Phase 3 trials incorporating novel agent–based induction prior to ASCT
| Study by induction regimen . | Treatment schema . | No. . | Postinduction (%) . | Posttransplant (%) . | Long-term outcomes (%) . | ||
|---|---|---|---|---|---|---|---|
| ORR . | CR VGPR . | ORR . | CR VGPR . | ||||
| IFM 2005-0112 | |||||||
| VAD | VADx4 ± DCEPx2-ASCT Mel200 | 242 | 63 | 1 | 77 | 9 | Median PFS: 30 mo |
| vs | 15 | 37 | |||||
| VD | VDx4 ± DCEPx2- ASCT Mel200 | 240 | 78 | 6 | 80 | 16 | Median PFS: 36 mo |
| GIMEMA MM-BO200514 | 38 | 54 | |||||
| VTD | VTDx3-ASCT Mel200x2-VTDx2-Dm | 236 | 93 | 19 CR | 93 | 42 CR | 3-y PFS: 68 |
| vs | 62 ≥ VGPR | 82 ≥ VGPR | 3-y OS: 86 | ||||
| TD | TDx3-ASCT Mel200x2-TDx2-Dm | 238 | 79 | 5 CR | 84 | 30 CR | 3-y PFS: 56 |
| PETHEMA GEM05MENOS6516 | 28 ≥ VGPR | 64 ≥ VGPR | 3-y OS: 84 | ||||
| TD | TDx6-ASCT Mel200-IFNm/Tm/VTm × 3 y | 127 | 62 | 14 CR | NR | 40 CR | Median PFS: 28 mo |
| vs | 29 ≥ VGPR | 4-y OS: 65% | |||||
| VTD | VTDx6-ASCT Mel200-IFNm/Tm/VTm × 3 y | 130 | 85 | 35 CR | NR | 57 CR | Median PFS: 56 mo |
| vs | 60 ≥ VGPR | 4-y OS: 74% | |||||
| VBMCP/VBAD/Vel | VBMCP/VBADx4-Vx2-ASCT Mel200-IFNm/Tm/VTm × 3 y | 129 | 75 | 21 CR | NR | 48 CR | Median PFS: 35 mo |
| IFM 2007-0215 | 36 ≥ VGPR | 4-y OS: 70% | |||||
| VD | VDx4-ASCT Mel200 | 99 | 81 | 12 CR | 86 | 31 CR | Median PFS: 30 mo |
| vs | 36 ≥ VGPR | 58 ≥ VGPR | |||||
| VTD | VTDx4-ASCT Mel200 | 100 | 88 | 13 CR | 89 | 29 CR | Median PFS: 26 mo |
| HOVON-65/GMMG-HD422 | 49 ≥ VGPR | 74 ≥ VGPR | |||||
| VAD | VADx3-CAD-ASCT Mel200-Tm × 2 y | 414 | 54 | 2 CR | 75 | 9 CR | Median PFS: 28 mo |
| vs | 14 ≥ VGPR | 36 ≥ VGPR | 5-y OS: 55% | ||||
| PAD | PADx3-CAD-ASCT Mel200-Vm × 2 y | 413 | 78 | 7 CR | 88 | 21 CR | Median PFS: 35 mo |
| 42 ≥ VGPR | 62 ≥ VGPR | 5-y OS: 61% | |||||
| Study by induction regimen . | Treatment schema . | No. . | Postinduction (%) . | Posttransplant (%) . | Long-term outcomes (%) . | ||
|---|---|---|---|---|---|---|---|
| ORR . | CR VGPR . | ORR . | CR VGPR . | ||||
| IFM 2005-0112 | |||||||
| VAD | VADx4 ± DCEPx2-ASCT Mel200 | 242 | 63 | 1 | 77 | 9 | Median PFS: 30 mo |
| vs | 15 | 37 | |||||
| VD | VDx4 ± DCEPx2- ASCT Mel200 | 240 | 78 | 6 | 80 | 16 | Median PFS: 36 mo |
| GIMEMA MM-BO200514 | 38 | 54 | |||||
| VTD | VTDx3-ASCT Mel200x2-VTDx2-Dm | 236 | 93 | 19 CR | 93 | 42 CR | 3-y PFS: 68 |
| vs | 62 ≥ VGPR | 82 ≥ VGPR | 3-y OS: 86 | ||||
| TD | TDx3-ASCT Mel200x2-TDx2-Dm | 238 | 79 | 5 CR | 84 | 30 CR | 3-y PFS: 56 |
| PETHEMA GEM05MENOS6516 | 28 ≥ VGPR | 64 ≥ VGPR | 3-y OS: 84 | ||||
| TD | TDx6-ASCT Mel200-IFNm/Tm/VTm × 3 y | 127 | 62 | 14 CR | NR | 40 CR | Median PFS: 28 mo |
| vs | 29 ≥ VGPR | 4-y OS: 65% | |||||
| VTD | VTDx6-ASCT Mel200-IFNm/Tm/VTm × 3 y | 130 | 85 | 35 CR | NR | 57 CR | Median PFS: 56 mo |
| vs | 60 ≥ VGPR | 4-y OS: 74% | |||||
| VBMCP/VBAD/Vel | VBMCP/VBADx4-Vx2-ASCT Mel200-IFNm/Tm/VTm × 3 y | 129 | 75 | 21 CR | NR | 48 CR | Median PFS: 35 mo |
| IFM 2007-0215 | 36 ≥ VGPR | 4-y OS: 70% | |||||
| VD | VDx4-ASCT Mel200 | 99 | 81 | 12 CR | 86 | 31 CR | Median PFS: 30 mo |
| vs | 36 ≥ VGPR | 58 ≥ VGPR | |||||
| VTD | VTDx4-ASCT Mel200 | 100 | 88 | 13 CR | 89 | 29 CR | Median PFS: 26 mo |
| HOVON-65/GMMG-HD422 | 49 ≥ VGPR | 74 ≥ VGPR | |||||
| VAD | VADx3-CAD-ASCT Mel200-Tm × 2 y | 414 | 54 | 2 CR | 75 | 9 CR | Median PFS: 28 mo |
| vs | 14 ≥ VGPR | 36 ≥ VGPR | 5-y OS: 55% | ||||
| PAD | PADx3-CAD-ASCT Mel200-Vm × 2 y | 413 | 78 | 7 CR | 88 | 21 CR | Median PFS: 35 mo |
| 42 ≥ VGPR | 62 ≥ VGPR | 5-y OS: 61% | |||||
CAD, cyclophosphamide-doxorubicin-dexamethasone; DCEP, dexamethasone-cyclophosphamide-etoposide-cisplatin; Dm, dexamethasone maintenance; GIMEMA, Gruppo Italiano Malattie Ematologiche dell’Adulto; HOVON, Dutch-Belgian Hemato-Oncology Group; IFM, Intergroupe Francophone du Myélome; IFNm, interferon maintenance; NR, not reported; ORR, overall response rate; PAD, bortezomib-doxorubicin-dexamethasone; PETHEMA/GEM, Programa para el Estudio y la Terapéutica de las Hemopatías Malignas/Grupo Español de Mieloma; PR, partial response; TD, thalidomide-dexamethasone; Tm, thalidomide maintenance; V, bortezomib; VBAD, vincristine-BCNU-doxorubicin-dexamethasone; VBMCP, vincristine-BCNU-melphalan-cyclophosphamide-prednisone; Vm, bortezomib maintenance; VTD, bortezomib-thalidomide-dexamethasone; VTm, bortezomib-thalidomide maintenance.