Table 1. Summary of available clinical efficacy data of pomalidomide in multiple myeloma trials.
| Trial | Ph | N | Regimen | Dose schedule/MTD | ORR % | DCR % (⩽SD) | Neutropenia⩾grade 3 | PFS; OS (months) |
|---|---|---|---|---|---|---|---|---|
| Schey et al.4 | I | 24 | Pom | MTD=2 mg per day | 54 | >90 | 58% (patients taking > 2mg 100%) | 9.7; 22.5 |
| Streetly et al.5 | I | 20 | Pom ± Dex | MTD=5 mg on alternate days | 50 | 90 | 45% | 10.5; 33 |
| Richardson et al.8 | I | 38 | Pom ± Dex | MTD=4 mg | 21 | NA | 53% (patients taking > 2mg 60%) | 4.6; 18.3 |
| Lacy et al.6 | II | 60 | Pom/Dex | 2 mg (28/28)+DXM | 63 | 88 | 31% | 11.6; 76% at 2 years |
| Leleu et al.13 | II | |||||||
| Arm A | 43 | Pom/Dex | 4 mg (21/28)+DXM | 30 | 79 | 65% | NA | |
| Arm B | 40 | Pom/Dex | 4 mg (28/28)+DXM | 47 | 85 | 58% | NA | |
| Lacy et al.7 | II | |||||||
| Cohort A | 35 | Pom/Dex | 2 mg (28/28)+DXM | 49 | 82 | 51% | 6.5; 78% at 6 months | |
| Cohort B | 35 | Pom/Dex | 4 mg (28/28)+DXM | 43 | 74 | 66% | 3.2; 67% at 6 months | |
| San Miguel MM-0031 | III | |||||||
| Cohort A | 302 | Pom/Dex | 4 mg (21/28)+DXM | 21 | 82 | 48% | 4.0; 12.7 | |
| Cohort B | 153 | Dex | DXM | 3 | 62 | 16% | 1.9; 8.1 | |
| Sehgal et al.9 | II | |||||||
| Cohort 1 | 19 | Pom/Dex | 2mg (28/28) | 21 | NA | 42% | 4.3; 21.7 | |
| Cohort 2 | 20 | Pom/Dex | 4mg (21/28) | 45 | NA | 45% | 5.1; 17.7 |
Abbreviations: DCR, disease control rate; DXM, dexamethasone; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; SD, stable disease.