Treatment responses in the intention-to-treat population (determined by the sponsor using ORCA)
| Variable . | Carfilzomib group (n = 478) . | Bortezomib group (n = 477) . | P (1-sided) . |
|---|---|---|---|
| Best response, no. (%)* | |||
| sCR | 13 (2.7) | 10 (2.1) | |
| CR | 111 (23.2) | 100 (21.0) | |
| Very good PR | 169 (35.4) | 125 (26.2) | |
| PR | 110 (23.0) | 141 (29.6) | |
| Stable disease | 50 (10.5) | 75 (15.7) | |
| Progressive disease | 3 (0.6) | 3 (0.6) | |
| Not evaluable | 22 (4.6) | 23 (4.8) | |
| CR or better, % (95% CI) | 25.9 (22.1-30.1) | 23.1 (19.4-27.1) | |
| OR, carfilzomib group/bortezomib group (95% CI) | 1.179 (0.875-1.589) | .14 | |
| ORR, % (95% CI)† | 84.3 (80.7-87.5) | 78.8 (74.9-82.4) | |
| OR, carfilzomib group/bortezomib group (95% CI) | 1.412 (1.010-1.973) | .02 | |
| Duration of response, mo | |||
| Median | 25.2 | 22.8 | |
| 95% CI | 21.3-NE | 20.2-25.8 | |
| Variable . | Carfilzomib group (n = 478) . | Bortezomib group (n = 477) . | P (1-sided) . |
|---|---|---|---|
| Best response, no. (%)* | |||
| sCR | 13 (2.7) | 10 (2.1) | |
| CR | 111 (23.2) | 100 (21.0) | |
| Very good PR | 169 (35.4) | 125 (26.2) | |
| PR | 110 (23.0) | 141 (29.6) | |
| Stable disease | 50 (10.5) | 75 (15.7) | |
| Progressive disease | 3 (0.6) | 3 (0.6) | |
| Not evaluable | 22 (4.6) | 23 (4.8) | |
| CR or better, % (95% CI) | 25.9 (22.1-30.1) | 23.1 (19.4-27.1) | |
| OR, carfilzomib group/bortezomib group (95% CI) | 1.179 (0.875-1.589) | .14 | |
| ORR, % (95% CI)† | 84.3 (80.7-87.5) | 78.8 (74.9-82.4) | |
| OR, carfilzomib group/bortezomib group (95% CI) | 1.412 (1.010-1.973) | .02 | |
| Duration of response, mo | |||
| Median | 25.2 | 22.8 | |
| 95% CI | 21.3-NE | 20.2-25.8 | |
Treatment responses were assessed by the sponsor using ORCA.
An sCR was defined by a negative immunofixation test for myeloma protein in urine and the disappearance of any soft tissue plasmacytomas, with <5% plasma cells in bone marrow, a normal serum free light chain ratio, and an absence of clonal cells in the bone marrow. See the supplemental Table 1 for definitions of “complete response,” “very good partial response,” “partial response,” “minimal response,” “stable disease,” and “progressive disease.”
Overall response was defined as a PR or better.