TABLE 4.
Incidence of Lenalidomide Associated Thrombosis in Recent Clinical Trials
| Study | Regimen | Disease status | No. of patients | Rate of deep vein thrombosis | Thromboprophylaxis |
|---|---|---|---|---|---|
| Weber, 200627 | Lenalidomide 25 mg Days 1–21 every 28 d plus dexamethasone 40 mg Days 1–4, 9–12, 17–20 every 28 d | Relapsed, refractory | 177 | 15% | None |
| Zonder, 200525 | Lenalidomide 25 mg Days 1–28 every 35 d plus dexamethasone 40 mg Days 1–4, 9–12, 17–20 every 35 d | Newly diagnosed | 38 | 75%; reduced to 19% after institution of aspirin prophylaxis | ASA in the second phase |
| Richardson, 200628 | Lenalidomide 30 mg daily (or15 mg twice a d) administered on Days 1–21 every 28 dd with or without dexamethasone Days 1–4, 15–18 every 28 d | Relapsed, refractory | 102 | 3% (rate is 4.4% among the 68 patients who received lenalidomide plus dexamethasone | None |
| Rajkumar, 200726 | Lenalidomide 25 mg Days 1–21 every 28 d plus dexamethasone 40 mg Days 1–4, 9–12, 17–20 every 28 d | Newly diagnosed | 223 | 22.1% | ASA (randomized between coumadin and ASA in the expansion phase) |
| Rajkumar, 200726 | Lenalidomide 25 mg Days 1–21 every 28 d plus dexamethasone 40 mg Days 1, 8, 15, 22 every 28 d | Relapsed, refractory | 222 | 6.1% | ASA |
ASA indicates aspirin; High dose dex, dexamethasone 40 mg (Days 1–4, 9–12 and 17–20 in a 28 d cycle).