Pomalidomide trials in multiple myeloma
| Trials by Reference . | Patient population . | N . | Regimen/dose . | ORR (%) . |
|---|---|---|---|---|
| Phase 1 trials | ||||
| 23 | Relapsed | 24 | Pom dose escalation | 54 |
| MTD 2 mg 28/28 | ||||
| 24 | Relapsed | 20 | Pom ± dex | 50 |
| MTD 5 mg QOD 28/28 | ||||
| 25 | RR/MM | 38 | Pom ± dex | 25 |
| MTD 4 mg 21/28 | ||||
| Phase 2 trials | ||||
| 31 | Len/Btz ref | 120 | Pom ± dex, 4 mg, 21/28 | 25 |
| 26 | Rel, 1-3 reg | 60 | Pom/dex 2 mg, 28/28 | 63 |
| 28 | Len ref | 34 | Pom/dex 2 mg, 28/28 | 47 |
| 30 | Len/Btz ref | 43 | Pom/dex 4 mg, 21/28 | 30 |
| 40 | Pom/dex 4 mg, 28/28 | 47 | ||
| 29 | Len/Btz ref | 35 | Pom/dex 2 mg, 28/28 | 49 |
| 35 | Pom/dex 4 mg, 28/28 | 43 | ||
| 27 | Len ref, 1-3 reg | 60 | Pom/dex 4 mg, 28/28 | 38 |
| Len ref | 120 | Pom/dex 4 mg, 21/28 | 23 | |
| 32 | RR/MM | 52 | Cla/ Pom ± dex, 4 mg, 21/28 | 60 |
| Phase 3 trials | ||||
| 34 | RR/MM | 302 | Pom/dex 4 mg, 21/28 | 31 |
| 153 | HiDex | |||
| 40 mg (≤75 y) | 15 | |||
| 20 mg (>75 y) | ||||
| D 1-4, D 9-12, D 17-20 | ||||
| Combination regimens | ||||
| 37 | RR/MM | 21 | Pom 1-4 mg/d D 1-14 | 72 |
| Btz 1-1.3 mg/m2 D 1, 4, 8, 11 | ||||
| Dex 20 mg/d D 1 and 2, D 4 and 5, D 8 and 9, D 11 and 12 | ||||
| 38 | RR/MM | 32 | Pom and Car dose escalation | 50 |
| MTD: carfilzomib 20/27 mg/m2 | ||||
| Pom 4mg D 1-21 | ||||
| Dex 40 mg weekly | ||||
| 39 | RR/MM | 10 | Pom 2, 3, or 4 mg for 21/28 D | 43 |
| PLD 5 mg/m2 IV on D 1, 4, 8, 11 | ||||
| Dex 40 mg IV weekly | ||||
| MTD: not reached | ||||
| 40 | RR/MM | Pom dose escalation | 54 | |
| MTD 2.5 mg 28/28 | ||||
| Cyclophosphamide 50 mg QOD | ||||
| Prednisone 50 mg QOD | ||||
| Trials by Reference . | Patient population . | N . | Regimen/dose . | ORR (%) . |
|---|---|---|---|---|
| Phase 1 trials | ||||
| 23 | Relapsed | 24 | Pom dose escalation | 54 |
| MTD 2 mg 28/28 | ||||
| 24 | Relapsed | 20 | Pom ± dex | 50 |
| MTD 5 mg QOD 28/28 | ||||
| 25 | RR/MM | 38 | Pom ± dex | 25 |
| MTD 4 mg 21/28 | ||||
| Phase 2 trials | ||||
| 31 | Len/Btz ref | 120 | Pom ± dex, 4 mg, 21/28 | 25 |
| 26 | Rel, 1-3 reg | 60 | Pom/dex 2 mg, 28/28 | 63 |
| 28 | Len ref | 34 | Pom/dex 2 mg, 28/28 | 47 |
| 30 | Len/Btz ref | 43 | Pom/dex 4 mg, 21/28 | 30 |
| 40 | Pom/dex 4 mg, 28/28 | 47 | ||
| 29 | Len/Btz ref | 35 | Pom/dex 2 mg, 28/28 | 49 |
| 35 | Pom/dex 4 mg, 28/28 | 43 | ||
| 27 | Len ref, 1-3 reg | 60 | Pom/dex 4 mg, 28/28 | 38 |
| Len ref | 120 | Pom/dex 4 mg, 21/28 | 23 | |
| 32 | RR/MM | 52 | Cla/ Pom ± dex, 4 mg, 21/28 | 60 |
| Phase 3 trials | ||||
| 34 | RR/MM | 302 | Pom/dex 4 mg, 21/28 | 31 |
| 153 | HiDex | |||
| 40 mg (≤75 y) | 15 | |||
| 20 mg (>75 y) | ||||
| D 1-4, D 9-12, D 17-20 | ||||
| Combination regimens | ||||
| 37 | RR/MM | 21 | Pom 1-4 mg/d D 1-14 | 72 |
| Btz 1-1.3 mg/m2 D 1, 4, 8, 11 | ||||
| Dex 20 mg/d D 1 and 2, D 4 and 5, D 8 and 9, D 11 and 12 | ||||
| 38 | RR/MM | 32 | Pom and Car dose escalation | 50 |
| MTD: carfilzomib 20/27 mg/m2 | ||||
| Pom 4mg D 1-21 | ||||
| Dex 40 mg weekly | ||||
| 39 | RR/MM | 10 | Pom 2, 3, or 4 mg for 21/28 D | 43 |
| PLD 5 mg/m2 IV on D 1, 4, 8, 11 | ||||
| Dex 40 mg IV weekly | ||||
| MTD: not reached | ||||
| 40 | RR/MM | Pom dose escalation | 54 | |
| MTD 2.5 mg 28/28 | ||||
| Cyclophosphamide 50 mg QOD | ||||
| Prednisone 50 mg QOD | ||||
Abbreviations: 21/28, 21 days of a 28-day cycle; 28/28, 28 days of a 28-day cycle; Btz, bortezomib; D, days; dex, dexamethasone; HiDex, high-dose dexamethasone; Len ref, lenalidomide, refractory; Len/Btz ref, lenalidomide and bortezomib refractory; MTD, maximum tolerated dose; N, number of patients; ORR, overall response rate; PLD, pegylated doxorubicin; Pom, pomalidomide; QOD, every other day; Rel, 1-3 reg, relapsed with 1-3 prior regimens; RR/MM, relapsed refractory multiple myeloma.