Table 1.
Adjudicated response rates
| Placebo (n=229)
|
Lenalidomide (n=231) | ||||
|---|---|---|---|---|---|
| No Crossover (n=143) |
Crossover (n=86) | All Placebo (n=229) |
|||
|
| |||||
| Time of Randomisation | CR | 33 (14%) | 20 (9%) | 53 (23%) | 48 (21%) |
| VGPR | 60 (26%) | 40 (17%) | 100 (44%) | 80 (35%) | |
| PR | 32 (14%) | 20 (9%) | 52 (23%) | 78 (34%) | |
| SD | 4 (2%) | 1 (<1%) | 5 (2%) | 7 (3%) | |
| Rel/PD | 3 (1%) | 0 (0%) | 3 (1%) | 1 (<1%) | |
| NEa | 11 (5%) | 5 (2%) | 16 (7%) | 17 (7%) | |
| Off-studyb | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| VGPR/CR rate | 41% | 26% | 67% | 55% | |
|
| |||||
| One year post-ASCT | CR | 26 (11%) | 22 (10%) | 48 (21%) | 46 (20%) |
| VGPR | 32 (14%) | 36 (16%) | 68 (30%) | 65 (28%) | |
| PR | 8 (3%) | 13 (6%) | 21 (9%) | 36 (16%) | |
| SD | 0 (0%) | 0 (0%) | 0 (0%) | 2 (1%) | |
| Rel/PD | 15 (4%) | 6 (3%) | 13 (6%) | 19 (8%) | |
| NEa | 26 (11%) | 2 (1%) | 28 (12%) | 50 (22%) | |
| Off-studyb | 36 (16%) | 7 (3%) | 43 (19%) | 13 (6%) | |
| VGPR/CR rate | 25% | 25% | 51% | 48% | |
|
| |||||
| Two years post-ASCT | CR | 16 (7%) | 17 (7%) | 33 (14%) | 41 (18%) |
| VGPR | 8 (3%) | 22 (10%) | 30 (13%) | 43 (19%) | |
| PR | 2 (1%) | 13 (6%) | 15 (7%) | 19 (8%) | |
| SD | 0 (0%) | 0 (0%) | 0 (0%) | 1 (<1%) | |
| Rel/PD | 10 (4%) | 9 (4%) | 12 (5%) | 22 (10%) | |
| NEa | 29 (13%) | 13 (6%) | 42 (18%) | 61 (26%) | |
| Off-studyb | 78 (34%) | 12 (5%) | 90 (39%) | 44 (19%) | |
| VGPR/CR rate | 10% | 17% | 27% | 36% | |
|
| |||||
| Three years post-ASCT | CR | 5 (2%) | 8 (3%) | 13 (6%) | 30 (13%) |
| VGPR | 3 (1%) | 19 (8%) | 22 (10%) | 24 (10%) | |
| PR | 1 (<1%) | 4 (2%) | 5 (2%) | 8 (3%) | |
| SD | 0 (0%) | 0 (0%) | 0 (0%) | 1 (<1%) | |
| Rel/PD | 8 (3%) | 6 (3%) | 9 (4%) | 21 (9%) | |
| NEa | 31 (14%) | 27 (12%) | 58 (25%) | 84 (36%) | |
| Off-studyb | 95 (41%) | 22 (10%) | 117 (51%) | 63 (27%) | |
| VGPR/CR rate | 3% | 12% | 15% | 23% | |
a
Not evaluable because of missing data
b
Off-study because of prior disease relapse/progression