The single-arm phase II study evaluating pomalidomide-plus-dexamethasone for relapsed/refractory multiple myeloma and phase II study evaluating pomalidomide-bortezomib-dexamethasone for the patients who are not able to achieve PR after pomalidomide-plus-dexamethasone therapy
- Conditions
- Relapse and Refractory Multiple Myeloma
- Registration Number
- JPRN-UMIN000028488
- Lead Sponsor
- Gunma University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate of 4 cycles of pomalidomid+dexamethasone therapy
- Secondary Outcome Measures
Name Time Method 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