoxamine, cimetidine, enoxacin, ethynyl estradiol, mexiletine) Any medical or psychiatric illness/social situation that in the Investigator's opinion, would impose excessive risk to the patient, would adversely affect his/her participating in this study or would limit compliance with study requirements Any active, or uncontrolled cardiovascular conditions, including but not limited to uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction within the past 6 months The following therapies within the stated time frames prior to initiation of therapy
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2
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-70.0, Venous Thromboembolism Signed written informed consent Subjects must have documented newly diagnosed symptomatic multiple myeloma requiring front-line treatment Patients should be considered transplant-eligible Subjects will receive front-line induction therapy with a triplet regimen consisting of bortezomib, thalidomide and dexamethasone (VTD) To enter to the study at the same time of start anti myeloma induction therapy Ages eligible for study: 18 to 70 years Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 Patients with the diagnosis of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome or amyloidosis of light chain Patients with smouldering multiple myeloma or monoclonal gammopathy of undeterminated significance Patients considered non-transplant-eligible Grade ≥2 of peripheral neuropathy Prior history of documented any venous thromboembolism and arterial thrombosis event Active or high risk of bleeding Need for on-going anticoagulant or antiplatelet treatment Contraindication of anticoagulant prophylaxis Uncontrolled hypertension: systolic blood pressure >200 mmHg and/or diastolic blood pressure >100 mmHg HIV, HBV or HCV-positive active
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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, Waldenstrom Macroglobulinemia DASATINIB Participants must meet the following on screening examination to be eligible to participate. Screening evaluations including consent, physical exam, and laboratory assessments will be done within 30 days prior to Cycle 1 Day 1. Bone marrow biopsy & aspirate, and CT C/A/P will be done within 90 days prior to Cycle 1 Day 1 Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia Known tumor expression of mutated MYD88 performed by a CLIA certified laboratory Participants must have a BTKCys481 and/or PLCγ2 mutation. Genomic alterations must be confirmed via sequencing performed at NeoGenomics Laboratories At least one previous therapy, with ibrutinib as the most recent treatment. Participants may remain on ibrutinib therapy during screening. A 1 day washout before starting dasatinib is required Documented disease progression on last regimen (ibrutinib) per the Sixth International Workshop on WM. One or more of the following increase in serum IgM level with at least 500 mg/dL absolute increase from nadir with re-confirmation Progression of clinically significant disease related symptoms Symptomatic disease meeting for treatment using consensus panel from the Second International Workshop on WM [26]. One or more of the following Constitutional symptoms Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study Lactating or pregnant women Participants who are receiving any other investigational agents Prior therapy with BCR-ABL inhibitors Known CNS lymphoma Symptomatic hyperviscosity requiring urgent therapy Human Immunodeficiency Virus (HIV), active infection with Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pleural or pericardial effusion, unstable angina pectoris, cardiac arrhythmia, QT Prolongation, or psychiatric illness/social situations that would limit compliance with study requirements Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) History clinically significant ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes
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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 (For full list of see study protocol) Male or female, age 18 years or older at the time of signing the informed consent Proven histochemical diagnosis of AL amyloidosis based on tissue specimens with Congo red staining At least one prior line of therapy, defined as either one non-transplant regimen, one ASCT (autologous stem cell transplantation), or one regimen of induction therapy followed by a single ASCT. No more that 4 cycles of melphalan containing chemotherapy is allowed Measurable hematologic disease Objectively measurable organ amyloid involvment ECOG performance status ≤ 2 (ECOG = Eastern cooperative oncology group) Women of child bearing potential must have a negative serum or urine pregnancy test Less than 30% plasma cells in bone marrow aspirate or biopsy Acceptable laboratory results met (absolute neutrophil count (ANC), platelet count, hemoglobin, total bilirubin,alkaline phosphatase, AST (aspartate aminotransferase) and ALT (alanine aminotransferase), renal function) (For full list of see study protocol) Amyloidosis due to known mutations of the transthyretin gene or presence of another non-AL amyloidosis Evidence of gastro-intestinal bleeding Cardiac risk stage 3 Low platelets value with evidence of mucosal or internal bleeding Medical documented cardiac syncope, NYHA Class 3 or 4 congestive heart failure, myocardial infarction, unstable angina pectoris, clinically significant ventricular arrhythmias (NYHA=New York Heart Association Functional Classification) Clinically significant finding on 24 h Holter recording Severe orthostatic hypotension Clinically significant factor X deficiency
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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 Relapse Multiple Myeloma Diagnosed as multiple myeloma Patients signed informed consent form Patients received no more then 2 lines of therapy Patients below 18 years old
