Randomized phase II study of bortezomib plus dexamethasone (BD) versus thalidomide plus dexamethasone (TD) for relapsed or refractory multiple myeloma (JCOG0904, r II BD vs TD for MM)
Phase 2
- Conditions
- bortezomib- and thalidomide-na&iumlve relapsed or refractory multiple myeloma after one or more prior lines of chemotherapy
- Registration Number
- JPRN-UMIN000003135
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Not provided
Exclusion Criteria
1) synchronous or metachronous malignancy 2) active infection 3) febrile over 38oC 4) pregnant or nursing women 5) psychological disturbance 6) continued treatment with steroids for non-malignant disorders 7) insulin-dependent or uncontrollable diabetes mellitus 8) uncontrollable hypertension 9) HBs-Ag positive or HCV-Ab positive 10) HIV-Ab positive 11) interstitial pneoumonia, pulmonary fibrosis, severe pulmonary edema, or severe pleural effusion on chest CT 12) grade 2 or higher peripheral neuropathy, or grade 1 or higher neuralgia 13) glaucoma 14) allergic history to borate or mannitol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year progression free survival rate
- Secondary Outcome Measures
Name Time Method adverse events, serious adverse events, best response rate, progression free survival, overall survival