Table 1. Baseline characteristics.
| Characteristic | Primary endpoint comparison | Rdc (n = 265) |
Tdc (n = 265) |
|
|---|---|---|---|---|
| KRdc (n = 526) |
Control (Tdc/Rdc combined) (n = 530) |
|||
| Median age (range)—years | 61 (33 to 75) | 62 (36 to 74) | 62 (36 to 74) | 61 (38 to 74) |
| Age group—n (%) | ||||
| ≤65 years | 385 (73.2%) | 370 (69.8%) | 179 (67.5%) | 191 (72.1%) |
| >65 years | 141 (26.8%) | 160 (30.2%) | 86 (32.5%) | 74 (27.9%) |
| >70 years | 12 (2.3%) | 24 (4.5%) | 12 (4.5%) | 12 (4.5%) |
| Sex—n (%) | ||||
| Male | 317 (60.3%) | 326 (61.5%) | 170 (64.2%) | 156 (58.9%) |
| Female | 209 (39.7%) | 204 (38.5%) | 95 (35.8%) | 109 (41.1%) |
| Ethnicity—n (%) | ||||
| White | 494 (93.9%) | 482 (90.9%) | 243 (91.7%) | 239 (90.2%) |
| Black (Black Caribbean, Black African, other) | 9 (1.7%) | 6 (1.1%) | 5 (1.9) | 1 (0.4%) |
| Asian (Indian, Pakistani, Bangladeshi, other) | 9 (1.7%) | 17 (3.2%) | 7 (2.6%) | 10 (3.87%) |
| Other | 8 (1.5%) | 2 (0.4%) | 1 (0.4%) | 1 (0.4%) |
| Unknown | 6 (1.1%) | 23 (4.3%) | 9 (3.4%) | 14 (5.3%) |
| WHO performance status—n (%) | ||||
| 0 | 225 (42.8%) | 224 (42.3%) | 101 (38.1%) | 123 (46.4%) |
| 1 | 194 (36.9%) | 182 (34.3%) | 98 (37.0%) | 86 (32.5%) |
| 2 | 58 (11.0%) | 63 (11.9%) | 30 (11.3%) | 33 (12.5%) |
| 3 | 20 (3.8%) | 26 (4.9%) | 17 (6.4%) | 9 (3.4%) |
| 4 | 1 (0.2%) | 2 (0.4%) | 1 (0.4%) | 1 (0.4%) |
| Unknown | 28 (5.3%) | 31 (5.8%) | 18 (6.8%) | 13 (4.9%) |
| ISS stage—n (%) | ||||
| I | 167 (31.7%) | 164 (30.9%) | 80 (30.2%) | 84 (31.7%) |
| II | 198 (37.6%) | 194 (36.6%) | 95 (35.8%) | 99 (37.4%) |
| III | 117 (22.2%) | 122 (23.0%) | 63 (23.8%) | 59 (22.3%) |
| Unknown | 44 (8.4%) | 50 (9.4%) | 27 (10.2%) | 23 (8.7%) |
| Immunoglobulin subtype—n (%) | ||||
| IgG | 299 (56.8) | 345 (65.1%) | 173 (65.3%) | 172 (64.9%) |
| IgA | 131 (24.9%) | 108 (20.4%) | 49 (18.5%) | 59 (22.3%) |
| IgM | 4 (0.8%) | 3 (0.6%) | 1 (0.4%) | 2 (0.8%) |
| IgD | 5 (1.0%) | 4 (0.8%) | 2 (0.8%) | 2 (0.8%) |
| Light chain only | 81 (15.4%) | 66 (12.5%) | 38 (14.3%) | 28 (10.6%) |
| Non-secretor | 4 (0.8%) | 4 (0.8%) | 2 (0.8%) | 2 (0.8%) |
| Unknown | 2 (0.4%) | 0 | 0 | 0 |
| Median creatinine (range)—μmol/l | 82 (40 to 395) | 81 (30 to 649) | 82 (36 to 446) | 80 (30 to 649) |
| Unknown—n (%) | 2 (0.4%) | 2 (0.4%) | 1 (0.4%) | 1 (0.4%) |
| Median LDH (range)—IU/l | 248 (83 to 1,510) | 257 (2 to 1,477) | 257 (5 to 1,477) | 256 (2 to 774) |
| Unknown—n (%) | 113 (21.5%) | 125 (23.6%) | 66 (24.9%) | 59 (22.3%) |
| Molecular risk assessment available—n (%) | 204 (38.8%) | 179 (33.8%) | 85 (32.1%) | 94 (35.5%) |
| Molecular risk—n (% of those available) | ||||
| Standard | 101 (49.5%) | 103 (57.5%) | 47 (55.3%) | 56 (59.6%) |
| High risk† | 81 (39.7%) | 60 (33.5%) | 31 (36.5%) | 29 (30.9%) |
| Ultra-high risk† | 22 (10.8%) | 16 (8.9%) | 7 (8.2%) | 9 (9.6%) |
| Molecular risk lesions—n (% of those available) | ||||
| t(4;14) | 28 (13.7%) | 22 (11.2%) | 11 (12.9%) | 11 (11.7%) |
| t(14;16) | 7 (3.4%) | 0 (0%) | 0 (0%) | 0 (0%) |
| t(14;20) | 2 (1.0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| del(17p) | 17 (8.3%) | 11 (6.1%) | 4 (4.7%) | 7 (7.4%) |
| gain(1q) | 71 (34.8%) | 60 (33.5%) | 30 (35.3%) | 30 (31.9%) |
†High-risk molecular abnormalities were defined as gain(1q), t(4;14), t(14;16), t(14;20), and del(17p). Ultra-high risk was defined as the presence of more than 1 high-risk lesion.
ISS, International Staging System; KRdc, carfilzomib, lenalidomide, dexamethasone, and cyclophosphamide; LDH, lactate dehydrogenase; Rdc, lenalidomide, dexamethasone, and cyclophosphamide; Tdc, thalidomide, dexamethasone, and cyclophosphamide.