Table 1.

Best overall response by blinded independent central review

Cohort 1 (n = 69): after ASCT/BVCohort 2 (n = 81): ineligible for ASCT and treatment failure with BV therapyCohort 3 (n = 60): no BV after ASCTAll 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 
Cohort 1 (n = 69): after ASCT/BVCohort 2 (n = 81): ineligible for ASCT and treatment failure with BV therapyCohort 3 (n = 60): no BV after ASCTAll 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.

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