Patient disposition by cohort
| . | Once-weekly bortezomib, cohort no.: dose . | Twice-weekly bortezomib, cohort no.: dose . | Total (%) . | |||||
|---|---|---|---|---|---|---|---|---|
| 1: 0.7 mg/m2 . | 2: 1.0 mg/m2 . | 3: 1.3 mg/m2 . | 4: 1.6 mg/m2 . | 5: 0.7 mg/m2 . | 6: 1.0 mg/m2 . | 7: 1.3 mg/m2 . | ||
| No. of patients | 3 | 3 | 3 | 6* | 3 | 6* | 7 | 31 |
| Completed | 2 | 1 | 1 | 3 | 1 | 3 | — | 11 (35) |
| Ongoing | — | — | 1 | — | 1 | — | — | 2 (6) |
| Terminated early; primary reason | 1 | 2 | 1 | 3 | 1 | 3 | 7 | 18 (58) |
| Adverse event | — | 1 | 1 | 2* | 1 | — | 4 | 9 (29) |
| Patient choice | — | — | — | 1 | — | 2 | — | 3 (10) |
| Deterioration of overall condition | 1 | 1 | — | — | — | — | — | 2 (6) |
| Death | — | — | — | — | — | — | 1 | 1 (3) |
| Progression of amyloid markers | — | — | — | — | — | — | 1 | 1 (3) |
| KPS/organ function deterioration | — | — | — | — | — | 1 | — | 1 (3) |
| Other | — | — | — | — | — | — | 1 | 1 (3) |
| . | Once-weekly bortezomib, cohort no.: dose . | Twice-weekly bortezomib, cohort no.: dose . | Total (%) . | |||||
|---|---|---|---|---|---|---|---|---|
| 1: 0.7 mg/m2 . | 2: 1.0 mg/m2 . | 3: 1.3 mg/m2 . | 4: 1.6 mg/m2 . | 5: 0.7 mg/m2 . | 6: 1.0 mg/m2 . | 7: 1.3 mg/m2 . | ||
| No. of patients | 3 | 3 | 3 | 6* | 3 | 6* | 7 | 31 |
| Completed | 2 | 1 | 1 | 3 | 1 | 3 | — | 11 (35) |
| Ongoing | — | — | 1 | — | 1 | — | — | 2 (6) |
| Terminated early; primary reason | 1 | 2 | 1 | 3 | 1 | 3 | 7 | 18 (58) |
| Adverse event | — | 1 | 1 | 2* | 1 | — | 4 | 9 (29) |
| Patient choice | — | — | — | 1 | — | 2 | — | 3 (10) |
| Deterioration of overall condition | 1 | 1 | — | — | — | — | — | 2 (6) |
| Death | — | — | — | — | — | — | 1 | 1 (3) |
| Progression of amyloid markers | — | — | — | — | — | — | 1 | 1 (3) |
| KPS/organ function deterioration | — | — | — | — | — | 1 | — | 1 (3) |
| Other | — | — | — | — | — | — | 1 | 1 (3) |
One DLT seen in cohort 4 and in cohort 6. The DLT in cohort 4 resulted in treatment discontinuation, as shown, whereas the DLT in cohort 6 resolved following interruption of therapy; in the latter patient, bortezomib was recommenced with a dose reduction.