Table 1

Study schema
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)

D, day; ECOG, Eastern cooperative oncology group; IV, intravenous; PO, oral; QD, every day; QOD every other day.

Hájek et al.

Hájek et al. BMC Cancer 2012 12:415   doi:10.1186/1471-2407-12-415

Open Data