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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, Renal Insufficiency,Chronic Patients are eligible to be included in the study only if they meet the following 1. Male or Female, 18 years or older 2. Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for hemodialysis 3. Native [autogenous tissue] AV fistula creation or access is not indicated or non-viable [disadvantaged veins] 4. Requiring repair of an existing fistula or conduit, but only if using Artegraft as an interposition placement and the Artegraft is cannulated [not the fistula]. Artegraft must be place in a fresh subcutaneous tunnel. Thigh loop grafts will not be used. 5. Able to accommodate vascular graft placement in the upper extremity (i.e., forearm, or upper arm) 6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) 7. Able and willing to comply with the study protocol 8. Agrees to initiate and maintain hemodialysis treatments 9. Life expectancy is > 1 year based on physician assessment Patients are excluded from the trial if any of the following apply: 1. High grade central venous stenosis/occlusion 2. Breast-feeding, pregnant or planning pregnancy within next 12 months. 3. Non-resolved infected existing grafts 4. Documented sepsis/bacteremia by blood culture within 4 weeks of implantation. 5. History of non-controlled immunodeficiency syndrome, including AIDS/HIV; Active clinically significant immune-mediated disease, not controlled by low-dose maintenance immunosuppression. The diagnosis of HIV alone, provided adequately treated, is not a contraindication for enrolment. 6. Severe liver dysfunction and/or coagulation or bleeding disorders. 7. Elevated platelet count > 1 million cells/mm3 8. History of heparin-induced thrombocytopenia syndrome (HIT) 9. Documented hypercoagulable state 10. Currently participating in another investigational drug or device study which may clinically interfere with any endpoints of this trial 11. Known hypersensitivity or contraindication to device materials or procedural medications that cannot be adequately managed medically 12. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), , myocardial infarction within 6 months of enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina, uncontrolled CHF 13. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis) 14. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin 15. Bleeding diathesis, other than that associated with ESRD 16. Scheduled renal transplant within 6 months 17. Patients who require chronic anticoagulation except for antiplatelet therapy. Patients currently receiving or who have received within the last month direct thrombin inhibitors, factor Xa inhibitors, or vitamin K antagonists should not be included in the 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, Multiple Myeloma Willing and able to provide written informed consent At least 18 years of age Clinical diagnosis of multiple myeloma that meets published diagnostic Initiating panobinostat within 60 days of enrollment ECOG performance status 0-1 Availability of documentation from the patient's medical records regarding previous myeloma treatment, response, and duration of response Willing and able to complete the PRO questionnaire Diagnosed with any B-cell malignancy other than myeloma Estimated life expectancy <6 months Currently enrolled in any interventional clinical trial at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry)
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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): 0.0-110.0, Diabetes Mellitus, Type 2 Artery Disease Protein Deposition Coronary artery bypass surgery performed at Odense University Hospital Useful sample of internal mammary artery Willingness to participate Other cardiac surgery performed Withdrawal of 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, Relapsed and Refractory Multiple Myeloma Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease Documented measurable disease Adequate organ function Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1 Plasma Cell Leukemia or History of Plasma Cell Leukemia Patients with a history of severe hypersensitivity to DMSO should be excluded Contraindication to fludarabine or cyclophosphamide Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities Active central nervous system disease involvement by malignancy or active CNS pathology
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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): 18.0-80.0, Multiple Myeloma Refractory Multiple Myeloma Multiple Myeloma in Relapse Relapse Men or women ≥ 18 and ≤ 80 years old Diagnosis of multiple myeloma Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio Previously treated relapsed and refractory multiple myeloma Patients must have received at least one prior line of therapy Prior therapy must at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen) Disease progression on or within 60 days of completion of last therapy ANC ≥ 1000/μL Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study registration or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received dexamethasone within 2 weeks prior to study registration Participants who are receiving any other investigational agents Last line of therapy with the combination of carfilzomib, pomalidomide, and dexamethasone. Note, prior treatment with daratumumab or other anti-CD38 therapy is permitted. Prior treatment with carfilzomib or pomalidomide is permitted (as different lines of treatment but not in the same combination) Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose 10 mg/day prednisone equivalent) is permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc Pregnancy or lactation or planned lactation (breastfeeding) Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for ≥ 3 years. Patients who are free of disease < 3 years may enroll after discussion with and approval of the PI. Exceptions the following (i.e. the following are eligible to participate) Basal or squamous cell carcinoma of the skin Carcinoma in situ of the cervix Ductal carcinoma in situ of the breast Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance
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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): 18.0-90.0, Psoriasis Vulgaris Psoriasis vulgaris patients patients that don't want to answer questions
