Ongoing phase 3 consolidation/maintenance studies incorporating novel agents
| Study . | Induction . | Consolidation s/p ASCT . | Maintenance . | Primary end point . |
|---|---|---|---|---|
| NCT02181413 | Not specified | None | Ixa vs placebo for 2 y | PFS |
| SWOG (planned) | Not specified | None | Len + Ixa vs Len until PD | OS |
| NCT02406144 | RVD ×6 (patients on GEM2012MENOS65 (NCT01916252), randomized to MEL200 vs BUMEL for ASCT high-dose therapy | RVD ×2 (patients on GEM2012MENOS65) | Len + Dex for 2 y or Len + Dex + Ixa for 2 y | PFS |
| At 2 y, MRD− stop maintenance, MRD+ continue Len + Dex for 3 y | ||||
| GMMG-HD6 | VRD ×4 | VRD ×2 | Len + Dex for 2 y | PFS |
| (NCT02495922) | VRD ×4 | VRD + Elo × 2 | Len + Dex + Elo for 2 y | |
| VRD + Elo × 4 | VRD×2 | Len + Dex for 2 y | ||
| VRD + Elo × 4 | VRD+ Elo × 2 | Len + Dex + Elo for 2 y | ||
| DSMM XIV (NCT01685814) | RAD ×3 vs VRD ×3 | If ≥VGPR after first ASCT, randomization to nothing vs second ASCT. | For single/tandem ASCT: Len for 3 y | Induction phase: CR rate |
| If <VGPR after first ASCT, randomization to second ASCT vs AlloSCT | For AlloSCT: Len for 1 y | Consolidation phase: PFS | ||
| FORTE | KCd ×4 then ASCT | KCd ×4 | All arms randomized to Len vs Len + Car | ≥VGPR rate after induction |
| (NCT02203643) | KRd ×4 then ASCT | KCd ×4 | ||
| KCd ×4, stem collection, then KRd ×8 | ||||
| MRC Myeloma XI + (NCT01554852) | CRD vs CTD vs KRCD | None | Len vs Len + Vorinostat vs Observation | Induction: PFS/OS |
| VCD consolidation prior to ASCT for <VGPR | Maintenance: PFS/OS | |||
| HOVON 131 MM/IFM 2015-01 | VTD ×4 | VTD ×2 | Both arms randomized to Dara vs observation | sCR rate after consolidation |
| (NCT02541383) | VTD-Dara ×4 | VTD-Dara ×2 | Maintenance: PFS/TTP |
| Study . | Induction . | Consolidation s/p ASCT . | Maintenance . | Primary end point . |
|---|---|---|---|---|
| NCT02181413 | Not specified | None | Ixa vs placebo for 2 y | PFS |
| SWOG (planned) | Not specified | None | Len + Ixa vs Len until PD | OS |
| NCT02406144 | RVD ×6 (patients on GEM2012MENOS65 (NCT01916252), randomized to MEL200 vs BUMEL for ASCT high-dose therapy | RVD ×2 (patients on GEM2012MENOS65) | Len + Dex for 2 y or Len + Dex + Ixa for 2 y | PFS |
| At 2 y, MRD− stop maintenance, MRD+ continue Len + Dex for 3 y | ||||
| GMMG-HD6 | VRD ×4 | VRD ×2 | Len + Dex for 2 y | PFS |
| (NCT02495922) | VRD ×4 | VRD + Elo × 2 | Len + Dex + Elo for 2 y | |
| VRD + Elo × 4 | VRD×2 | Len + Dex for 2 y | ||
| VRD + Elo × 4 | VRD+ Elo × 2 | Len + Dex + Elo for 2 y | ||
| DSMM XIV (NCT01685814) | RAD ×3 vs VRD ×3 | If ≥VGPR after first ASCT, randomization to nothing vs second ASCT. | For single/tandem ASCT: Len for 3 y | Induction phase: CR rate |
| If <VGPR after first ASCT, randomization to second ASCT vs AlloSCT | For AlloSCT: Len for 1 y | Consolidation phase: PFS | ||
| FORTE | KCd ×4 then ASCT | KCd ×4 | All arms randomized to Len vs Len + Car | ≥VGPR rate after induction |
| (NCT02203643) | KRd ×4 then ASCT | KCd ×4 | ||
| KCd ×4, stem collection, then KRd ×8 | ||||
| MRC Myeloma XI + (NCT01554852) | CRD vs CTD vs KRCD | None | Len vs Len + Vorinostat vs Observation | Induction: PFS/OS |
| VCD consolidation prior to ASCT for <VGPR | Maintenance: PFS/OS | |||
| HOVON 131 MM/IFM 2015-01 | VTD ×4 | VTD ×2 | Both arms randomized to Dara vs observation | sCR rate after consolidation |
| (NCT02541383) | VTD-Dara ×4 | VTD-Dara ×2 | Maintenance: PFS/TTP |
BUMEL, busulfan-melphalan; Car, carfilzomib; CRD, Cyclophosphamide, lenalidomide, dexamethasone; CTD, cyclophosphamide, thalidomide, dexamethasone; Dara, daratumumab; Elo, elotuzumab; Ixa, ixazomib; KCd, carfilzomib, cyclophosphamide, dexamethasone; KRCD, carfilzomib, lenalidomide, cyclophosphamide, dexamethasone; KRd, carfilzomib, lenalidomide, dexamethasone; RAD, lenalidomide, adriamycin, dexamethasone; sCR, stringent CR; VRD, bortezomib, lenalidomide, dexamethasone (RVD). Other abbreviations are explained in Tables 1, 3, and 4.