Multiple myeloma
Conditions
Interventions
Consoilidation therapy KRd 4 cycles, every 4 weeks carfilzomib 20mg/m2 only first cycle day1,2 carfilzomib 27mg/m2 day1,2,8,9,15,16 after first cycle day 8 lenalidomide 15mg/body day1-21 dexamet
Sponsors
Ochanomizu Hematology Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Days 90 to 180 after autologous stem cell transplantation for patients with newly diagnosed multiple myeloma. 2. If patients received lenalidomide at induction therapy, they need to be tolerable more than lenalidomide 10 mg/day. 3. Age from 20 to 65 at autologous stem cell transplantation 4. No previous consolidation and maintenance therapy. 5. At least PR after autologous stem cell transplantation. 6. MRD in the BM is present(>=10*-4) after ASCT. 7. ECOG-Performance Status (PS) is 0-2. 8. Patent who meets the following criteria; a) Renal function:Ccr >= 30ml/min (Cockroft-Gault). b) Bone marrow function: ANC >= 1000/uL, Platelet >= 75,000/uL, Hb >= 8.0g/dl c) Liver function: AST,ALT <= 2.5*ULN, T-Bil <= 1.5*ULN d) Heart function: EF >= 50% e) Pulmonary function: SpO2 >= 93% 9. Patient who has Grade <= 2 peripheral neuropathy without pain (NCI CTCAE ver.4). 10. Patient who can agree the registration for RevMate and keep its administrative procedure. 11. Patient who provided written consents for this study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negative rate after KRd therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactDaisuke Kudo
Tokyo-kita Medical Center Department of hematology
Outcome results
None listed