Outcomes from randomized phase 3 clinical trials of different treatment regimens in elderly patients with NDMM
| Regimen . | Median age, y . | Dosing . | CR rate, % . | Median PFS, mo . | Median OS, mo . | Discontinuation rate, % . | Nonhematologic grade 3-4 AEs, % . |
|---|---|---|---|---|---|---|---|
| MPT48 | 69 | M: 0.25 mg/kg on days 1-4 for twelve 6-wk cycles P: 40 mg/m2 on days 1-4 for twelve 6-wk cycles T: 400 mg/d for twelve 6-wk cycles | 13 | 28 | 52 | 45 | 42 |
| MPT49,50 | 72 | M: 4 mg/m2 on days 1-7 for six 4-wk cycles P: 40 mg/m2 on days 1-7 for six 4-wk cycles T: 100 mg/d until relapse | 16 | 22 | 45 | 34 | 55* |
| MPT52 | 72 | M: 0.25 mg/kg on days 1-5 for eight 4-wk cycles P: 1 mg/kg on days 1-5 for eight 4-wk cycles T: 200 mg/d for eight 4-wk cycles, followed by 50 mg/d until relapse | 23† | 13‡ | 40 | 36 | 50 |
| MPT53 | 78 | M: 0.2 mg/kg on days 1-4 for twelve 6-wk cycles P: 2 mg/kg on days 1-4 for twelve 6-wk cycles T: 100 mg/d for twelve 6-wk cycles | 7 | 24 | 44 | 42 | NA |
| MPT54 | 74 | M: 0.25 mg/kg on days 1-4 for 6-wk cycles until plateau P: 100 mg/d on days 1-4 for 6-wk cycles until plateau T: 400 mg/d until plateau, reduced to 200 mg/d until progression | 13 | 15 | 29 | 32 | 40 |
| MPT55 | 69 | M: 9 mg/m2 on days 1-4 for eight 6-wk cycles P: 60 mg/m2 on days 1-4 for eight 6-wk cycles T: 100 mg/d for eight 6-wk cycles, followed by100 mg/d until relapse | 9 | 21§ | 26 | 16 | NA |
| VMP47,56 | 71 | V: 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 for first four 6-wk cycles; days 1, 8, 15, and 22 for subsequent five 6-wk cycles M: 9 mg/m2 on days 1-4 for five 6-wk cycles P: 60 mg/m2 on days 1-4 for five 6-wk cycles | 30 | NA | Not reached | 34 | 91* |
| VMP57 | 71 | V: 1.3 mg/m2 on days 1, 8, 15, and 22 for nine 5-wk cycles M: 9 mg/m2 on days 1-4 for nine 5-wk cycles P: 60 mg/m2 on days 1-4 for nine 5-wk cycles | 24 | 23 | Not reached | 17 | 33 |
| MPR-R58 | NA | M: 0.18 mg/kg on days 1-4 for nine 4-wk cycles P: 2 mg/kg on days 1-4 for nine 4-wk cycles R: 10 mg on days 1-21 for nine 4-wk cycles R: 10 mg/d until relapse | 16 | 31 | Not reached | 14¶ | NA |
| Rd51 | 66 | R: 25 mg on days 1-21 d: 40 mg on days 1, 8, 15, 22 in 4-wk cycles | 4 | 25 | Not reached | 19 | NA |
| VMPT57 | 71 | V: 1.3 mg/m2 on days 1, 8, 15, and 22 for nine 5-wk cycles and on days 1, 15 until relapse M: 9 mg/m2 on days 1-4 for nine 5-wk cycles P: 60 mg/m2 on days 1-4 for nine 5-wk cycles T: 50 mg daily until relapse | 38 | Not reached | Not reached | 23 | 46 |
| Regimen . | Median age, y . | Dosing . | CR rate, % . | Median PFS, mo . | Median OS, mo . | Discontinuation rate, % . | Nonhematologic grade 3-4 AEs, % . |
|---|---|---|---|---|---|---|---|
