Table 1.
Results from the two Phase III studies evaluating lenalidomide plus dexamethasone versus placebo plus dexamethasone
| Study | Regimen | Schedule | N | ≥PR | CR | TTE | Key toxicities |
|---|---|---|---|---|---|---|---|
| Dimpopoulos et al (MM-010)25 | Len-dex | Len 25 mg on days 1–21 of 28-day cycle Dex 40 mg on days 1–4, 9–12, 17–20 for the first four cycles, thereafter 40 mg days 1–4 |
176 | 60.2% | 15.9% | Median TTP: 11.3 months Median OS: not reached |
Grade ≥ 3 venous thromboembolism: 11.4% Grade ≥ 3 neutropenia: 29.5% Grade ≥ 3 infection: 11.3% |
| Dex | Dex 40 mg on days 1–4, 9–12, 17–20 for the first four 4-week cycles, thereafter 40 mg days 1–4 | 175 | 24.0% | 3.4% | Median TTP: 4.7 months Median OS: 20.6 months |
Grade ≥ 3 venous thromboembolism: 4.6% Grade ≥ 3 neutropenia: 2.3% Grade ≥ 3 infection: 6.2% |
|
| Weber et al (MM-009)26 | Len-dex | Len 25 mg on days 1–21 of 28-day cycle Dex 40 mg on days 1–4, 9–12, 17–20 for the first four cycles, thereafter 40 mg days 1–4 |
177 | 61.0% | 14.1% | Median TTP: 11.1 months Median OS: 29.6 months |
Grade ≥ 3 venous thromboembolism: 14.7% Grade ≥ 3 neutropenia: 41.2% Grade ≥ 3 infection: 21.4% |
| Dex | Dex 40 mg on days 1–4, 9–12, 17–20 for the first four 4-week cycles, thereafter 40 mg days 1–4 | 176 | 19.9% | 0.6% | Median TTP: 4.7 months Median OS: 20.2 months |
Grade ≥ 3 venous thromboembolism: 3.4% Grade ≥ 3 neutropenia: 4.6% Grade ≥ 3 infection: 12.0% |
Abbreviations: CR, complete response; PR, partial response; TTE, time to events; TTP, time to progression; OS, overall survival; Len, lenalidomine; Dex, dexamethasone.