Table 1.
a. Efficacy | |||||||
Trial | N pts | Treatment | OR (%) | CR/VGPR (%) | MRD neg (%) |
mPFS
[95% CI] (Months) |
mOS
[95% CI] (Months) |
ALCYONE [38] | 706 | Dara-VMP | 90.9 | 43/71 | 28 | 36.4 | 78.0 |
vs. | vs. | vs. | vs. | vs. | vs. | ||
VMP | 73.9 | 25/50 | 7 | 19.3 | 67.9 | ||
MAIA [16,39] | 737 | Dara-Rd | 93 | 50/81 | 24.2 | NR | NR |
vs. | vs. | vs. | vs. | vs. | vs. | ||
Rd | 82 | 27/55 | 7.3 | 33.8 | NR | ||
HOVON 143 [28] | 46 | Dara-Ixa-dex | - | 9-month PFS rates: | 9-month OS rates: | ||
interm.-fit | 87 | 0/39 | 78 (55–90) | 100 | |||
vs. | vs. | vs. | vs. | vs. | |||
frail pts | 78 | 4/26 | 61 (38–77) | 83 (60–93) | |||
SWOG-1211 [40] | 103 | Elo-VRd | - | - | - | 31 | 68 |
vs. | vs. | vs. | |||||
VRd | 34 | NR | |||||
TCD13983 [41,42,43] | 44 | Isa-VRd | 100 | 41/52 | 30.8 | NR | - |
vs. | vs. | vs. | vs. | vs. | |||
Isa-VCd | 93.3 | 59 | 33.3 | NR | |||
b. Safety | |||||||
Trial | N pts | Treatment | Total Discontinuation (%) | Discontinuation due to AE (%) | Discontinuation due to Death (%) | Grade 3–4 Hematologic Toxicities: Neutropenia/Anemia (%) | Grade 3–4 Non-Hematologic Toxicities: Infections (%) |
ALCYONE [38] | 706 | Dara-VMP | - | 7 | 24 | 40/15 | 22 |
vs. | vs. | vs. | vs. | vs. | |||
VMP | 9 | 36 | 39/20 | 15 | |||
MAIA [16,39] | 737 | Dara-Rd | 39 | 9 | 23 | 51/14 | 36 |
vs. | vs. | vs. | vs. | vs. | vs. | ||
Rd | 64 | 18 | 28 | 35.3/21 | 27 | ||
HOVON 143 [28] | 46 | Dara-Ixa-dex | |||||
Interm.-fit | 30 | 4 | 0 | 8/- | 9 | ||
vs. | vs. | vs. | vs. | vs. | vs. | ||
frail pts | 39 | 0 | 13 | 17/- | 9 | ||
SWOG-1211 [40] | 103 | Elo-VRd | - | - | - | - | 16 |
vs. | vs. | ||||||
VRd | 8 | ||||||
TCD13983 [41,42,43] | 22 | Isa-VRd | 14 | 9 | 5 | 12.5% | 27 |
Abbreviations: NTE, transplant ineligible; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; CR, complete response; VGPR, very good partial response; MRD, minimal residual disease; neg, negativity; mPFS, median progression-free survival; mOS, median overall survival; NR, not reached, AE, adverse event; CI, confidence interval; Dara, daratumumab; V, bortezomib; M, melphalan; P, prednisone; R, lenalidomide; d, dexamethasone; Ixa, ixazomib; Elo, elotuzumab; Isa, isatuximab; C, cyclophosphamide; interm.-fit, intermediate fit; N, number; pts, patients.