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Table 1 Study schema

From: Design and rationale of FOCUS (PX-171-011): A randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM)

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