Phase I/II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly VRd-21) for relapsed and/or refractory multiple myeloma (Once weekly VRd-21, I/II VRD for MM)
Phase 1
- Conditions
- Proteasome inhibitor and immunomodulatory drug pre-treated relapsed and/or refractory multiple myeloma after two or more prior lines of chemotherapy
- Registration Number
- JPRN-UMIN000013169
- Lead Sponsor
- agoya City University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) synchronous or metachronous malignancy 2) active infection 3) severe constipation or illeus 4) interstitial pneoumonia, pulmonary fibrosis 5) uncontrolled diabetes 6) inability to intake antithrombotic medication 7) pregnant or nursing women mellitus 8) uncontrollable hypertension 9) psychological disturbance 10) active double cancer 11) HBs-Ag positive or HCV-Ab positive or HIV-Ab positive 12) grade 3 or higher peripheral neuropathy, or grade 1 or higher neuralgia 13) glaucoma 14) primary plasma cell leukemia 15) no adminstration of blood transfusion or G-CSF within 7days befor the treatment 16) no evidence of cardiac or intestinal amyloidosis 17) allergic history to borate or mannitol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method maximum tolerated dose objective response rate, PR above
- Secondary Outcome Measures
Name Time Method overall survival progression-free survival time to progression adverse event treatment efficacy according to the translocation of chromosome myeloma related