Maintenance studies with lenalidomide in patients after ASCT and after conventional chemotherapy
| Study group . | Median age, y (no. of patients) . | Induction consolidation therapy . | Maintenance dose, duration of treatment . | Improvement in quality of response . | TTP or PFS* . | OS* . | Survival after relapse . | Lenalidomide tolerance . |
|---|---|---|---|---|---|---|---|---|
| CALGB: McCarthy et al38 (2011) | NA (N = 460) | Any, followed by ASCT (M 200) | (A) 10 mg/d with dose adaptations (5-15 mg/d) continuously† | NA | (A) TTP, median 42 mo | No. of deaths: (A) 23 | NA; 78% of eligible patients of the control group had been crossed over to lenalidomide treatment | Discontinuation because of AEs (A) 12% (B) 2% Because of other reasons: (A) 13% (B) 6% SPM: (A) 15, (B) 6 |
| (B) Placebo | (B) 22 mo P < .0001 | (B) 39 P = .018 | ||||||
| IFM: Attal et al39,40 (2010) | 55 (N = 614) | VAD, Vel-dexamethasone and other induction therapy, single or double ASCT | (A) 10-15 mg/d continuously†‡ | (A) CR: 25% VGPR: 76% | (A) 42 mo | 5 y: (A) 79% | (A) 12 mo | Discontinuation because of AEs A) 21% SPM: 26 |
| Consolidation: lenalidomide 25 mg/d, days 1-21, every 28 d, 2 cycles | (B) Placebo | (B) CR: 23% VGPR: 71% | (B) 24 mo P < .0000001 | (B) 73% | (B) 12 mo | (B) 15% SPM: 6 | ||
| P = .49 P = .13 | ||||||||
| MM015: Palumbo et al42,43 (2010) | 71 (N = 459) | (A) MPR-R | (A) 10 mg/d, days 1-21, continuously† | (A) 77% P < .001 | (A) 31 mo | 4-y estimate (A-C) 58%-59% | NA | Discontinuation because of AEs (A) 20% SPM: 8% |
| (B) MPR | (B) Placebo | (B) 68% | (B) 14 mo | (B) 16% SPM: 6.6% | ||||
| (C) MP | (C) Placebo | (C) 50% | (C) 13 mo A vs C, P < .001 | (C) 2.9% SPM: 2.6% |
| Study group . | Median age, y (no. of patients) . | Induction consolidation therapy . | Maintenance dose, duration of treatment . | Improvement in quality of response . | TTP or PFS* . | OS* . | Survival after relapse . | Lenalidomide tolerance . |
|---|---|---|---|---|---|---|---|---|
| CALGB: McCarthy et al38 (2011) | NA (N = 460) | Any, followed by ASCT (M 200) | (A) 10 mg/d with dose adaptations (5-15 mg/d) continuously† | NA | (A) TTP, median 42 mo | No. of deaths: (A) 23 | NA; 78% of eligible patients of the control group had been crossed over to lenalidomide treatment | Discontinuation because of AEs (A) 12% (B) 2% Because of other reasons: (A) 13% (B) 6% SPM: (A) 15, (B) 6 |
| (B) Placebo | (B) 22 mo P < .0001 | (B) 39 P = .018 | ||||||
| IFM: Attal et al39,40 (2010) | 55 (N = 614) | VAD, Vel-dexamethasone and other induction therapy, single or double ASCT | (A) 10-15 mg/d continuously†‡ | (A) CR: 25% VGPR: 76% | (A) 42 mo | 5 y: (A) 79% | (A) 12 mo | Discontinuation because of AEs A) 21% SPM: 26 |
| Consolidation: lenalidomide 25 mg/d, days 1-21, every 28 d, 2 cycles | (B) Placebo | (B) CR: 23% VGPR: 71% | (B) 24 mo P < .0000001 | (B) 73% | (B) 12 mo | (B) 15% SPM: 6 | ||
| P = .49 P = .13 | ||||||||
| MM015: Palumbo et al42,43 (2010) | 71 (N = 459) | (A) MPR-R | (A) 10 mg/d, days 1-21, continuously† | (A) 77% P < .001 | (A) 31 mo | 4-y estimate (A-C) 58%-59% | NA | Discontinuation because of AEs (A) 20% SPM: 8% |
| (B) MPR | (B) Placebo | (B) 68% | (B) 14 mo | (B) 16% SPM: 6.6% | ||||
| (C) MP | (C) Placebo | (C) 50% | (C) 13 mo A vs C, P < .001 | (C) 2.9% SPM: 2.6% |