refractory multiple myeloma
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 MM patients with PR, VGPR, CR 2 transplant-ineligible MM patients without the improvement of response depth during the most recent 6 cycles of Ld therapy. 3 with consent 4 measureble M-protein 5 PS 0-2 6 contraceptive
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of stringent CR achievemnt during the IRd therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Time to sCR achievement period 2 MRD negativity achievement rate 3 ORR 4 Safety 5 PFS 6 OS 7 pharmacokinetics of lenalidomide, ixazomib | — |
Countries
Japan
Contacts
Akita University Graduate School of Medicine Department of Hematology, Nephrology, Rheumatology,