|
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)
| |
- 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
-
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
