CD38 antibodies plus pomalidomide-dexamethasone in relapsed/refractory MM
| . | NCT0199897166 . | NCT0228377567,106 . | NCT0142118636,65 . |
|---|---|---|---|
| Phase | 1b | 1b | 1/2a |
| Regimen | Daratumumab-pom/dex | Isatuximab-pom/dex | MOR202-pom/dex |
| Treatments | Daratumumab (16 mg/kg): weekly for 8 wk, then Q2W for 16 wk, thereafter Q4W | Isatuximab 5, 10, or 20 mg/kg, weekly during first cycle, then every 2 wk | MOR202 8-16 mg/kg, weekly |
| Pomalidomide: 4 mg on days 1-21 per 28-d cycle | Pomalidomide: 4 mg on days 1-21/28 d cycle | Pomalidomide: 4 mg on days 1-21 per 28-d cycle | |
| Dexamethasone: 40 mg weekly (20 mg if age >75 y) | Dexamethasone: 40 mg weekly (20 mg if age ≥75 y) | Dexamethasone: 40 mg weekly (20 mg if age >75 y) | |
| Treatment until progression | Treatment until progression | Treatment until progression or a maximum of 2 y | |
| No. of patients | 103 | 20 (14 evaluable patients) | 11 (9 evaluable for response) |
| Median age, y | 64 | 65.5 | 66 |
| Median no. of prior therapies | 4 | 5.0 | 3 |
| Len-refractory, % | 89 | 75 | 100 |
| Bort-refractory, % | 71 | 45 | 36 |
| IRR, % | 50 (mostly grade ≤ 2) | 45 (all grade 1 or 2) | 0 |
| ≥PR | 60.2 | 64.3 | 55.6 |
| ≥VGPR | 41.7 | 35.7 | 22.2 |
| ≥CR | 16.5 | 7.1 | 22.2 |
| MRD− disease (10−5) among patients with CR or better, % | 29.4 | NA | NA |
| Median PFS, mo | 8.8 | Not reported | Not reached |
| Median OS, mo | 17.5 | Not reported | Not reached |
| . | NCT0199897166 . | NCT0228377567,106 . | NCT0142118636,65 . |
|---|---|---|---|
| Phase | 1b | 1b | 1/2a |
| Regimen | Daratumumab-pom/dex | Isatuximab-pom/dex | MOR202-pom/dex |
| Treatments | Daratumumab (16 mg/kg): weekly for 8 wk, then Q2W for 16 wk, thereafter Q4W | Isatuximab 5, 10, or 20 mg/kg, weekly during first cycle, then every 2 wk | MOR202 8-16 mg/kg, weekly |
| Pomalidomide: 4 mg on days 1-21 per 28-d cycle | Pomalidomide: 4 mg on days 1-21/28 d cycle | Pomalidomide: 4 mg on days 1-21 per 28-d cycle | |
| Dexamethasone: 40 mg weekly (20 mg if age >75 y) | Dexamethasone: 40 mg weekly (20 mg if age ≥75 y) | Dexamethasone: 40 mg weekly (20 mg if age >75 y) | |
| Treatment until progression | Treatment until progression | Treatment until progression or a maximum of 2 y | |
| No. of patients | 103 | 20 (14 evaluable patients) | 11 (9 evaluable for response) |
| Median age, y | 64 | 65.5 | 66 |
| Median no. of prior therapies | 4 | 5.0 | 3 |
| Len-refractory, % | 89 | 75 | 100 |
| Bort-refractory, % | 71 | 45 | 36 |
| IRR, % | 50 (mostly grade ≤ 2) | 45 (all grade 1 or 2) | 0 |
| ≥PR | 60.2 | 64.3 | 55.6 |
| ≥VGPR | 41.7 | 35.7 | 22.2 |
| ≥CR | 16.5 | 7.1 | 22.2 |
| MRD− disease (10−5) among patients with CR or better, % | 29.4 | NA | NA |
| Median PFS, mo | 8.8 | Not reported | Not reached |
| Median OS, mo | 17.5 | Not reported | Not reached |
dex, dexamethasone; pom, pomalidomide. Other abbreviations are explained in Table 1.