A phase 2 study of KRd(carfilzomib, lenalidomide, dexamethasone) consolidation for newly diagnosed multiple myeloma
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000032659
- Lead Sponsor
- Ochanomizu Hematology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 21
Not provided
1. MRD in the BM is absent(<10*-4) after ASCT. 2. Patient who has hypersensitivity to the study drugs. 3. Uncontrolled or severe cardiovascular disease, including New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or cardiac amyloidosis. 4. Uncontrolled hypertention. 5. Uncontrolled active infection. 6. Past history of pulmonary embolism, myocardial infarction and cerebral infarction. 7. Past history of deep vein thrombosis, administration of anticoagulants and/or antiplatelet drugs within 3 years 8. HBs antigen positive and/or HCV positive. 9. Administration of HBV reatctivation. 10. Active advanced-stage cancer. 11. Female patient who is pregnant and/or breastfeeding. 12. Active gastrointestinal bleeding. 13. Past history of renal transplantation. 14. Uncontrolled diabetes mellitus. 15. Serious psychiatric illness 16. Patient who is judged to be medically unfit by his/her physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRD negative rate after KRd therapy
- Secondary Outcome Measures
Name Time Method 1)iCR,sCR,CR,VGPR and PR after KRd therapy 2 cycles and 4 cycles 2)Progression free survival(PFS) after induction therapy 3)Overall survival(OS) after induction therapy 4)Incidence of adverse events