Bortezomib-dexamethasone with or without daratumumab in MM patients with at least 1 prior line of therapy (Castor study)
| . | NCT02136134 (CASTOR)48,61 . | |
|---|---|---|
| Phase | Phase 3 | |
| Regimen | Vd | DVd |
| Treatments | Bortezomib 1.3 mg/m2: days 1, 4, 8, 11 of 21-d cycle; 8 cycles | Daratumumab (16 mg/kg): weekly ×10, Q3W until end of Vd, then Q4W until progression |
| Dexamethasone 20 mg: days 1, 2, 4, 5, 8, 9, 11,12; 8 cycles (20 mg once weekly if age >75 y) | Bortezomib 1.3 mg/m2: days 1, 4, 8, 11 of 21-d cycle; 8 cycles | |
| Dexamethasone 20 mg: days 1, 2, 4, 5, 8, 9, 11,12; 8 cycles (20 mg once weekly if age >75 y) | ||
| No. of patients | 247 | 251 |
| Median age, y | 64 | 64 |
| Median no. of prior therapies | 2 | 2 |
| Previous IMiD therapy, % | 80.2 | 71.3 |
| Previous PI therapy, % | 69.6 | 67.3 |
| IRR, % | Not applicable | 45.3 |
| ≥PR, % | 63.2 | 82.9 |
| ≥VGPR, % | 29.1 | 59.2 |
| ≥CR, % | 9.0 | 19.2 |
| MRD− disease (10−5), % | 2.4 | 10.4 |
| 12-mo PFS, % | 26.9 | 60.7 |
| OS | Median OS, not evaluable; HR, 077 | Median OS, not evaluable; HR, 0.77 |
| . | NCT02136134 (CASTOR)48,61 . | |
|---|---|---|
| Phase | Phase 3 | |
| Regimen | Vd | DVd |
| Treatments | Bortezomib 1.3 mg/m2: days 1, 4, 8, 11 of 21-d cycle; 8 cycles | Daratumumab (16 mg/kg): weekly ×10, Q3W until end of Vd, then Q4W until progression |
| Dexamethasone 20 mg: days 1, 2, 4, 5, 8, 9, 11,12; 8 cycles (20 mg once weekly if age >75 y) | Bortezomib 1.3 mg/m2: days 1, 4, 8, 11 of 21-d cycle; 8 cycles | |
| Dexamethasone 20 mg: days 1, 2, 4, 5, 8, 9, 11,12; 8 cycles (20 mg once weekly if age >75 y) | ||
| No. of patients | 247 | 251 |
| Median age, y | 64 | 64 |
| Median no. of prior therapies | 2 | 2 |
| Previous IMiD therapy, % | 80.2 | 71.3 |
| Previous PI therapy, % | 69.6 | 67.3 |
| IRR, % | Not applicable | 45.3 |
| ≥PR, % | 63.2 | 82.9 |
| ≥VGPR, % | 29.1 | 59.2 |
| ≥CR, % | 9.0 | 19.2 |
| MRD− disease (10−5), % | 2.4 | 10.4 |
| 12-mo PFS, % | 26.9 | 60.7 |
| OS | Median OS, not evaluable; HR, 077 | Median OS, not evaluable; HR, 0.77 |
DVd, daratumumab-bortezomib-dexamethasone; HR, hazard ratio; IMiD, immunomodulatory drug; PI, proteasome inhibitor; Q3W, once every 3 weeks; Vd, bortezomib-dexamethasone. Other abbreviations are explained in Table 1.