Comparison between efficacy and safety data reported for different VMP regimens
| Parameter . | This study . | GEM05>6524 . | VISTA2,3,7 . | |
|---|---|---|---|---|
| VMP (9 once-weekly cycles)* . | VMP (4/5 twice-/once-weekly cycles)† . | VMP (1/5 twice-/once-weekly cycles)‡ . | VMP (4/5 twice-/once-weekly cycles)† . | |
| n | 191 | 66 | 130 | 344 |
| Median age, y (range) | 71 (56-86) | 72 (65-85) | 73 (65-83) | 71 (57-90) |
| Overall response rate (≥PR), % | 79# | 86# | 80 (98 on maintenance) | 71§/74# |
| CR rate, % | 23 | 27 | 20 (44 on maintenance) | 30/33 |
| CR/nCR rate, % | NA | NA | 32 (59 on maintenance) | NR |
| Median follow-up, mo (range) | 20.9 (0.3-48.6) | 35.3 (0.1-48.0) | 24 (12-43) | 36.7 (NR) |
| Median PFS, mo | 27 | 26 | 34 | 22 |
| 3-y PFS rate, % | 46 | 39 | NR | NR |
| 3-y OS rate, % | 87 | 89 | 80 | 68.5 |
| Median no. cycles, n | 9 | 9 | NR | 9 |
| Sensory PN (any grade), % | 22 | 44 | NR | 44 |
| Grade 3/4, % | 2 | 14 | 5 (2/5 on VP/VT maintenance) | 13 |
| Discontinuation caused by PN, % | 4 | 16 | NR | 15 (3.2 VMP, 11.8 V only) |
| Bortezomib dose reductions caused by PN, % | 14 | 40 | NR | 22 |
| Bortezomib planned dose intensity, mg/m2/wk | 1.04 | 1.73 (cycles 1-4) | 1.73 (cycle 1) | 1.73 (cycles 1-4) |
| 0.87 (cycles 5-9) | 1.04 (cycles 2-6) | 0.87 (cycles 5-9) | ||
| Parameter . | This study . | GEM05>6524 . | VISTA2,3,7 . | |
|---|---|---|---|---|
| VMP (9 once-weekly cycles)* . | VMP (4/5 twice-/once-weekly cycles)† . | VMP (1/5 twice-/once-weekly cycles)‡ . | VMP (4/5 twice-/once-weekly cycles)† . | |
| n | 191 | 66 | 130 | 344 |
| Median age, y (range) | 71 (56-86) | 72 (65-85) | 73 (65-83) | 71 (57-90) |
| Overall response rate (≥PR), % | 79# | 86# | 80 (98 on maintenance) | 71§/74# |
| CR rate, % | 23 | 27 | 20 (44 on maintenance) | 30/33 |
| CR/nCR rate, % | NA | NA | 32 (59 on maintenance) | NR |
| Median follow-up, mo (range) | 20.9 (0.3-48.6) | 35.3 (0.1-48.0) | 24 (12-43) | 36.7 (NR) |
| Median PFS, mo | 27 | 26 | 34 | 22 |
| 3-y PFS rate, % | 46 | 39 | NR | NR |
| 3-y OS rate, % | 87 | 89 | 80 | 68.5 |
| Median no. cycles, n | 9 | 9 | NR | 9 |
| Sensory PN (any grade), % | 22 | 44 | NR | 44 |
| Grade 3/4, % | 2 | 14 | 5 (2/5 on VP/VT maintenance) | 13 |
| Discontinuation caused by PN, % | 4 | 16 | NR | 15 (3.2 VMP, 11.8 V only) |
| Bortezomib dose reductions caused by PN, % | 14 | 40 | NR | 22 |
| Bortezomib planned dose intensity, mg/m2/wk | 1.04 | 1.73 (cycles 1-4) | 1.73 (cycle 1) | 1.73 (cycles 1-4) |
| 0.87 (cycles 5-9) | 1.04 (cycles 2-6) | 0.87 (cycles 5-9) | ||
CR indicates complete response; NA, not applicable; nCR, near-complete response; NR, not reported; OS, overall survival; PFS, progression-free survival; PN, peripheral neuropathy; PR, partial response; TNT, time to next therapy; VMP, bortezomib, melphalan, prednisone; VP, bortezomib plus prednisone; and VT, bortezomib plus thalidomide.
Bortezomib 1.3 mg/m2 on days 1, 8, 15, and 22 for 9 5-week cycles.
Bortezomib 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 for 4 6-week cycles, and on days 1, 8, 22, and 29 for 56-week cycles.
Bortezomib 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 for 1 6-week cycle, and on days 1, 8, 15, and 22 for 55-week cycles; followed by maintenance including bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 every 3 months, for up to 3 years.
International Myeloma Working Group uniform criteria.17
European Group for Blood and Marrow Transplantation criteria.