Table 3.
Summary of significant clinical trials evaluating the efficacy of monoclonal antibodies in multiple myeloma.
| Agents | Study details | Patients | Regimens | Outcomes | Adverse events | Refs. |
|---|---|---|---|---|---|---|
| CD38 monoclonal antibodies |
POLLUX Phase III |
R/RMM at least 1 prior line n = 569 |
Daratumumab+ Rd vs. Rd | ORR: 92.9% vs. 76.4%; median PFS: 44.5 vs. 17.5 months | Common ≥grade 3 AEs: neutropenia (55.5% vs. 41.6%), anemia (17.7% vs. 21.4%) | [54] |
|
CASTOR Phase III |
R/RMM at least 1 prior line n = 498 |
Daratumumab+ Vd vs. Vd | ORR: 83.8% vs. 63.2%; median PFS: 16.7 vs. 7.1 months | Common ≥grade 3 AEs: thrombocytopenia (45.7% vs. 32.9%), anemia (15.2% vs. 16.0%) | [58] | |
|
CANDOR Phase III |
R/RMM at least 1 prior line n = 466 |
Daratumumab+ Kd vs. Kd | ORR: 84.3% vs. 74.7%; median PFS: 28.6 vs. 15.2 months | Common ≥grade 3 AEs: thrombocytopenia (25% vs. 16%), hypertension (21% vs. 15%) | [61] | |
|
GRIFFIN Phase II |
NDMM transplant eligible n = 207 |
Daratumumab+ VRd vs. VRd | ORR: 99.0% vs. 91.8%; 1-year PFS: 95.8% vs. 89.8% | Common ≥grade 3 AEs: neutropenia (41.4% vs. 21.6%), lymphopenia (23.2% vs. 21.6%) | [64] | |
|
CASSIOPEIA Phase III |
NDMM transplant eligible n = 1085 |
Daratumumab+ VTd vs. VTd | ORR: 92.6% vs. 89.9%; 18-month PFS: 93% vs. 85% | Common ≥grade 3 AEs: neutropenia (28% vs. 15%), lymphopenia (17% vs. 10%) | [65] | |
|
ALCYONE Phase III |
NDMM transplant ineligible n = 706 |
Daratumumab+ VMP vs. VMP |
ORR: 91% vs. 74%; 18-month PFS: 72% vs. 50%. |
Common ≥grade 3 AEs: neutropenia (39.9% vs.38.7%), thrombocytopenia (34.4% vs. 37.6%) | [68] | |
|
MAIA Phase III |
NDMM transplant ineligible n = 737 |
Daratumumab+ Rd vs. Rd |
ORR: 93% vs. 81%; median PFS: not reached vs. 34.4 months |
Common ≥grade 3 AEs: neutropenia (54% vs. 37%), pneumonia (19% vs. 11%) | [69] | |
|
ICARIA Phase III |
R/RMM at least 2 prior lines n = 307 |
Isatuximab +Pd vs. Pd |
ORR: 60% vs. 35%; median PFS: 11.5 vs. 6.5 months |
Common any-grade AEs: infusion reactions (38% vs. 0%), pneumonia (20% vs. 17%) | [80] | |
|
IKEMA Phase III |
R/RMM at least 1 prior lines n = 302 |
Isatuximab +Kd vs. Kd |
ORR: 87% vs. 83%; median PFS: not reached vs. 19.15 months |
Common ≥grade 3 AEs: respiratory infection (32% vs. 24%), thrombocytopenia (30% vs. 24%) | [86] | |
|
GMMG-CONCEPT Phase II |
NDMM High-risk n = 50 |
Isatuximab+KRd | ORR: 100%; 24-month PFS: 75.5% | Common ≥grade 3 AEs: infectious (10%), cardiovascular disorders (10%) | [88] | |
| SLAMF7 monoclonal antibodes |
ELOQUENT-2 Phase III |
R/RMM at least 1 prior lines n = 646 |
Elotuzumab+ Rd vs. Rd |
ORR: 79% vs. 66%; median PFS: 19.4 vs. 14.9 months |
Common ≥grade 3 AEs: infections (35% vs. 27%), neutropenia (27% vs. 34%) | [90, 91] |
|
ELOQUENT-3 Phase II |
R/RMM at least 2 prior lines n = 117 |
Elotuzumab+ Pd vs. Pd |
ORR: 53% vs. 26%; median PFS: 10.3 vs. 4.7 months |
Common ≥grade 3 AEs: neutropenia (13% vs. 27%), anemia (10% vs.20%) | [92] | |
|
SWOG S1211 Phase II |
NDMM High-risk n = 100 |
Elotuzumab+ VRd vs. VRd |
ORR: 83% vs. 88%; median PFS: 31.47 vs. 33.64 months |
Common ≥grade 3 AEs: infections (17% vs. 8%), sensory neuropathy (13% vs. 8%) | [95] |
R/RMM relapsed/refractory multiple myeloma, ORR overall response rate, PFS progression-free survival, AEs adverse events, Rd lenalidomide + dexamethasone, Vd bortezomib + dexamethasone, Kd carfilzomib + dexamethasone, VRd bortezomib + lenalidomide + dexamethasone, VTd bortezomib + thalidomide + dexamethasone, VMP bortezomib + melphalan + and prednisone, Pd pomalidomide+ dexamethasone.