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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, AL Amyloidosis Plasma Cell Dyscrasia Male or female aged 18-75 years Patients with newly diagnosed AL Appropriate for autologous hematopoietic stem cell transplantation Abnormal M protein or free light chain detected in serum and/or urine ECOG score 0-2 points Subjects (or their legal representatives) must sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study Pregnant and breastfeeding women Subjects suffering from multiple myeloma hypersensitivity to any treatment drugs Subjects have severe cardiovascular disease Subjects have a serious physical disease and mental illnesses Other conditions that researchers consider are not suitable for transplantation
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1
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-999.0, End Stage Renal Disease Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month years old and older Vascular access by arteriovenous fistula/graft Creatinine clearance of more than 2 ml/min Agreement to participate in the clinical study Dialysis through permanent catheter Plan for kidney transplantation within 6 months Severe volume overloading state Any hematologic malignancy or monoclonal gammopathy Any malignancy Active infectious disease HIV infection Patient enrolled to another study within 3 month from starting the present 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): 0.0-999.0, Arterio-venous Fistula All renal failure patients requiring creation of arm AVF Including distal Radio-cephalic, Ulno-basilic, proximal brachio-cephalic or brachio-basilic configurations Revision AVF, Synthetic graft AVF or lower limb AVF Patients with absent distal pulses and chronic ischemia of the upper limb Recent cannulation of puncture of the vein within 2 weeks before its use in AVF creation
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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, Ventricular Assist Device Self-management Psychological Factors Outpatient at the respective heart center Living in a home environment On device between 3 months and 3 years years and older No contraindications (e.g. cognitive, language) Signed Informed Consent In-patient stay Not living in a home environment (e.g. assisted living) On device less than 3 months or more than 3 years Underage Contraindications (e.g. cognitive, language) No signed 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): 0.0-18.0, Traumatic Brain Injury Brain Injuries Brain Injury, Vascular Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas Acute presentation (< 24 hour) onset of neurologic injury Acute neurologic injury can be due to any of the following mechanisms Severe accidental or abusive traumatic brain injury Severe encephalopathy secondary to cardiac arrest Spontaneous intracranial hemorrhage Status epilepticus Stroke Presence of or pending placement of invasive indwelling arterial line for stand medical care Any patient with an ICP monitor placed as standard of care Patients without an arterial line placed as standard of care Patients unable to cooperate with wearing a TCD headpiece device Expected death within 24-48 hours Inability to place NIRS probes or insonate TCD signal due to massive facial or cranial injury Receiving an inhalational anesthetic agent Hemoglobinopathy, myoglobinemia or and hyperbilirubinemia (due to inaccurate NIRS readings)
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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 Key 1. Age ≥18 years. 2. Relapsed or refractory multiple myeloma, as defined by IMWG response and treatment with at least 2 prior lines of therapy. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 4. Adequate renal, liver, cardiac and pulmonary organ function 5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX120 infusion. Key Prior allogeneic stem cell transplant (SCT). 2. Less than 60 days from autologous SCT at time of screening and with unresolved serious complications. 3. Prior treatment with any gene therapy or genetically modified cell therapy, including CAR T cells or natural killer cells, or BCMA-directed therapy. 4. Evidence of direct central nervous system (CNS) involvement by multiple myeloma. 5. History or presence of clinically relevant CNS pathology such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement. 6. Unstable angina, clinically significant arrhythmia, or myocardial infarction within 6 months of enrollment. 7. Active HIV, hepatitis B virus or hepatitis C virus infection. 8. Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years. 9. Use of systemic anti-tumor therapy or investigational agent within 14 days prior to enrollment. 10. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 11. Women who are 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): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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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, Multiple Myeloma All patients being treated for multiple myeloma receiving their first oral anticancer treatment All patients being treated for multiple myeloma by autologous peripheral stem cell graft following the Revlimid Velcade Dexamethazone protocol All patients who cannot be treated for multiple myeloma by autologous peripheral stem cell graft and who are following the Revlimid Dexamethazone protocol All patients who have given written informed consent All patients who have signed the consent form All patients covered by a health insurance scheme All patients requiring help at home from a nurse for taking their oral treatment All patients participating in another category 1 research project All patients in an period determined by another study All patients for whom it is impossible to give enlightened information All patients who are 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, Plasma Cell Myeloma Renal Failure Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Creatinine clearance < 30 mL/min by Cockcroft-Gault (C-G), 24 hour urine collection or the Modification of Diet in Renal Disease (MDRD) methods. The same method used for will be used for