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Table 2 Summary of best confirmed response to treatment with ixazomib-Rd and placebo-Rd

From: Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study

Best confirmed response, n (%)

Ixazomib-Rd (n = 57)

Placebo-Rd (n = 58)

p value (unstratified Cochran–Mantel–Haenszel test)

ORR (≥PR) (95% CI)

32 (56) (42–69)

18 (31) (20–45)

0.007

 ≥VGPR rate (95% CI)

14 (25) (14–38)

7 (12) (5–23)

0.084

CR

3 (5)

0

0.078

PR

29 (51)

18 (31)

–

 VGPR

11 (19)

7 (12)

–

SD

17 (30)

17 (29)

–

PD

6 (11)

15 (26)

–

Not evaluable

2 (4)

8 (14)

–

 

n = 32

n = 18

 

Time to response, median (IQR)

1.0 (0.9–1.8)

1.0 (0.9–1.9)

–

DOR, median (95% CI)

7.4 months (6.21–NE)

5.6 months (2.73–9.46)

–

Responders who had not progressed at data cut-off, n (%)

19 (59)

7 (39)

 
  1. Time to response: time from first documentation of PR or better to first documentation of PD; Duration of response: time from first documentation of partial response or better to first documentation of progression
  2. Abbreviations: CR complete response, DOR duration of response, NE not estimable, ORR overall response rate, PD progressive disease, PR partial response, SD stable disease, VGPR very good partial response