Table 2.
Patient demographics and disease characteristics (phase 1 and 2).
| Characteristic | 5/14 schedule 150–210 mg/day OPZ (n = 19) |
2/7 schedule 210–330 mg/day OPZ (n = 46) |
|---|---|---|
| Age, years | ||
| Median (range) | 64.0 (50–92) | 65.0 (45–87) |
| Age group, n (%) | ||
| < 65 years | 11 (57.9) | 22 (47.8) |
| 65 to < 75 years | 5 (26.3) | 15 (32.6) |
| ≥ 75 years | 3 (15.8) | 9 (19.6) |
| Sex, n (%) | ||
| Male | 11 (57.9) | 27 (58.7) |
| Race, n (%) | ||
| White | 17 (89.5) | 30 (65.2) |
| Black | 1 (5.3) | 7 (15.2) |
| Asian | 1 (5.3) | 0 |
| Other | 0 | 2 (4.3) |
| Not reported | 0 | 7 (15.2) |
| ECOG performance status, n (%) | ||
| 0 | 11 (57.9) | 28 (60.9) |
| 1 | 7 (36.8) | 18 (39.1) |
| 2 | 1 (5.3) | 0 |
| ISS stage at initial diagnosis, n (%) | ||
| 1 | 4 (21.1) | 11 (23.9) |
| 2 | 8 (42.1) | 18 (39.1) |
| 3 | 6 (31.6) | 9 (19.6) |
| Unknown | 1 (5.3) | 8 (17.4) |
| Time from initial diagnosis to first dose, years | ||
| Mean | 4.6 | 5.4 |
| Prior therapies | ||
| Number of prior therapies | ||
| Median | 2 (1–5) | 2 (1–5) |
| Exposure to prior therapies, n (%) | ||
| Bortezomib | 19 (100) | 41 (89.1) |
| Carfilzomib | 0 | 0 |
| Lenalidomide | 19 (100) | 42 (91.3) |
| Prior transplant, n (%) | 12 (63.2) | 27 (58.7) |
| No. of patients grouped by total no. of prior therapies, n (%) | ||
| 1 | 2 (10.5) | 9 (19.6) |
| 2 | 12 (63.2) | 15 (32.6) |
| ≥ 3 | 5 (26.3) | 22 (47.8) |
| Patients with refractory MM, n (%) | ||
| Refractory to bortezomib | 10 (52.6) | 28 (60.9) |
| Refractory to bortezomib or immunomodulatory agents in any prior regimena | 14 (73.6) | 36 (78.3) |
| Refractory to last regimen, n (%) | 14 (73.6) | 31 (67.4) |
| Refractory to bortezomib in last prior regimen | 7 (36.8) | 18 (39.1) |
ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; OPZ, oprozomib.
a
Includes lenalidomide, thalidomide, pomalidomide, and immunomodulatory agents.