International Myeloma Working Group best response on treatment per study arm
| Response . | Arm A (N = 10) [N (%)] . | Arm B (N = 36) [N (%)] . | Arm C (N = 34) [N (%)] . | Arm D (N = 17) [N (%)] . |
|---|---|---|---|---|
| Complete/stringent complete response | 1 (10) | 1 (3%) | 1 (3) | |
| Very good partial response | 1 (10) | 4 (11) | 3 (9) | |
| Partial response | 3 (30) | 9 (25) | 18 (53) | 1 (6) |
| Minimal response | 2 (20) | 8 (22) | 5 (15) | 4 (23) |
| Stable disease | 2 (20) | 7 (19) | 1 (3) | 8 (47) |
| Progressive disease | 1 (10) | 5 (14) | 3 (9) | 4 (23) |
| Not evaluable* | 2 (6) | 3 (9) | ||
| Overall response rate (≥PR)† | 14 (39) | 22 (65) | 1 (6) |
| Response . | Arm A (N = 10) [N (%)] . | Arm B (N = 36) [N (%)] . | Arm C (N = 34) [N (%)] . | Arm D (N = 17) [N (%)] . |
|---|---|---|---|---|
| Complete/stringent complete response | 1 (10) | 1 (3%) | 1 (3) | |
| Very good partial response | 1 (10) | 4 (11) | 3 (9) | |
| Partial response | 3 (30) | 9 (25) | 18 (53) | 1 (6) |
| Minimal response | 2 (20) | 8 (22) | 5 (15) | 4 (23) |
| Stable disease | 2 (20) | 7 (19) | 1 (3) | 8 (47) |
| Progressive disease | 1 (10) | 5 (14) | 3 (9) | 4 (23) |
| Not evaluable* | 2 (6) | 3 (9) | ||
| Overall response rate (≥PR)† | 14 (39) | 22 (65) | 1 (6) |
Two patients were randomized but did not receive study therapy and were included as treatment failure (one was randomized to arm B and the other to arm C). In addition, 3 patients did not complete a cycle of therapy and return for disease assessment and are included as not evaluable (treatment failure based on intent to treat).
The ORR (PR or better) for arm C was 64.7% (95% CI, 48.6-80.8), whereas the ORR for arm B was 38.9% (95% CI, 23-54.8; P = .035).