renal response assessment Documented multiple myeloma as defined by the International Myeloma Working Group (IMWG) 2014 including: Clonal bone marrow plasma cells >= 10%. In addition, the patient must meet one of the in day (d)1 or d2 Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically (one or more of the following) Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal (ULN) or > 2.75 mmol/L (>11 mg/dL) Renal insufficiency: creatinine clearance (CrCl) < 30 mL/min Anemia: hemoglobin value of > 2 g/dL below the lower limit of normal, or a hemoglobin value < 10 g/L Bone lesions: 1 or more osteolytic lesions on skeletal radiography, computed tomography (CT), or magnetic resonance imaging (MRI) Measurable disease as defined by any of the following Serum M-protein level >= 1.0 g/dL or urine M-protein level >= 200 mg/24 hours Diagnosed with smoldering multiple myeloma (MM), monoclonal gammopathy of undetermined significance, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis or primary or secondary plasma cell leukemia Participant has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination within 21 days before initiation of protocol therapy Plasmapheresis within 28 days Platelet count =< 75,000 cells/mm^3 at time of screening evaluation. Platelet transfusions to help patients meet are not allowed within 3 days before study enrollment Participants with an absolute neutrophil count (ANC) =< 1000 cells/mm^3 at time of screening evaluation. Growth factors may not be used to meet ANC within 14 days of obtaining screening evaluation Participants with hemoglobin level < 7.0 g/dL, at time of screening. Transfusion may be used to meet within 7 days of obtaining screening evaluation Participants with hepatic impairment, defined as bilirubin >= 1.5 x institutional upper limit of normal (ULN) or aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]), or alkaline phosphatase >= 3 x institutional ULN, within 21 days of initiation of protocol therapy Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg p.o. once daily [q.d.] or its equivalent) for symptom management and comorbid conditions. Doses of corticosteroid should be stable for at least 7 days prior to study treatment.) Steroids more than 160 mg IV equivalents of dexamethasone or bortezomib > 2 doses of 1.3 mg/m^2 each dosing equivalents Known significant cardiac abnormalities including
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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): 18.0-95.0, Myeloma Multiple Metastatic Bone Tumor All patients with Active Multiple Myeloma Inability to provide informed consent or lack of consent Inadequate CT scans
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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): 18.0-90.0, Cardiac Amyloidosis presence of data obtained from historical records of patients who retrospectively met the prescriptive (neurological) and received the prescription of the drugs in question (RNA interferences) having Cardiological evaluation (examination ECG, echocardiography) at the time of prescription Cardiological evaluation (examination ECG, echocardiography) evaluated six months after therapy Cardiological evaluation (examination ECG, echocardiography) evaluated 12-18 months after therapy it wasn't possible to putatively confirm the reasonable shipment of the innovative therapy prescribed it wasn't possible to putatively confirm the reasonable shipment of conventional therapy prescribed (background therapy)
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0
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64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function.
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eligible ages (years): 18.0-80.0, Hemodialysis Access Failure Adult hemodialysis patients Significant cardiorespiratory comorbidities Peripheral vascular disease Pregnancy or lactation Severe bleeding disorders
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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, COVID-19 Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O)) Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions: 1. Hypercholesterolemia 2. Hypertriglyceridemia 3. Liver disease 4. Renal disease 5. Sjögren syndrome 6. Pregnancy 7. Lactation 8. Depressive disorder 9. Body mass index less than 18 points or higher than 25 points 10. Contraindications for hormonal contraception or intrauterine device. 11. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation 12. Patients receiving anti-hcv treatment 13. Permanent blindness in one eye 14. History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery 15. The competent physician considered it inappropriate to participate in the study 16. HIV infection or other immunodeficiency or with an absolute neutrophil count ≤1.0 × 109/L 17. Abnormal liver biochemistry (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase) >1.5 × upper limit of normal or total bilirubin > upper limit of normal (unless Gilbert's disease with normal conjugated bilirubin) 18. Any of the following laboratory abnormalities are present at baseline Platelet count <150×109/L Serum albumin ≤ 3.5 g/dL INR ≥1.2 CPK ≥ ULN. 19. Significant liver fibrosis as evidenced by Fibrosis-4 (FIB-4) score >3.25 20. History of hypersensitivity to retinoic acid or any of its excipients or the class of neutrophil elastase inhibitors Known hypersensitivity to medications used in the study procedures (e.g. midazolam, fentanyl, and lidocaine for bronchoscopy)
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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): 45.0-999.0, Cardiac Amyloidosis Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram 2. Age equal or greater than 45 years 3. Current residency in Martinique, Guadeloupe or French Guyana 4. Ability to receive and understand research information 5. Ability to freely deliver informed written consent Pregnant or breastfeeding woman 2. Severe uncontrolled hypertension 3. Chronic hemodialysis 4. Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty
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0
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