Table 3.
Exposure to study treatment in phase 3 trials
| ASPIRE | ENDEAVOR | FOCUS | ||||||
|---|---|---|---|---|---|---|---|---|
| Carfilzomib |
Lenalidomide | Carfilzomib |
Bortezomib |
Carfilzomib |
BSC | |||
| KRd | KRd | Rd (control) | Kd | Vd (control) | Carfilzomib | Corticosteroid | Cyclophosphamide | |
| n | 392 | 391 | 392 | 463 | 456 | 157 | 153 | 145 |
| Treatment duration, median (range), wk | 72.0 (1.0-93.1) | 85.0 (0.1-185.0) | 56.7 (0.4-200.7) | 39.9 (1.0-108.1) | 26.8 (1.0-106.1) | 16.3 (0.3-138.4) | 10.7 (0.4-138.3) | 10.1 (0.10-138.3) |
| Average dose per administration, median (range)*† | 26.8 mg/m2 (15.3-26.9) | 25.0 mg (6.3-25.1) | 25.0 mg (6.6-25.0) | 55.9 mg/m2 (19.5-59.9) | 1.2 mg/m2 (0.7-1.7) | 26.4 mg/m2 (20.0-26.9) | 65.0 mg (6.6-200.0) | 1 083 mg (36.2-2 567.0) |
| Total dose received during study, median (range) | 2362 mg/m2 (20.0-2902.0) | 7875 mg (25.0-23400.0) | 5825 mg (75.0-26375.0) | 2898 mg/m2 (39.6-8288.0) | 36.3 mg/m2 (1.2-190.9) | 661.0 mg/m2 (40.0-4711.0) | 204 mg (9.0-2868.0) | 3 200 mg (46.1-48 400.0) |
Median PFS (months) for ASPIRE (Kd, 26.3; Vd, 17.6), ENDEAVOR (Kd, 18.7; Vd, 9.4) and FOCUS (K, 3.7; BSC; 3.3).
*
Values for average dose per administration are for the time period beyond cycle 1 in the ENDEAVOR trial.
†
Values represent average dose per cycle (in milligrams) for corticosteroid and cyclophosphamide in the FOCUS trial.