Table 1.
Best overall response by blinded independent central review
| Cohort 1 (n = 69): after ASCT/BV | Cohort 2 (n = 81): ineligible for ASCT and treatment failure with BV therapy | Cohort 3 (n = 60): no BV after ASCT | All patients (N = 210) | |||||
|---|---|---|---|---|---|---|---|---|
| n (%) | 95% CI* | n (%) | 95% CI* | n (%) | 95% CI* | n (%) | 95% CI* | |
| ORR | 53 (76.8) | 65.1-86.1 | 54 (66.7) | 55.3-76.8 | 44 (73.3) | 60.3-83.9 | 151 (71.9) | 65.3-77.9 |
| CR† | 18 (26.1) | 16.3-38.1 | 21 (25.9) | 16.8-36.9 | 19 (31.7) | 20.3-45.0 | 58 (27.6) | 21.7-34.2 |
| PR | 35 (50.7) | 38.4-63.0 | 33 (40.7) | 29.9-52.2 | 25 (41.7) | 29.1-55.1 | 93 (44.3) | 37.5-51.3 |
| SD | 9 (13.0) | 6.1-23.3 | 7 (8.6) | 3.5-17.0 | 7 (11.7) | 4.8-22.6 | 23 (11.0) | 7.1-16.0 |
| PD | 5 (7.2) | 2.4-16.1 | 18 (22.2) | 13.7-32.8 | 9 (15.0) | 7.1-26.6 | 32 (15.2) | 10.7-20.8 |
| No assessment | 2 (2.9) | 0.4-10.1 | 2 (2.5) | 0.3-8.6 | 0 (0) | — | 4 (1.9) | 0.5-4.8 |
*
Based on binomial exact CI method.
†
For complete remission, a residual mass was permitted for patients who had negative results, as seen on positron emission tomography.