Baseline patient characteristics
| . | 30 mg/m2 (N = 4) . | 40 mg/m2 (N = 6) . | 50 mg/m2 (N = 6) . | Original 50 mg/m2 (N = 2) . | Phase 2 (50 mg/m2) (N = 9) . | Total (N = 27) . |
|---|---|---|---|---|---|---|
| Age | ||||||
| Median (range) | 70.0 (57.0-76.0) | 62.5 (49.0-69.0) | 61.5 (59.0-75.0) | 72.5 (70.0-75.0) | 70.0 (57.0-76.0) | 66.0 (49.0-81.0) |
| Gender | ||||||
| Female | 1 (25.0%) | 4 (66.7%) | 3 (50.0%) | 0 (0.0%) | 1 (25.0%) | 13 (48.1%) |
| Male | 3 (75.0%) | 2 (33.3%) | 3 (50.0%) | 2 (100.0%) | 3 (75.0%) | 14 (51.9%) |
| Months from diagnosis to registration | ||||||
| Median (range) | 31.9 (20.9-47.1) | 43.8 (10.1-67.9) | 66.7 (6.7-134.3) | 113.6 (20.1-207.1) | 31.9 (20.9-47.1) | 41.6 (6.7-207.1) |
| International staging | ||||||
| Stage 1 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (11.1%) | 1 (3.7%) |
| Stage 2 | 3 (75.0%) | 2 (33.3%) | 3 (50.0%) | 1 (50.0%) | 2 (22.2%) | 11 (40.7%) |
| Stage 3 | 1 (25.0%) | 4 (66.7%) | 3 (50.0%) | 1 (50.0%) | 6 (66.7%) | 15 (55.6%) |
| Prior exposure | ||||||
| Lenalidomide | 2 (50.0%) | 6 (100.0%) | 4 (66.7%) | 1 (50.0%) | 6 (66.7%) | 19 (70.4%) |
| Bortezomib | 3 (75.0%) | 5 (83.3%) | 6 (100.0%) | 2 (100.0%) | 8 (88.9%) | 24 (88.9%) |
| Metaphase cytogenetics | ||||||
| Normal | 2 (50.0%) | 2 (33.3%) | 2 (33.3%) | 1 (50.0%) | 3 (33.3%) | 10 (37.0%) |
| Abnormal | 2 (50.0%) | 3 (50.0%) | 4 (66.7%) | 1 (50.0%) | 5 (55.6%) | 15 (55.6%) |
| Not done | 0 (0.0%) | 1 (16.7%) | 0 (0.0%) | 0 (0.0%) | 1 (11.1%) | 2 (7.4%) |
| FISH result | ||||||
| 13q- | 2 | 2 | 2 | 0 | 3 | 9 |
| 17p- | 1 | 1 | 1 | 0 | 2 | 5 |
| t(11;14) | 2 | 2 | 1 | 0 | 1 | 6 |
| t(4;14) | 1 | 0 | 1 | 0 | 0 | 2 |
| t(14;16) | 0 | 0 | 0 | 1 | 1 | 2 |
| . | 30 mg/m2 (N = 4) . | 40 mg/m2 (N = 6) . | 50 mg/m2 (N = 6) . | Original 50 mg/m2 (N = 2) . | Phase 2 (50 mg/m2) (N = 9) . | Total (N = 27) . |
|---|---|---|---|---|---|---|
| Age | ||||||
| Median (range) | 70.0 (57.0-76.0) | 62.5 (49.0-69.0) | 61.5 (59.0-75.0) | 72.5 (70.0-75.0) | 70.0 (57.0-76.0) | 66.0 (49.0-81.0) |
| Gender | ||||||
| Female | 1 (25.0%) | 4 (66.7%) | 3 (50.0%) | 0 (0.0%) | 1 (25.0%) | 13 (48.1%) |
| Male | 3 (75.0%) | 2 (33.3%) | 3 (50.0%) | 2 (100.0%) | 3 (75.0%) | 14 (51.9%) |
| Months from diagnosis to registration | ||||||
| Median (range) | 31.9 (20.9-47.1) | 43.8 (10.1-67.9) | 66.7 (6.7-134.3) | 113.6 (20.1-207.1) | 31.9 (20.9-47.1) | 41.6 (6.7-207.1) |
| International staging | ||||||
| Stage 1 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (11.1%) | 1 (3.7%) |
| Stage 2 | 3 (75.0%) | 2 (33.3%) | 3 (50.0%) | 1 (50.0%) | 2 (22.2%) | 11 (40.7%) |
| Stage 3 | 1 (25.0%) | 4 (66.7%) | 3 (50.0%) | 1 (50.0%) | 6 (66.7%) | 15 (55.6%) |
| Prior exposure | ||||||
| Lenalidomide | 2 (50.0%) | 6 (100.0%) | 4 (66.7%) | 1 (50.0%) | 6 (66.7%) | 19 (70.4%) |
| Bortezomib | 3 (75.0%) | 5 (83.3%) | 6 (100.0%) | 2 (100.0%) | 8 (88.9%) | 24 (88.9%) |
| Metaphase cytogenetics | ||||||
| Normal | 2 (50.0%) | 2 (33.3%) | 2 (33.3%) | 1 (50.0%) | 3 (33.3%) | 10 (37.0%) |
| Abnormal | 2 (50.0%) | 3 (50.0%) | 4 (66.7%) | 1 (50.0%) | 5 (55.6%) | 15 (55.6%) |
| Not done | 0 (0.0%) | 1 (16.7%) | 0 (0.0%) | 0 (0.0%) | 1 (11.1%) | 2 (7.4%) |
| FISH result | ||||||
| 13q- | 2 | 2 | 2 | 0 | 3 | 9 |
| 17p- | 1 | 1 | 1 | 0 | 2 | 5 |
| t(11;14) | 2 | 2 | 1 | 0 | 1 | 6 |
| t(4;14) | 1 | 0 | 1 | 0 | 0 | 2 |
| t(14;16) | 0 | 0 | 0 | 1 | 1 | 2 |