Table 4.

Patient outcome according to random assignment for lenalidomide maintenance or observation

ObservationLenalidomide maintenanceCox regression*
HR95% CIP
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)    
ObservationLenalidomide maintenanceCox regression*
HR95% CIP
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)    

Data are n (%) unless otherwise stated.

*

Cox regression included maintenance treatment arm, induction treatment arm, and type of consolidation treatment as covariates.

Percentages are actuarial 3-year probabilities.

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