Treatment-related AEs occurring in ≥10% of patients
| AE term . | All patients (n = 42) . | Dose escalation patients (n = 16) . | RP2D patients (n = 26) . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All doses, n (%) . | 60, 80 mg selinexor QW/BIW + 1.3 mg/m2 bortezomib QW/BIW, n (%) . | 100 mg selinexor QW + 1.3 mg/m2 bortezomib QW, n (%) . | |||||||||||||
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Nausea | 7 (17) | 17 (40) | 2 (5) | — | 26 (62) | 2 (13) | 3 (19) | 2 (13) | — | 7 (44) | 5 (19) | 14 (54) | — | — | 19 (73) |
| Fatigue | 3 (7) | 16 (38) | 6 (14) | — | 25 (60) | — | 9 (56) | — | — | 9 (56) | 3 (12) | 7 (27) | 6 (23) | — | 16 (62) |
| Decreased appetite | 13 (31) | 11 (26) | 1 (2) | — | 25 (60) | 5 (31) | 3 (19) | 1 (6) | — | 9 (56) | 8 (31) | 8 (31) | — | — | 16 (62) |
| Thrombocytopenia | — | 2 (5) | 7 (17) | 12 (29) | 21 (50) | — | 1 (6) | 4 (25) | 7 (44) | 12 (75) | — | 1 (4) | 3 (12) | 5 (19) | 9 (35) |
| Diarrhea | 11 (26) | 4 (10) | 3 (7) | — | 18 (43) | 4 (25) | 3 (19) | 2 (13) | — | 9 (56) | 7 (27) | 1 (4) | 1 (4) | — | 9 (35) |
| Vomiting | 9 (21) | 3 (7) | 1 (2) | — | 13 (31) | 2 (13) | 2 (13) | 1 (6) | — | 5 (31) | 7 (27) | 1 (4) | — | — | 8 (31) |
| Neutropenia | 1 (2) | — | 9 (21) | 1 (2) | 11 (26) | — | — | 4 (25) | 1 (6) | 5 (31) | 1 (4) | — | 5 (19) | — | 6 (23) |
| Anemia | 1 (2) | 2 (5) | 5 (12) | — | 8 (19) | — | 1 (6) | 4 (25) | — | 5 (31) | 1 (4) | 1 (4) | 1 (4) | — | 3 (12) |
| Weight decreased | 2 (5) | 6 (14) | — | — | 8 (19) | 1 (6) | 4 (25) | — | — | 5 (31) | 1 (4) | 2 (8) | — | — | 3 (12) |
| Blurred vision | 6 (14) | 2 (5) | — | — | 8 (19) | 2 (13) | — | — | — | 2 (13) | 4 (15) | 2 (8) | — | — | 6 (23) |
| Altered taste | 5 (12) | 1 (2) | — | — | 6 (14) | 2 (13) | — | — | — | 2 (13) | 3 (12) | 1 (4) | — | — | 4 (15) |
| Dehydration | — | 5 (12) | — | — | 5 (12) | — | 2 (13) | — | — | 2 (13) | — | 3 (12) | — | — | 3 (12) |
| Cataract | — | 5 (12) | — | — | 5 (12) | — | 3 (19) | — | — | 3 (19) | — | 2 (8) | — | — | 2 (8) |
| Confusion | 1 (2) | 3 (7) | 1 (2) | — | 5 (12) | — | 1 (6) | 1 (6) | — | 2 (13) | 1 (4) | 2 (8) | — | — | 3 (12) |
| Peripheral edema | 4 (10) | 1 (2) | — | — | 5 (12) | 3 (19) | — | — | — | 3 (19) | 1 (4) | 1 (4) | — | — | 2 (8) |
| Hyponatremia | 2 (5) | — | 2 (5) | — | 4 (10) | 1 (6) | — | 1 (6) | — | 2 (13) | 1 (4) | — | 1 (4) | — | 2 (8) |
| Peripheral neuropathy* | 2 (5) | 2 (5) | — | — | 4 (10) | 2 (13) | 1 (6) | — | — | 3 (19) | — | 1 (4) | — | — | 1 (4) |
| AE term . | All patients (n = 42) . | Dose escalation patients (n = 16) . | RP2D patients (n = 26) . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All doses, n (%) . | 60, 80 mg selinexor QW/BIW + 1.3 mg/m2 bortezomib QW/BIW, n (%) . | 100 mg selinexor QW + 1.3 mg/m2 bortezomib QW, n (%) . | |||||||||||||
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Nausea | 7 (17) | 17 (40) | 2 (5) | — | 26 (62) | 2 (13) | 3 (19) | 2 (13) | — | 7 (44) | 5 (19) | 14 (54) | — | — | 19 (73) |
| Fatigue | 3 (7) | 16 (38) | 6 (14) | — | 25 (60) | — | 9 (56) | — | — | 9 (56) | 3 (12) | 7 (27) | 6 (23) | — | 16 (62) |
| Decreased appetite | 13 (31) | 11 (26) | 1 (2) | — | 25 (60) | 5 (31) | 3 (19) | 1 (6) | — | 9 (56) | 8 (31) | 8 (31) | — | — | 16 (62) |
| Thrombocytopenia | — | 2 (5) | 7 (17) | 12 (29) | 21 (50) | — | 1 (6) | 4 (25) | 7 (44) | 12 (75) | — | 1 (4) | 3 (12) | 5 (19) | 9 (35) |
| Diarrhea | 11 (26) | 4 (10) | 3 (7) | — | 18 (43) | 4 (25) | 3 (19) | 2 (13) | — | 9 (56) | 7 (27) | 1 (4) | 1 (4) | — | 9 (35) |
| Vomiting | 9 (21) | 3 (7) | 1 (2) | — | 13 (31) | 2 (13) | 2 (13) | 1 (6) | — | 5 (31) | 7 (27) | 1 (4) | — | — | 8 (31) |
| Neutropenia | 1 (2) | — | 9 (21) | 1 (2) | 11 (26) | — | — | 4 (25) | 1 (6) | 5 (31) | 1 (4) | — | 5 (19) | — | 6 (23) |
| Anemia | 1 (2) | 2 (5) | 5 (12) | — | 8 (19) | — | 1 (6) | 4 (25) | — | 5 (31) | 1 (4) | 1 (4) | 1 (4) | — | 3 (12) |
| Weight decreased | 2 (5) | 6 (14) | — | — | 8 (19) | 1 (6) | 4 (25) | — | — | 5 (31) | 1 (4) | 2 (8) | — | — | 3 (12) |
| Blurred vision | 6 (14) | 2 (5) | — | — | 8 (19) | 2 (13) | — | — | — | 2 (13) | 4 (15) | 2 (8) | — | — | 6 (23) |
| Altered taste | 5 (12) | 1 (2) | — | — | 6 (14) | 2 (13) | — | — | — | 2 (13) | 3 (12) | 1 (4) | — | — | 4 (15) |
| Dehydration | — | 5 (12) | — | — | 5 (12) | — | 2 (13) | — | — | 2 (13) | — | 3 (12) | — | — | 3 (12) |
| