Pivotal randomized phase 3 trials of monoclonal antibody treatment for MM
| Clinical trial . | Patient population . | Arm (n = number of patients) . | Overall response (%) . | Median progression-free survival (months) . | Hazard ratio (P value) . |
|---|---|---|---|---|---|
| ALCYONE12 | Transplant-ineligible NDMM | D-VMP (n = 350) | 91 | 36.4 | 0.42 (P < .001) |
| VMP (n = 356) | 74 | 19.3 | |||
| MAIA11 | Transplant-ineligible NDMM | D-Rd (n = 368) | 92.9 | NR | 0.53 (P < .001) |
| Rd (n = 369) | 81.6 | 34.4 | |||
| ELOQUENT 124 | Transplant-ineligible NDMM | E-Rd (n = 374) | 83 | 31.4 | 0.93 (P = .44) |
| Rd (n = 374) | 79 | 29.5 | |||
| CASSIOPEIA9 | Transplant-eligible NDMM | D-VTd (n = 543) | 93 | NR | 0.47 (P < .001) |
| VTd (n = 542) | 90 | NR | |||
| GRIFFIN10,a | Transplant-eligible NDMM | D-RVd (n = 99) | 99 | NR | Not available |
| RVd (n = 97) | 92 | NR | |||
| GMMG-HD623 | Transplant-eligible NDMM | E-RVd (n = 555) | B1 81.5%; B2 80.7% (≥VGPR) | B1 66.2%; B2 67.2% (3 y PFS) | Not available (P = .86; no significant difference) |
| RVd (n = 559) | A1 78.9%; A2 78.2% (≥VGPR) | A1 68.8%; A2 68.5% (3 y PFS) | |||
| GMMG-HD719 | Transplant-eligible NDMM | I-RVd (n = 329) | MRD 50.1% | NR | Not available (OR = 1.82; P < .001) |
| RVd (n = 331) | MRD 35.6% | NR | |||
| POLLUX6 | RRMM, at least 1 prior line | D-Rd (n = 286) | 93 | 44.5 | 0.44 (P < .001) |
| Rd (n = 283) | 76 | 17.5 | |||
| ELOQUENT 220 | RRMM, 1-3 prior lines | E-Rd (n = 321) | 79 | 19.4 | 0.71 (P < .001) |
| Rd (n = 325) | 66 | 14.9 | |||
| CANDOR8 | RRMM, 1-3 prior lines | D-Kd (n = 312) | 84 | NR | 0.62 (P = .003) |
| Kd (n = 154) | 75 | 15.8 | |||
| IKEMA18 | RRMM, 1-3 prior lines | I-Kd (n = 179) | 87 | NR | 0.53 (P < .001) |
| Kd (n = 123) | 83 | 19.2 | |||
| CASTOR5 | RRMM, at least 1 prior line | D-Vd (n = 251) | 83 | 16.7 | 0.31 (P < .001) |
| Vd (n = 247) | 63 | 7.1 | |||
| ELOQUENT 321 | RRMM, at least 2 prior lines | E-Pd (n = 60) | 53 | 10.3 | 0.54 (P = .008) |
| Pd (n = 57) | 26 | 4.7 | |||
| APOLLO7 | RRMM, at least 1 prior line | D-Pd (n = 151) | 69 | 12.4 | 0.63 (P = .0018) |
| Pd (n = 153) | 46 | 6.9 | |||
| ICARIA-MM17 | RRMM, at least 2 prior lines | I-Pd (n = 154) | 63 | 11.5 | 0.6 (P = .001) |
| Pd (n = 153) | 32 | 6.5 |
| Clinical trial . | Patient population . | Arm (n = number of patients) . | Overall response (%) . | Median progression-free survival (months) . | Hazard ratio (P value) . |
|---|---|---|---|---|---|
| ALCYONE12 | Transplant-ineligible NDMM | D-VMP (n = 350) | 91 | 36.4 | 0.42 (P < .001) |
| VMP (n = 356) | 74 | 19.3 | |||
| MAIA11 | Transplant-ineligible NDMM | D-Rd (n = 368) | 92.9 | NR | 0.53 (P < .001) |
| Rd (n = 369) | 81.6 | 34.4 | |||
| ELOQUENT 124 | Transplant-ineligible NDMM | E-Rd (n = 374) | 83 | 31.4 | 0.93 (P = .44) |
| Rd (n = 374) | 79 | 29.5 | |||
| CASSIOPEIA9 | Transplant-eligible NDMM | D-VTd (n = 543) | 93 | NR | 0.47 (P < .001) |
| VTd (n = 542) | 90 | NR | |||
| GRIFFIN10,a | Transplant-eligible NDMM | D-RVd (n = 99) | 99 | NR | Not available |
| RVd (n = 97) | 92 | NR | |||
| GMMG-HD623 | Transplant-eligible NDMM | E-RVd (n = 555) | B1 81.5%; B2 80.7% (≥VGPR) | B1 66.2%; B2 67.2% (3 y PFS) | Not available (P = .86; no significant difference) |
| RVd (n = 559) | A1 78.9%; A2 78.2% (≥VGPR) | A1 68.8%; A2 68.5% (3 y PFS) | |||
| GMMG-HD719 | Transplant-eligible NDMM | I-RVd (n = 329) | MRD 50.1% | NR | Not available (OR = 1.82; P < .001) |
| RVd (n = 331) | MRD 35.6% | NR | |||
| POLLUX6 | RRMM, at least 1 prior line | D-Rd (n = 286) | 93 | 44.5 | 0.44 (P < .001) |
| Rd (n = 283) | 76 | 17.5 | |||
| ELOQUENT 220 | RRMM, 1-3 prior lines | E-Rd (n = 321) | 79 | 19.4 | 0.71 (P < .001) |
| Rd (n = 325) | 66 | 14.9 | |||
| CANDOR8 | RRMM, 1-3 prior lines | D-Kd (n = 312) | 84 | NR | 0.62 (P = .003) |
| Kd (n = 154) | 75 | 15.8 | |||
| IKEMA18 | RRMM, 1-3 prior lines | I-Kd (n = 179) | 87 | NR | 0.53 (P < .001) |
| Kd (n = 123) | 83 | 19.2 | |||
| CASTOR5 | RRMM, at least 1 prior line | D-Vd (n = 251) | 83 | 16.7 | 0.31 (P < .001) |
| Vd (n = 247) | 63 | 7.1 | |||
| ELOQUENT 321 | RRMM, at least 2 prior lines | E-Pd (n = 60) | 53 | 10.3 | 0.54 (P = .008) |
| Pd (n = 57) | 26 | 4.7 | |||
| APOLLO7 | RRMM, at least 1 prior line | D-Pd (n = 151) | 69 | 12.4 | 0.63 (P = .0018) |
| Pd (n = 153) | 46 | 6.9 | |||
| ICARIA-MM17 | RRMM, at least 2 prior lines | I-Pd (n = 154) | 63 | 11.5 | 0.6 (P = .001) |
| Pd (n = 153) | 32 | 6.5 |
Randomized phase 2 study
Note: This list is not exhaustive for all randomized trials including monoclonal antibodies.
D, daratumumab; d, dexamethasone; E, elotuzumab; I, isatuximab; K, carfilzomib; M, melphalan; OR, odds ratio; P, pomalidomide; p, prednisone; R, lenalidomide; T, thalidomide; V, bortezomib.