Overall response
| ITT . | Cohort 1 (n = 33) . | Cohort 2 (n = 30) . | All (n = 63) . |
|---|---|---|---|
| ORR | 88% | 93% | 90% |
| CR/nCR | 39% | 43% | 41% |
| VGPR or better | 61% | 60% | 60% |
| After 4 cycles | (n = 28) | (n = 27) | (n = 55) |
| ORR | 96% | 93% | 95% |
| CR/nCR | 46% | 48% | 47% |
| VGPR or better | 71% | 63% | 67% |
| Toxicity | |||
| Any ≥ Gr 3 AE | 48% | 37% | |
| Gr ≥ 3 Thrombocytopenia | 21% | 0% | |
| Gr ≥ 3 Neutropenia | 12% | 7% | |
| Gr ≥ 3 Anemia | 9% | 0% | |
| Gr ≥ 3 PN | 6% | 0% | |
| Any Gr PN | 64% | 57% | |
| Bortezomib doses reduced | 21% | 13% | |
| Dex dose reduced | 30% | 20% |
| ITT . | Cohort 1 (n = 33) . | Cohort 2 (n = 30) . | All (n = 63) . |
|---|---|---|---|
| ORR | 88% | 93% | 90% |
| CR/nCR | 39% | 43% | 41% |
| VGPR or better | 61% | 60% | 60% |
| After 4 cycles | (n = 28) | (n = 27) | (n = 55) |
| ORR | 96% | 93% | 95% |
| CR/nCR | 46% | 48% | 47% |
| VGPR or better | 71% | 63% | 67% |
| Toxicity | |||
| Any ≥ Gr 3 AE | 48% | 37% | |
| Gr ≥ 3 Thrombocytopenia | 21% | 0% | |
| Gr ≥ 3 Neutropenia | 12% | 7% | |
| Gr ≥ 3 Anemia | 9% | 0% | |
| Gr ≥ 3 PN | 6% | 0% | |
| Any Gr PN | 64% | 57% | |
| Bortezomib doses reduced | 21% | 13% | |
| Dex dose reduced | 30% | 20% |
ITT indicates intention to treat; ORR, overall response; CR, complete response; nCR, near complete response; VGPR, very good partial response; GR, grade; AE, adverse event; and PN, peripheral neuropathy.