Table 3 Treatment exposure and overall safety profile with ixa-dex and pom-dex in the safety population.

From: Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial

 

Ixa-dex n = 72

Pom-dex n = 47

Treatment exposure

Median number of treatment cycles received, n (range)

6 (1–25)

6 (1–27)

 Median time on treatment at ixa 5.5 mg, months (range)

n = 46 1.8 (<1–17)

 

Patients receiving ≥7 cycles, n (%)

35 (49)

21 (45)

Patients receiving ≥19 cycles, n (%)

5 (7)

7 (15)

Mean (StD) relative dose intensity, %

 Ixazomib / Pomalidomide

79.5 (15.02)

89.9 (13.31)

 Dexamethasone

84.0 (16.62)

87.8 (15.57)

Safety profile

 Any TEAE, n (%)

70 (97)

47 (100)

 Any drug-related TEAE, n (%)

64 (89)

39 (83)

 Any Grade ≥3 TEAE, n (%)

50 (69)

38 (81)

 Any drug-related Grade ≥3 TEAE, n (%)

35 (49)

31 (66)

 Any serious TEAE, n (%)

37 (51)

25 (53)

 Any drug-related serious TEAE, n (%)

16 (22)

13 (28)

 TEAE resulting in dose reduction of ≥1 of the 2 agents in the study drug regimen, n (%)

32 (44)

15 (32)

 TEAE resulting in discontinuation of ≥1 of the 2 agents in the study drug regimen, n (%)

28 (39)

17 (36)

 On-study deaths, n (%)

9 (13)

6 (13)

  1. Dex dexamethasone, ixa ixazomib, pom pomalidomide, StD standard deviation, TEAE treatment-emergent adverse event.
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