Patient disposition by dose level in the phase 1 and phase 2 portions and numbers of patients experiencing DLT
| Dose level . | Bortezomib dose, mg/m2 . | Lenalidomide dose, mg . | Dexamethasone dose, mg (cycles 1-4/5-8) . | No. enrolled/treated . | DLT, n . |
|---|---|---|---|---|---|
| Phase 1 dose escalation | 22/21* | 2 | |||
| Dose level 1 | 1.0 | 15 | 40/20 | 3/3 | |
| Dose level 2 | 1.3 | 15 | 40/20 | 3/3 | |
| Dose level 3 | 1.3 | 20 | 40/20 | 4/3* | |
| Dose level 4 | 1.3 | 25 | 40/20 | 6/6 | 2 |
| Dose level 4M | 1.3 | 25 | 20/10 | 6/6 | |
| Phase 1 expanded cohort | 11/10† | ||||
| Dose level 4M | 1.3 | 25 | 20/10 | 11/10† | |
| Phase 2 | 35/35 | NA | |||
| Dose level 4M | 1.3 | 25 | 20/10 | 35/35 | NA |
| Dose level . | Bortezomib dose, mg/m2 . | Lenalidomide dose, mg . | Dexamethasone dose, mg (cycles 1-4/5-8) . | No. enrolled/treated . | DLT, n . |
|---|---|---|---|---|---|
| Phase 1 dose escalation | 22/21* | 2 | |||
| Dose level 1 | 1.0 | 15 | 40/20 | 3/3 | |
| Dose level 2 | 1.3 | 15 | 40/20 | 3/3 | |
| Dose level 3 | 1.3 | 20 | 40/20 | 4/3* | |
| Dose level 4 | 1.3 | 25 | 40/20 | 6/6 | 2 |
| Dose level 4M | 1.3 | 25 | 20/10 | 6/6 | |
| Phase 1 expanded cohort | 11/10† | ||||
| Dose level 4M | 1.3 | 25 | 20/10 | 11/10† | |
| Phase 2 | 35/35 | NA | |||
| Dose level 4M | 1.3 | 25 | 20/10 | 35/35 | NA |
DLT indicates dose-limiting toxicity; and NA, not applicable.
One patient did not receive treatment because of elevated creatinine and was not included in determination of maximum tolerated dose; a replacement patient was enrolled to dose level 3.
One patient was enrolled but did not receive study treatment because of acute renal failure, and was replaced.