Patient outcome according to random assignment for lenalidomide maintenance or observation
. | Observation . | Lenalidomide maintenance . | Cox regression* . | ||
---|---|---|---|---|---|
HR . | 95% CI . | P . | |||
Total | 43 (100) | 45 (100) | |||
Outcomes | |||||
Relapse after second randomization | 12 (28) | 11 (24) | |||
Death after second randomization | 8 (19) | 4 (9) | |||
Relapse-free mortality after second randomization | 2 (5) | — | |||
At 3 years (% ± SE): | |||||
CIR† | 34 ± 10 | 28 ± 8 | 0.81 | 0.36-1.85 | .62 |
RFS† | 67 ± 7 | 75 ± 6 | 0.70 | 0.32-1.55 | .38 |
OS† | 84 ± 6 | 91 ± 4 | 0.51 | 0.15-1.72 | .28 |
MRD positive | |||||
Before second randomization | 2 (5) | 4 (9) | |||
After second randomization | 2 (5) | 1 (2) |
. | Observation . | Lenalidomide maintenance . | Cox regression* . | ||
---|---|---|---|---|---|
HR . | 95% CI . | P . | |||
Total | 43 (100) | 45 (100) | |||
Outcomes | |||||
Relapse after second randomization | 12 (28) | 11 (24) | |||
Death after second randomization | 8 (19) | 4 (9) | |||
Relapse-free mortality after second randomization | 2 (5) | — | |||
At 3 years (% ± SE): | |||||
CIR† | 34 ± 10 | 28 ± 8 | 0.81 | 0.36-1.85 | .62 |
RFS† | 67 ± 7 | 75 ± 6 | 0.70 | 0.32-1.55 | .38 |
OS† | 84 ± 6 | 91 ± 4 | 0.51 | 0.15-1.72 | .28 |
MRD positive | |||||
Before second randomization | 2 (5) | 4 (9) | |||
After second randomization | 2 (5) | 1 (2) |