Table 1.
Baseline characteristics
| Lenalidomide group (n=1137) | Observation group (n=834) | |||
|---|---|---|---|---|
| Age, years | 66 (59–72) | 66 (59–72) | ||
| Age group | ||||
| 18–60 years | 361 (32%) | 251 (30%) | ||
| 61–70 years | 416 (37%) | 312 (37%) | ||
| >70 years | 360 (32%) | 271 (32%) | ||
| Sex | ||||
| Men | 696 (61%) | 527 (63%) | ||
| Women | 441 (39%) | 307 (37%) | ||
| Ethnicity | ||||
| White | 1060 (93%) | 773 (93%) | ||
| Black (black Caribbean, black African, other) | 26 (3%) | 17 (2%) | ||
| Asian (Indian, Pakistani, Bangladeshi, other) | 18 (2%) | 17 (2%) | ||
| Other | 10 (1%) | 8 (1%) | ||
| Unknown | 23 (2%) | 19 (2%) | ||
| Disease stage | ||||
| I | 327 (29%) | 239 (29%) | ||
| II | 439 (39%) | 349 (42%) | ||
| III | 291 (26%) | 192 (23%) | ||
| Unknown | 80 (7%) | 54 (6%) | ||
| Immunoglobulin subtype | ||||
| IgG | 699 (61%) | 494 (59%) | ||
| IgA | 272 (24%) | 219 (26%) | ||
| IgM | 7 (1%) | 3 (<1%) | ||
| IgD | 12 (1%) | 6 (1%) | ||
| Light-chain only | 137 (12%) | 108 (13%) | ||
| Non-secretor | 9 (1%) | 2 (<1%) | ||
| Unknown | 1 (<1%) | 2 (<1%) | ||
| Creatinine, μmol/L | 85 (71–103) | 84 (69–105) | ||
| Unknown | 3 (<1%) | 1 (<1%) | ||
| Lactate dehydrogenase, IU/L | 262 (178–381) | 271 (183–366) | ||
| Unknown | 251 (22%) | 175 (21%) | ||
| Cytogenetic risk assessment available | 447 (39%) | 327 (39%) | ||
| Cytogenetic risk | ||||
| Standard | 228/447 (51%) | 184/327 (56%) | ||
| High risk* | 166/447 (37%) | 113/327 (35%) | ||
| Ultra-high risk* | 53/447 (12%) | 30/327 (9%) | ||
| Transplantation eligibility and induction regimen† | ||||
| Transplantation eligible | 730 (64%) | 518 (62%) | ||
| CTD | 236 (21%) | 194 (23%) | ||
| CRD | 260 (23%) | 207 (25%) | ||
| KCRD | 234 (21%) | 117 (14%) | ||
| Transplantation ineligible | 407 (36%) | 316 (38%) | ||
| Attenuated CTD | 194 (17%) | 150 (18%) | ||
| Attenuated CRD | 213 (19%) | 166 (20%) | ||
| CVD randomisation after minimal or partial response† | ||||
| Allocated to CVD | 79 (7%) | 63 (8%) | ||
| Allocated to no CVD | 98 (9%) | 78 (9%) | ||
| Received CVD after stable or progressive disease | 16 (1%) | 8 (1%) | ||
| Response at maintenance randomisation | ||||
| Complete or very good partial response | 945 (83%) | 705 (85%) | ||
| Partial or minimal response | 172 (15%) | 118 (14%) | ||
| Stable or progressive disease | 8 (1%) | 6 (1%) | ||
| Unable to assess | 10 (1%) | 1 (<1%) | ||
| Unknown | 2 (<1%) | 4 (<1%) | ||
Data are median (IQR), n (%), or n/N (%). CRD=cyclophosphamide, lenalidomide, and dexamethasone. CTD=cyclophosphamide, thalidomide, and dexamethasone. CVD=cyclophosphamide, bortezomib, and dexamethasone. KCRD=carfilzomib, cyclophosphamide, lenalidomide, and dexamethasone. All responses were assessed according to International Myeloma Working Group criteria.
*
High-risk cytogenetic 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 one high-risk lesion.
†
Stratification factor in minimisation algorithm.