Multicenter clinical trials to determine the efficacy and safety of consolidation and maintenance therapy with ixazomib, lenalidomide, dexamethasone (IRd) therapy in transplant-ineligible multiple myeloma.
Phase 2
- Conditions
- refractory multiple myeloma
- Registration Number
- JPRN-UMIN000032675
- Lead Sponsor
- Akita University hosipital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
Not provided
Exclusion Criteria
1 relapsed myeloma 2 previous treatment history of ixazomib 3 not tolerable to lenalidomide, bortezomib, dexamethasone 4 with Grade 2 or higher peripheral neuropathy 5 pregnancy 6 Abnormality of blood test 7 CNS involvement 8 Plasma cell leukemia 9 with severe infection 10 with intestinal pneumoniae 11 with double and more cancer 12 without consent of blood transfusion 13 and other
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of stringent CR achievemnt during the IRd therapy.
- Secondary Outcome Measures
Name Time Method 1 Time to sCR achievement period 2 MRD negativity achievement rate 3 ORR 4 Safety 5 PFS 6 OS 7 pharmacokinetics of lenalidomide, ixazomib