Randomized trials involving lenalidomide maintenance following ASCT
| Study . | n . | Induction therapy . | Dosing schedule . | Duration of maintenance . | EFS or PFS (maintenance vs no) . | OS (maintenance vs no) . |
|---|---|---|---|---|---|---|
| CALGB 10010431,32 | 460 | ≤2 regimens; 94% received a regimen containing Thal, Len, and/or Bor | 10 mg continuous, increase up to 15 mg | Until progression | Median TTP: 53 vs 27 mo (P < .001) | Median follow-up of 65 mo: not reached vs 76 mo (P = .001) |
| IFM 2005-0233,34 | 614 | 46% received vincristine, doxorubicin, Dex and 46% received Bor and Dex | All patients received 2 cycles of consolidation (25 mg/d, 21 of 28 d) | Stopped due to concerns regarding second primary malignancies at a median time of 2 y (range, 1-3 y) | Median PFS: 41 vs 23 mo (P < .001) | Median follow-up 45 mo: 74 vs 76% (P = .7) |
| 21% received tandem transplant | Maintenance: 10 mg continuous, increase up to 15 mg | 4-y PFS: 43 vs 22% (P < .001); 5-y PFS: 42% vs 18% (P < .001) | 4-y OS: 73% vs 75% (P = .7); 5-y OS: 68% vs 67% (HR = 1) | |||
| 25% received induction reinforcement with DCEP | ||||||
| GIMEMA RV-2095 | 402 | 4 cycles Len/Dex followed by either tandem transplant (MEL200) or MPR | 10 mg (3 wk on, 1 wk off) | Until progression | Median PFS*: 42 vs 22 mo (P < .001) | 3-y OS*: 88% vs 79% (P = .14) |
| Study . | n . | Induction therapy . | Dosing schedule . | Duration of maintenance . | EFS or PFS (maintenance vs no) . | OS (maintenance vs no) . |
|---|---|---|---|---|---|---|
| CALGB 10010431,32 | 460 | ≤2 regimens; 94% received a regimen containing Thal, Len, and/or Bor | 10 mg continuous, increase up to 15 mg | Until progression | Median TTP: 53 vs 27 mo (P < .001) | Median follow-up of 65 mo: not reached vs 76 mo (P = .001) |
| IFM 2005-0233,34 | 614 | 46% received vincristine, doxorubicin, Dex and 46% received Bor and Dex | All patients received 2 cycles of consolidation (25 mg/d, 21 of 28 d) | Stopped due to concerns regarding second primary malignancies at a median time of 2 y (range, 1-3 y) | Median PFS: 41 vs 23 mo (P < .001) | Median follow-up 45 mo: 74 vs 76% (P = .7) |
| 21% received tandem transplant | Maintenance: 10 mg continuous, increase up to 15 mg | 4-y PFS: 43 vs 22% (P < .001); 5-y PFS: 42% vs 18% (P < .001) | 4-y OS: 73% vs 75% (P = .7); 5-y OS: 68% vs 67% (HR = 1) | |||
| 25% received induction reinforcement with DCEP | ||||||
| GIMEMA RV-2095 | 402 | 4 cycles Len/Dex followed by either tandem transplant (MEL200) or MPR | 10 mg (3 wk on, 1 wk off) | Until progression | Median PFS*: 42 vs 22 mo (P < .001) | 3-y OS*: 88% vs 79% (P = .14) |
Bor, bortezomib; DCEP, dexamethasone, cyclophosphamide, etoposide, cisplatin; Dex, dexamethasone; Thal, thalidomide.
Combining MEL200 and MPR groups.