Table 3.
Summary of select data from randomized trials for induction therapy for transplant-eligible NDMM
| Reference | Patients: total/arms, No. | Median follow-up, mo | Median age, y | Regimen | PFS | OS |
|---|---|---|---|---|---|---|
| GIMEMA62 | 236 vs 238 | 43 | 57 | VTd vs Td | 3-y PFS 68% vs 56% | 3-y 86% vs 84% |
| IFM2013-0463 | 169 vs 169 | NR | 59.5 | VTd vs VCd | NR | NR |
| EMNO2/HO9523 | 495 vs 702 | 60.3 | 58 | VCd-ASCT vs VCd-VMP |
Median PFS 56.7 vs 41.9 mo (HR, 0.73, P = .0001) | 5-y OS 75.1% vs 71.6% (HR, 0.90; 95% CI 0.71-1.13; P = .35) |
| STAMINA24 |
247 vs 254 vs 257 | 38 | 56 | ASCT-R vs ASCT-VRd-R vs Tandem ASCT-R |
38-mo PFS rate: ASCT/ASCT-R: 58.5% (95% CI, 51.7%-64.6%) ASCT-VRd-R: 57.8% (95% CI, 51.4%-63.7%) ASCT-R: 53.9% (95% CI, 47.4%-60%) |
OS: ASCT+ R: 81.8% (95% CI, 76.2%-86.2%) ASCT-VRd-R: 85.4% (95% CI, 80.4%-89.3%) ASCT-R: 83.7% (95% CI, 78.4%-87.8%) |
| IFM 200925 |
350 vs 350 | 44 | 59.5 | RVd-ASCT-R RVd-R |
Median 50 vs 36 mo (HR, 0.65; 95% CI, 0.53-0.80; P < .001) |
4 y: 81% vs 82% (HR, 1.16; 95% CI, 0.80-1.68; P = .87) |
| DETERMINATION7 | 365 vs 357 | 76 | 56 | RVd-ASCT-R RVd-R |
Median: 67.5 vs 46.2 mo (HR, 1.53; 95% CI, 1.23-1.91; P < .001) | 5 y: 79% vs 81% (HR, 1.10; 95% CI, 0.73-1.65; P > .99) |
| FORTE8,9 | 158 vs 157 vs 159 | 50.9 | 57 | KRd-ASCT-KRd KRd12 KCd-ASCT-KCd |
3 y: 68.8% vs 68.5% vs 67.2% (P = .86) 4 y: 69% (KRd-ASCT) vs 56% (KRd12) vs 51% (KCd-ASCT) HR for KRd-ASCT vs KCd-ASCT, 0.54; 95% CI, 0.38-0.78; P = .0008 HR for KRd-ASCT vs KRd12, 0.61; 95% CI, 0.43-0.88; P = .0084 |
4 y: 86% (KRd-ASCT) vs 85% (KRd12) vs 76% (KCd-ASCT) |
| GRIFFIN12 | 104 vs 103 | 22.1 |
60 (27%> 65 y) | D-RVd-ASCT-DR RVd-ASCT-R |
3 y: 88.9% vs 81.2% (HR, 0.46; 95% CI, 0.21-1.01) | 3 y: 92.6% vs 92.2% (HR, 0.90; 95% CI, 0.32-2.57) |
| CASSIOPEIA11 | 543 vs 542 | 18.8 | 58.5 | R1: D-VTd-ASCT-D-VTd VTd-ASCT-VTd R2: D maint vs obs |
Median: NR in either arm (HR, 0.47; 95% CI, 0.33-0.67; P < .0001) | Median: NR in either arm (HR, 0.43; 95% CI, 0.23-0.80) |
| GMMG-HD652 |
139 vs 141 vs 137 vs 142 |
49.8 | 59 | RVd-ASCT-R RVd-ASCT-EloR Elo-RVd-ASCT-R Elo-RVd-ASCT-EloR |
3 y: 68.8% vs 68.5% vs 66.2% vs 67.2% (P = .86) | 3 y: 89.4% vs 89.1% vs 92.5% vs 89.7% (P = .43) |
ASCT, autologous stem cell transplant; D, daratumumab; DR, daratumumab, lenalidomide; Elo, elotuzumab; maint, maintenance; NR, not reported; obs, observation; R, lenalidomide; Td, thalidomide, dexamethasone; V, bortezomib; VCd, bortezomib, cyclophosphamide, dexamethasone; VMP, bortezomib, melphalan, prednisone; VTd, bortezomib, thalidomide, dexamethasone; VRd, bortezomib, lenalidomide, dexamethasone.