Table 5.

ORR per IMWG 2011 criteria by time points of interest (ITT population)

Time pointORR (N = 25), n (%)95% Clopper-Pearson CI
Day 4220 (80)0.59-0.93
Day 100*19 (76)0.55-0.91
Day 18016 (64)0.43-0.82
Day 27013 (52)0.31-0.72
Year 111 (44)0.24-0.65
  • ORR is defined as the proportion of patients who have a positive response by IMWG 2011 criteria (sCR, CR, VGPR, PR) relative to the total number of patients in the population.

  • CR, complete response; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.

  • * Day 100 responders (n = 19): 1 sCR, 12 VGPR, and 6 PR.

  • Year 1 responders (n = 11): 1 sCR, 1 CR, 8 VGPR, and 1 PR.