(C-SHOT1601)Phase II study of bortezomib plus Lenalidomide and dexamethasone (Once weekly BLd) for elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
Phase 2
- Conditions
- Elderly or transplant-ineligible patients with untreated symptomatic multiple myeloma
- Registration Number
- JPRN-UMIN000022008
- Lead Sponsor
- agoya City University Hospital Division of Hematology & Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- 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 objective response rate, very good PR (VGPR) above
- Secondary Outcome Measures
Name Time Method CR rate overall response (PR above) overall survival progression-free survival adverse event treatment efficacy according to the translocation of chromosome myeloma related