Relapse and Refractory Multiple Myeloma
Conditions
Interventions
Pomalidomide, Dexamethasone PomD Pomalidomide, Bortezomib, Dexamethasone PBd
Sponsors
Gunma University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Relapsed/refractory multiple myeloma diagnosed according to IMWG criteria and previously treated with bortezomib and lenalidomide. 2. Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment) a.Serum M-protein > 0.5g/dL, or b.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. Can receive up to 4 lines of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment) 4. 20 years old or more 5. ECOG Performance status 0 or 1 or 2 6. Patients must meet the following clinical laboratory criteria with 21 days of starting treatment a. Absolute neutrophil count (ANC) >1,000/mm3 and platelet >50,000/mm3 (>30,000/mm3 if myeloma involvement in the bone marrow is >50%) b. Total bilirubin<1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3 x ULN. c. Calculated creatinine clearance > 30mL/min or creatinine < 3mg/dL. 7. adhere to RevMate 8. written informed consent
Exclusion criteria
Exclusion criteria: 1.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.Waldenstroms Macroglobulinaemia 7.Patients with known amyloidosis 8.Patients with GVHD 9.Patients with cataract 10.Glucocorticoid>30mg/day 14 days prior to obtaining informed consent 11,Chemotherapy with approved within 21 days prior to starting pomalidomide treatment 12.Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide 13.Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide 14.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 15.HBs antigen positive, HCV antibody positive, HIV antibody positive 16.malignancy within the past 3 years except: a.Adequately treated basal cell or squamous cell skin cancer b.Carcinoma in situ of the cervix c.Breast carcinoma in situ with full surgical resection 17.Patients with steroid or lenalidomide hypersensitivity 18.Prior treatment with pomalidomide 19.Peripheral neuropathy > Grade 2 20.Un-controlled liver dysfunction, renal dysfunction, heart failure, lung dysfunction, diabetes, hypertension 21.active infection 22.Myocardial infarction within 4 months or deep vein thrombosis, pulmonary embolism within 3 years prior to informed consent 23.interstitial pneumonitis, pulmonary fibrosis, abnormal interstitial shadow by CT scan 24.inappropriate for study by any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate of 4 cycles of pomalidomid+dexamethasone therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate of bortezomib+pomalidomid+dexamethasone (BPd) stringent complete response (sCR) Complete response (CR) Overall response (more than PR) 2 years progression free survival 3 years progression free survival 2 years overall survival 3 years overall survival median progression free survival adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Handa
Gunma University Hospital Division of Hematology
Outcome results
None listed