Table 1. Efficacy and safety of regimens used as frontline treatment for newly diagnosed, transplantation-ineligible patients with multiple myeloma: phase III studies.
| Study/reference | Induction regimen | n | Maintenance regimen | CR, % | VGPR, % | ORR, % | PFS, months | Median OS, % |
|---|---|---|---|---|---|---|---|---|
| GIMEMA/Palumbo et al.12, 13 | MPT | 129 | T until progression | 15.5 | 29.3 | 76.0 | 21.8* | 45.0 |
| MP | 126 | None | 2.4 | 11.0 | 47.6 | 14.5 | 47.6 | |
| IFM099-06/Facon et al.8 | MPT | 125 | None | 13 | 47 | 76 | 27.5* | 51.6* |
| MP | 196 | None | 2 | 7 | 35 | 17.8 | 33.2 | |
| IFM01-01/Hulin et al.9 | MPT | 113 | None | 7 | 21 | 62 | 24.1* | 44.0* |
| MP | 116 | None | 1 | 7 | 31 | 18.5 | 29.1 | |
| HOVON-49/Wijermans et al.14 | MPT | 164 | T until relapse | 23 (CR+VGPR) | 66 | EFS: 13* | 40* | |
| MP | 167 | 8 (CR+VGPR) | 45 | EFS: 9 | 31 | |||
| Beksac et al.15 | MPT | 60 | None | — | 59.2 | — | — | — |
| MP | 62 | None | — | 3.8 | — | — | — | |
| NMSG 12/Waage et al.10 | MPT | 182 | T until progression | 13 | 10 | 57 | 15 | 29 |
| MP | 175 | None | 4 | 3 | 40 | 14 | 32 | |
| Ludwig et al.16 | TD | NS | Patients randomized to IFN or IFN-T | 2 | 24 | 68 | 16.7 | 41.5* |
| MP | NS | 2 | 11 | 50 | 20.7 | 49.4 | ||
| Morgan et al.17 | CTDa | 426 | T or no maintenance until progression | 13.1 | 16.9 | 63.8 | 13.0* | 33.2 |
| MP | 423 | 2.4 | 1.7 | 32.6 | 12.4 | 30.6 | ||
| VISTA/San Miguel et al.18 3-year follow-up data/Mateos et al.19 | MPV | 344 | None | 33 | 8 | 71 | — | Not reached* |
| MP | 338 | None | 4 | 4 | 35 | — | 43.1 after 3-years | |
| PETHEMA/GEM/Mateos et al.20 | VMP | 130 | Randomized to VT or VP | 20 | 12 | 80 | — | — |
| VTP | 130 | 28 | 8 | 81 | — | — | ||
| GIMEMA MM-03-05/Palumbo et al.21 | VMPT | 254 | VT | 38 | — | — | 3-year: 55%* | — |
| VMP | 257 | None | 24 | — | — | 3-year: 38% | — | |
| SWOG S0232/Zonder et al.22 | RD | 97 | None | — | 63 | 78 | 1-year: 78%* | 1-year: 94% |
| Dexamethasone | 95 | None | — | 16 | 48 | 1-year: 48% | 1-year: 88% | |
| E4A03/Rajkumar et al.23 | RD | 223 | None | 5 | 33 | 81 | 19.1* | Not reached |
| Rd | 222 | None | 4 | 26 | 70 | 25.3 | Not reached | |
| MM-015/Palumbo et al.24 | MPR–R | 152 | R until progression | 10 | 23 | 77 | 31* | Not reached |
| MPR | 153 | Placebo until progression | 3 | 29 | 68 | 14 | Not reached | |
| MP | 154 | Placebo until progression | 3 | 9 | 50 | 13 | Not reached |
Abbreviations: CR, complete response; CTDa, cyclophosphamide, thalidomide and attenuated dexamethasone; EFS, event-free survival; IFN, interferon; MP, melphalan plus prednisone; MPR, MP and lenalidomide; MPR–R, MPR plus melphalan maintenance; MPT, MP plus thalidomide; MPV, MP plus bortezomib; NS, not specified; ORR, overall response rate (at least partial response); OS, overall survival; PFS, progression-free survival; PN, peripheral neuropathy; Rd, lenalidomide plus low-dose dexamethasone; RD, lenalidomide plus standard-dose dexamethasone; T, thalidomide; TD, thalidomide plus dexamethasone; VGPR, very good partial response; VMP, bortezomib plus MP; VMPT, VMP plus thalidomide; VTP, bortezomib, thalidomide and prednisone.
*P⩽0.05 vs control arm.