Table 2. Response rates.
Timepoint and response | Primary comparison | Rdc | Tdc | |
---|---|---|---|---|
KRdc | Control (Tdc/Rdc) | |||
At end of initial induction | n = 526 | n = 530 | n = 265 | n = 265 |
CR | 93 (17.7%) | 37 (7.0%) | 19 (7.1%) | 18 (6.8%) |
nCR | 203 (38.6) | 142 (26.8%) | 90 (34.0) | 52 (19.6%) |
VGPR | 137 (26.0%) | 133 (25.1%) | 63 (23.8%) | 70 (26.4%) |
≥VGPR | 433 (82.3%) | 312 (58.9%) | 172 (64.9%) | 140 (52.8%) |
PR | 43 (8.2%) | 154 (29.1%) | 66 (24.9%) | 88 (33.2%) |
MR | 3 (0.6%) | 18 (3.4%) | 7 (2.6%) | 11 (4.2%) |
SD | 1 (0.2%) | 3 (0.6%) | 0 (0.0%) | 3 (1.1%) |
PD | 6 (1.1%) | 12 (2.3%) | 5 (1.9%) | 7 (2.6%) |
Early death* | 6 (1.1%) | 5 (0.9%) | 2 (0.8%) | 3 (1.1%) |
Missing | 34 (6.7%) | 26 (4.9%) | 13 (4.9%) | 13 (4.9%) |
At 100 days post-ASCT$ | n = 394 | n = 338 | n = 179 | n = 159 |
CR | 122 (31.0%) | 81 (24.0%) | 41 (22.9%) | 40 (25.2%) |
nCR | 152 (38.6%) | 107 (31.7%) | 60 (33.5%) | 47 (29.6%) |
VGPR | 88 (22.3%) | 80 (23.7%) | 46 (25.7%) | 34 (21.4%) |
≥VGPR | 362 (91.9%) | 268 (79.3%) | 147 (82.1%) | 121 (76.1%) |
PR | 23 (5.8%) | 54 (16.0%) | 26 (14.5%) | 28 (17.9%) |
MR | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
SD | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
PD | 2 (0.5%) | 6 (1.8%) | 4 (2.2%) | 2 (1.3%) |
Early death# | 1 (0.3%) | 1 (0.6%) | 0 (0.0%) | 1 (0.6%) |
Missing | 6 (1.5%) | 9 (2.7%) | 2 (1.1%) | 7 (4.4%) |
MRD-negative status | ||||
At end of initial induction | n = 164 | n = 157 | n = 83 | n = 74 |
MRD negative | 90 (54.9%) | 20 (12.7%) | 18 (21.7%) | 8 (10.8%) |
At day 100 after ASCT | n = 202 | n = 160 | n = 79 | n = 81 |
MRD negative | 152 (75.2%) | 80 (50.0%) | 40 (50.6%) | 40 (49.4%) |
Data given as n (percent).
*All-cause death within 60 days of randomisation.
$Reported of these undergoing ASCT.
#All-cause death within 100 days of high-dose melphalan dose.
ASCT, autologous stem cell transplantation; CR, complete response; KRdc, carfilzomib, lenalidomide, dexamethasone, and cyclophosphamide; MR, minimal response; MRD, minimal residual disease; nCR, complete response without bone marrow confirmation; PD, progressive disease; PR, partial response; SD, stable disease; Rdc, lenalidomide, dexamethasone, and cyclophosphamide; Tdc, thalidomide, dexamethasone, and cyclophosphamide; VGPR, very good partial response.