Introduction
Patients and methods
Results
AE, n (%) | Ixazomib (n = 394) | Placebo (n = 259) | ||||||
---|---|---|---|---|---|---|---|---|
Any grade | Grade ≥ 3 | SAE | D/C | Any grade | Grade ≥ 3 | SAE | D/C | |
Hematologic AEs | ||||||||
Thrombocytopeniaa | 53 (13) | 19 (5) | 1 (< 1) | 2 (< 1) | 8 (3) | 2 (< 1) | 1 (< 1) | 0 |
Neutropeniaa | 36 (9) | 20 (5) | 0 | 0 | 20 (8) | 9 (3) | 0 | 0 |
Anemia | 29 (7) | 4 (1) | 0 | 0 | 10 (4) | 2 (< 1) | 1 (< 1) | 0 |
Non-hematologic AEs | ||||||||
Infections and infestations | ||||||||
Upper RTI | 101 (26) | 2 (< 1) | 2 (< 1) | 0 | 54 (21) | 1 (< 1) | 0 | 0 |
Viral upper RTI | 94 (24) | 0 | 0 | 0 | 69 (27) | 0 | 1 (< 1) | 0 |
Gastrointestinal AEs | ||||||||
Nausea | 154 (39) | 1 (< 1) | 0 | 0 | 40 (15) | 0 | 0 | 0 |
Diarrhea | 137 (35) | 10 (3) | 4 (1) | 1 (< 1) | 61 (24) | 2 (< 1) | 0 | 0 |
Vomiting | 106 (27) | 6 (2) | 1 (< 1) | 0 | 28 (11) | 0 | 0 | 0 |
Rasha | 120 (30) | 7 (2) | 2 (< 1) | 2 (< 1) | 57 (22) | 0 | 0 | 0 |
AEs of clinical interest | ||||||||
PNa | 73 (19) | 1 (< 1) | 0 | 2 (< 1) | 39 (15) | 0 | 0 | 2 (< 1) |
Thromboembolic AEs | ||||||||
Venous | 2 (< 1) | 0 | 1 (< 1) | 1 (< 1) | 0 | 0 | 0 | 0 |
Arterial | 1 (< 1) | 0 | 0 | 0 | 3 (1) | 1 (< 1) | 2 (< 1) | 0 |
Pneumoniab | 40 (10) | 25 (6)b | 24 (6) | 2 (< 1) | 21 (8) | 11 (4) | 10 (4) | 0 |
Herpes zoster | 39 (10) | 3 (< 1) | 4 (1) | 0 | 14 (5) | 3 (1) | 2 (< 1) | 0 |
Thrombocytopenia
Neutropenia
Gastrointestinal toxicities
Peripheral neuropathy
Ixazomib (n = 394) | Placebo (n = 259) | |
---|---|---|
PN incidence by grade, n (%) | ||
Grade 1 | 55 (14) | 24 (9) |
Grade 2 | 17 (4) | 15 (6) |
Grade 3 | 1 (< 1) | 0 |
PN incidence by prior therapy or baseline PN, n/N (%) | ||
Prior PI therapy, yes versus no | 61/351 (17) versus 12/43 (28) | 36/232 (16) versus 3/27 (11) |
Prior thalidomide, yes versus no | 33/141 (23) versus 40/253 (16) | 14/101 (14) versus 25/158 (16) |
PN at study entry, yes versus no | 8/44 (18) versus 65/350 (19) | 12/38 (32) versus 27/221 (12) |
Dose reductions due to PN, n (%) | 10 (3) | 5 (2) |
Discontinuations due to PN, n (%) | 2 (< 1) | 2 (< 1) |
PN—number of individual events, n | 94 | 43 |
Improved, n (%) | 70 (74) | 31 (72) |
Median time to improvement (days) | 134 | 130 |
Resolved, n (%) | 66 (70) | 28 (65) |
Median time to resolution (days) | 225 | 159 |