Treatment schemata of selected clinical trials
| Trial . | Induction . | Transplant . | Consolidation/Other . | Maintenance . | ||
|---|---|---|---|---|---|---|
| IFM 2007-20028 | Randomization N = 199 | Arm A: VD × 4 | MEL 200 mg/m2 + ASCT | Physician discretion | Physician discretion | |
| Arm B: vTD × 4 | ||||||
| PETHEMA/GE Study9 | Randomization N = 386 | Arm A: VBMCP/VBAD/ × 4 and V × 2 | MEL 200 mg/m2 or MEL 100 mg/m2 × 2 + ASCT | None | Randomization #2 | Interferon × 3 |
| Arm B: TD ×6 | T × 3 years | |||||
| Arm C: VTD × 6 | VT × 3 years | |||||
| GIMEMA Study10 | Randomization N = 480 | Arm A: VTD × 3 | MEL 200 mg/m2 + ASCT × 2 | Arm A: VTD × 2 | D only until relapse/toxicity | |
| Arm B: TD × 3 | Arm B: TD × 2 | |||||
| Hovon-65/ GMMM-HD411 | Randomization N = 827 | Arm A: VAD × CAD | MEL 200 mg/m2 + ASCT × 2 (GMM) or MEL 200 mg/m2 + ASCT × 1 (HOVON) | None | Arm A: T × 2 years | |
| Arm B: PAD* × 3 + CAD | Arm B: V × 2 years | |||||
| (62 patients received RIC allo-SCT post-ASCT × 1 if HLA-identical sibling available) | ||||||
| Total Therapy 3A/B12 | No randomization N = 480 | VTD-PACE × 2 | MEL 200 mg/m2 + ASCT × 2 | VTD-PACE × 2 | VTD/TD × 3 years (TT3A study) VRD × 3 years (TT3B study) | |
| Total Therapy 413 | Randomization N = 345 | Standard arm: MVDT-PACE × 2 | Standard arm: MEL 200 mg/m2 + ASCT × 2 | Standard arm: VTD-PACE × 2 | VRD × 3 years | |
| “Lite” arm: MVTD-PACE × 1 | “Lite” arm: VTD-MEL 50 mg/m2 × 4 + ASCT × 2 | “Lite” arm: VTD-PACE × 1 | ||||
| Total Therapy 5 and 613 | No randomization N = 72 | MEL-10 VTD-PACE × 1 | Mel 20 mg/m2 × 4 VRD-PACE + ASCT#1 Intertherapy: MEL 5 mg/m2 × 4 VTD-PACE × 2 cycles MEL 20 mg/m2 × 4 VRD-PACE + ASCT#2 | None | VRD × 3 years | |
| MMR-V-Pl-20914 | 2 × 2 factorial Randomization N = 403 | Arms A-D: RD × 4 | Arms A-B: MEL 200 mg/m2 + ASCT × 2 | Arms A-B: no ASCT | Arms A, C: R until relapse | |
| Arms B-C: none | Arms B-C: MPR × 6 | Arms B, C: none | ||||
| CRD vs MEL 20015 | 2 × 2 factorial Randomization N = 389 | Arms A-D: RD × 4 | Arms A-B: no ASCT | Arms A-B: CRD × 6 | Arms A, C: RP until relapse | |
| Arms C-D: MEL 200 mg/m2 + ASCT × 2 | Arms C-D: none | Arms B, C: R until relapse | ||||
| Trial . | Induction . | Transplant . | Consolidation/Other . | Maintenance . | ||
|---|---|---|---|---|---|---|
| IFM 2007-20028 | Randomization N = 199 | Arm A: VD × 4 | MEL 200 mg/m2 + ASCT | Physician discretion | Physician discretion | |
| Arm B: vTD × 4 | ||||||
| PETHEMA/GE Study9 | Randomization N = 386 | Arm A: VBMCP/VBAD/ × 4 and V × 2 | MEL 200 mg/m2 or MEL 100 mg/m2 × 2 + ASCT | None | Randomization #2 | Interferon × 3 |
| Arm B: TD ×6 | T × 3 years | |||||
| Arm C: VTD × 6 | VT × 3 years | |||||
| GIMEMA Study10 | Randomization N = 480 | Arm A: VTD × 3 | MEL 200 mg/m2 + ASCT × 2 | Arm A: VTD × 2 | D only until relapse/toxicity | |
| Arm B: TD × 3 | Arm B: TD × 2 | |||||
| Hovon-65/ GMMM-HD411 | Randomization N = 827 | Arm A: VAD × CAD | MEL 200 mg/m2 + ASCT × 2 (GMM) or MEL 200 mg/m2 + ASCT × 1 (HOVON) | None | Arm A: T × 2 years | |
| Arm B: PAD* × 3 + CAD | Arm B: V × 2 years | |||||
| (62 patients received RIC allo-SCT post-ASCT × 1 if HLA-identical sibling available) | ||||||
| Total Therapy 3A/B12 | No randomization N = 480 | VTD-PACE × 2 | MEL 200 mg/m2 + ASCT × 2 | VTD-PACE × 2 | VTD/TD × 3 years (TT3A study) VRD × 3 years (TT3B study) | |
| Total Therapy 413 | Randomization N = 345 | Standard arm: MVDT-PACE × 2 | Standard arm: MEL 200 mg/m2 + ASCT × 2 | Standard arm: VTD-PACE × 2 | VRD × 3 years | |
| “Lite” arm: MVTD-PACE × 1 | “Lite” arm: VTD-MEL 50 mg/m2 × 4 + ASCT × 2 | “Lite” arm: VTD-PACE × 1 | ||||
| Total Therapy 5 and 613 | No randomization N = 72 | MEL-10 VTD-PACE × 1 | Mel 20 mg/m2 × 4 VRD-PACE + ASCT#1 Intertherapy: MEL 5 mg/m2 × 4 VTD-PACE × 2 cycles MEL 20 mg/m2 × 4 VRD-PACE + ASCT#2 | None | VRD × 3 years | |
| MMR-V-Pl-20914 | 2 × 2 factorial Randomization N = 403 | Arms A-D: RD × 4 | Arms A-B: MEL 200 mg/m2 + ASCT × 2 | Arms A-B: no ASCT | Arms A, C: R until relapse | |
| Arms B-C: none | Arms B-C: MPR × 6 | Arms B, C: none | ||||
| CRD vs MEL 20015 | 2 × 2 factorial Randomization N = 389 | Arms A-D: RD × 4 | Arms A-B: no ASCT | Arms A-B: CRD × 6 | Arms A, C: RP until relapse | |
| Arms C-D: MEL 200 mg/m2 + ASCT × 2 | Arms C-D: none | Arms B, C: R until relapse | ||||
TT4 is for newly diagnosed GEP-defined low risk MM. TT5 and TT6 employ the same treatment schedule. TT5 is for newly diagnosed GEM-defined high risk patients, while TT6 enrolls patient who had >1cycle of prior therapy, but no ASCT, regardless of GEP risk.
CRD, cyclophosphamide, lenalidomide and dexamethasone.
bortezomib.