| MPT48 | 69 | M: 0.25 mg/kg on days 1-4 for twelve 6-wk cycles P: 40 mg/m2 on days 1-4 for twelve 6-wk cycles T: 400 mg/d for twelve 6-wk cycles | 13 | 28 | 52 | 45 | 42 |
| MPT49,50 | 72 | M: 4 mg/m2 on days 1-7 for six 4-wk cycles P: 40 mg/m2 on days 1-7 for six 4-wk cycles T: 100 mg/d until relapse | 16 | 22 | 45 | 34 | 55* |
| MPT52 | 72 | M: 0.25 mg/kg on days 1-5 for eight 4-wk cycles P: 1 mg/kg on days 1-5 for eight 4-wk cycles T: 200 mg/d for eight 4-wk cycles, followed by 50 mg/d until relapse | 23† | 13‡ | 40 | 36 | 50 |
| MPT53 | 78 | M: 0.2 mg/kg on days 1-4 for twelve 6-wk cycles P: 2 mg/kg on days 1-4 for twelve 6-wk cycles T: 100 mg/d for twelve 6-wk cycles | 7 | 24 | 44 | 42 | NA |
| MPT54 | 74 | M: 0.25 mg/kg on days 1-4 for 6-wk cycles until plateau P: 100 mg/d on days 1-4 for 6-wk cycles until plateau T: 400 mg/d until plateau, reduced to 200 mg/d until progression | 13 | 15 | 29 | 32 | 40 |
| MPT55 | 69 | M: 9 mg/m2 on days 1-4 for eight 6-wk cycles P: 60 mg/m2 on days 1-4 for eight 6-wk cycles T: 100 mg/d for eight 6-wk cycles, followed by100 mg/d until relapse | 9 | 21§ | 26 | 16 | NA |
| VMP47,56 | 71 | V: 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 for first four 6-wk cycles; days 1, 8, 15, and 22 for subsequent five 6-wk cycles M: 9 mg/m2 on days 1-4 for five 6-wk cycles P: 60 mg/m2 on days 1-4 for five 6-wk cycles | 30 | NA | Not reached | 34 | 91* |
| VMP57 | 71 | V: 1.3 mg/m2 on days 1, 8, 15, and 22 for nine 5-wk cycles M: 9 mg/m2 on days 1-4 for nine 5-wk cycles P: 60 mg/m2 on days 1-4 for nine 5-wk cycles | 24 | 23 | Not reached | 17 | 33 |
| MPR-R58 | NA | M: 0.18 mg/kg on days 1-4 for nine 4-wk cycles P: 2 mg/kg on days 1-4 for nine 4-wk cycles R: 10 mg on days 1-21 for nine 4-wk cycles R: 10 mg/d until relapse | 16 | 31 | Not reached | 14¶ | NA |
| Rd51 | 66 | R: 25 mg on days 1-21 d: 40 mg on days 1, 8, 15, 22 in 4-wk cycles | 4 | 25 | Not reached | 19 | NA |
| VMPT57 | 71 | V: 1.3 mg/m2 on days 1, 8, 15, and 22 for nine 5-wk cycles and on days 1, 15 until relapse M: 9 mg/m2 on days 1-4 for nine 5-wk cycles P: 60 mg/m2 on days 1-4 for nine 5-wk cycles T: 50 mg daily until relapse | 38 | Not reached | Not reached | 23 | 46 |
CR indicates complete response; PFS, progression-free survival; OS, overall survival; AE, adverse event; MPR-R, melphalan, prednisone, and lenalidomide followed by lenalidomide maintenance; NA, not available; Rd, lenalidomide plus low-dose dexamethasone; VMP, bortezomib, melphalan, and prednisone; and VMPT, bortezomib, melphalan, prednisone, and thalidomide.
Both hematologic and nonhematologic AEs.
CR plus very good partial response (CR alone not available).
Event-free survival.
Disease-free survival.
Includes both patients who received lenalidomide maintenance and those who did not.