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. 2024 Jan 27;10:55. doi: 10.1038/s41420-024-01818-6

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

NCT02076009

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

NCT02136134

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

NCT03158688

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

NCT02874742

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

NCT02541383

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

NCT02195479

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

NCT02252172

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

NCT02990338

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

NCT03275285

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

NCT03104842

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

NCT01239797

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

NCT02654132

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

NCT01668719

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.