Table 5 Summary of phase III clinical trials evaluating the efficacy of tandem ASCT to ASCT-RIC-Allo-SCT in the upfront setting for patients with MM
Clinical trial | No. | Randomized groups | ORR | EFS/PFS | OS | TRM |
---|---|---|---|---|---|---|
Krishnan et al. [130]. NDMM pts ≤70 y/o | 710 | ASCT × 2 | CR: 45% | 3-year PFS: 46% | 3-year OS: 80% | 3-year TRM: 4% |
ASCT→RIC-Allo-SCT (TBI 2 Gy) | CR: 58% | 3-year PFS: 43% | 3-year OS: 77% | 3-year TRM: 11% | ||
Giaconne et al. [129]. NDMM pts ≤65 y/o | 162 | ASCT × 2 | CR: 26% | Median EFS: 2.4 years | Median OS: 4.25 years | 2-year TRM: 2% |
ASCT→RIC-Allo-SCT (TBI 2 Gy) | CR: 55% | Median EFS: 2.8 years | Median OS: NR | 2-year TRM:10% | ||
Gahrton et al. [127]. NDMM pts <70 y/o | 357 | ASCT × 2 | CR: 41% | 8-year PFS:12% | 8-year OS: 36% | 3-year TRM: 3% |
ASCT→RIC-Allo-SCT (Flu/TBI 2 Gy) | CR: 50% | 8-year PFS: 22% | 8-year OS: 49% | 3-year TRM: 13% | ||
Moreau et al. [128]. NDMM pts <65 y/o (w/ del 13 and β2-microglobulin >3 mg/l) | 284 | ASCT × 2 (+/− anti-IL6 antibody) | CR: 38% | Median EFS: 22 mos | Median OS: 48 mos | 5-year TRM: N/A |
ASCT→RIC-Allo-SCT (Flu/Bu) | CR: 62% | Median EFS: 19 mos | Median OS: 34 mos | 5-year TRM: 11% | ||
Rosinol et al. [126]. NDMM pts <70 y/o | 752 | ASCT × 2 | CR: 11% | Median PFS: 31 mos | Median OS: 58 mos | TRM: 5% |
ASCT→RIC-Allo-SCT (Flu/Mel) | CR: 40% | Median PFS: NR | Median OS: NR | TRM: 16% | ||
Knop et al. [125]. NDMM pts ≤60 y/o (w/ del 13) | 199 | ASCT × 2 | CR: 31% | Median PFS: 23 mos | Median OS: 72 mos | 2-year TRM: 4% |
ASCT→RIC-Allo-SCT (Flu/Mel) | CR: 59% | Median PFS: 35 mos | Median OS: 70 mos | 2-year TRM: 12% |