Baseline characteristics
| . | Arm B (4 mg) (N = 35) . | Arm C (5.5 mg) (N = 35) . |
|---|---|---|
| Age, median (range) | 71.0 (46.0-83.0) | 69.0 (51.0-84.0) |
| Male, N (%) | 16 (45.7) | 21 (60.0) |
| ECOG performance score, N (%) | ||
| 0 | 26 (74.3) | 28 (80.0) |
| 1 or 2 | 9 (25.7) | 7 (20.0) |
| Months from diagnosis to on study, median (range) | 65.4 (17.8-268.4) | 45.8 (7.2-175.8) |
| Cytogenetic risk | ||
| High (del 17p, t(4;14), t(14;16)) | 5 (14.3%) | 5 (14.3%) |
| Standard | 30 (85.7%) | 30 (85.7%) |
| Number of prior planned regimens, median (range) | 4 (2-8) | 4 (2-5) |
| Prior therapies, N (%) | ||
| Alkylators | 25 (71.4) | 27 (77.1) |
| Thalidomide | 5 (15.6) | 6 (19.4) |
| Lenalidomide | 27 (84.4) | 28 (90.3) |
| Pomalidomide | 5 (15.6) | 5 (16.1) |
| Bortezomib | 9 (25.7) | 12 (34.3) |
| Previous transplant, N (%) | 24 (68.6) | 26 (74.3) |
| Refractory to lenalidomide, N (%) | 16 (45.7) | 16 (45.7) |
| Bortezomib or carfilzomib exposure, limited, N (%) | 11 (31.4) | 12 (34.3) |
| . | Arm B (4 mg) (N = 35) . | Arm C (5.5 mg) (N = 35) . |
|---|---|---|
| Age, median (range) | 71.0 (46.0-83.0) | 69.0 (51.0-84.0) |
| Male, N (%) | 16 (45.7) | 21 (60.0) |
| ECOG performance score, N (%) | ||
| 0 | 26 (74.3) | 28 (80.0) |
| 1 or 2 | 9 (25.7) | 7 (20.0) |
| Months from diagnosis to on study, median (range) | 65.4 (17.8-268.4) | 45.8 (7.2-175.8) |
| Cytogenetic risk | ||
| High (del 17p, t(4;14), t(14;16)) | 5 (14.3%) | 5 (14.3%) |
| Standard | 30 (85.7%) | 30 (85.7%) |
| Number of prior planned regimens, median (range) | 4 (2-8) | 4 (2-5) |
| Prior therapies, N (%) | ||
| Alkylators | 25 (71.4) | 27 (77.1) |
| Thalidomide | 5 (15.6) | 6 (19.4) |
| Lenalidomide | 27 (84.4) | 28 (90.3) |
| Pomalidomide | 5 (15.6) | 5 (16.1) |
| Bortezomib | 9 (25.7) | 12 (34.3) |
| Previous transplant, N (%) | 24 (68.6) | 26 (74.3) |
| Refractory to lenalidomide, N (%) | 16 (45.7) | 16 (45.7) |
| Bortezomib or carfilzomib exposure, limited, N (%) | 11 (31.4) | 12 (34.3) |
ECOG, Eastern Cooperative Oncology Group.