Eligibility criteria | Randomization | Treatment arms | Follow-up |
---|---|---|---|
- Measurable multiple myeloma | Randomized 1:1 | Carfilzomib | - Confirmed disease progression |
- ECOG performance status 0-2 | Stratified based on: | Cycle 1: | - Long-term follow-up assessments every 8 weeks until death or study closure |
- ≥3 prior therapeutic regimens | - 3 vs 4 vs ≥ 5 therapies | 20 mg/m2 IV D 1,2 | |
- Responsive to ≥1 line of therapy | - Europe vs non-Europe | 27 mg/m2 IV D 8, 9, 15, 16 | |
- Relapsed while on or after 1 therapy | Cycle 2-9: | ||
- Refractory to most recent regimen | 27 mg/m2 IV D 1, 2, 8, 9, 15, 16 | ||
Cycle ≥10: | |||
27 mg/m2 IV D 1, 2, 15, 16 | |||
Best Supportive Care Regimen | |||
Prednisolone 30 mg QOD | |||
OR | |||
Dexamethasone 6 mg PO QOD | |||
plus optional | |||
Cyclophosphamide 50 mg PO QD | |||
(max 1400 mg/cycle) |