Multicenter clinical trials to determine the efficacy and safety of consolidation and maintenance therapy with ixazomib, lenalidomide, dexamethasone (IRd) therapy in patients with multiple myeloma after autologous stem cell transplantation.
Phase 2
- Conditions
- refractory multiple myeloma
- Registration Number
- JPRN-UMIN000032674
- Lead Sponsor
- Akita University hosipital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1 relapsed myeloma 2 previous treatment history of ixazomib 3 treatment history of some drugs after auto SCT. 4 not tolerable to lenalidomide, bortezomib, dexamethasone 5 with Grade 2 or higher peripheral neuropathy 6 pregnancy 7 Abnormality of blood test 8 CNS involvement 9 Plasma cell leukemia 10 with severe infection 11 with intestinal pneumoniae 12 with double and more cancer 13 without consent of blood transfusion 14 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