Summary of response to treatment in the total study population and per group (n = 50)
| . | Total . | del(17p) . | t(4;14) . |
|---|---|---|---|
| Response rate, ITT (n = 50), n (%) | |||
| ORR (≥PR) | 11 (22) | 7 (32) | 5 (15) |
| ≥VGPR | 3 (6) | 2 (9) | 1 (3) |
| PR | 8 (16) | 5 (23) | 4 (12) |
| Stable disease | 30 (60) | 9 (41) | 22 (69) |
| CBR (≥MR) | 17 (34) | 7 (32) | 11 (34) |
| Progressive disease | 7 (14) | 4 (18) | 5 (15) |
| Not evaluable | 2 (4) | 2 (9) | 0 |
| Time to first response, mo | |||
| Median (95% CI) | 4.1 (4;8) | — | — |
| Range | 3-28 | — | — |
| Duration of response, mo | |||
| Median (95% CI) | 5.5 (0.95;–) | 8.3 (1.9;–) | 2.4 (0.95;8.3) |
| One-year free, % | 44 | 67 | 25 |
| Response rate, EE (n = 47), n (%) | |||
| ORR | 11 (23) | — | — |
| CBR | 17 (36) | — | — |
| . | Total . | del(17p) . | t(4;14) . |
|---|---|---|---|
| Response rate, ITT (n = 50), n (%) | |||
| ORR (≥PR) | 11 (22) | 7 (32) | 5 (15) |
| ≥VGPR | 3 (6) | 2 (9) | 1 (3) |
| PR | 8 (16) | 5 (23) | 4 (12) |
| Stable disease | 30 (60) | 9 (41) | 22 (69) |
| CBR (≥MR) | 17 (34) | 7 (32) | 11 (34) |
| Progressive disease | 7 (14) | 4 (18) | 5 (15) |
| Not evaluable | 2 (4) | 2 (9) | 0 |
| Time to first response, mo | |||
| Median (95% CI) | 4.1 (4;8) | — | — |
| Range | 3-28 | — | — |
| Duration of response, mo | |||
| Median (95% CI) | 5.5 (0.95;–) | 8.3 (1.9;–) | 2.4 (0.95;8.3) |
| One-year free, % | 44 | 67 | 25 |
| Response rate, EE (n = 47), n (%) | |||
| ORR | 11 (23) | — | — |
| CBR | 17 (36) | — | — |
The median time to first response and response duration are also provided.
CBR, clinical benefit rate; EE, efficacy evaluable; MR, minor response; PR, partial response.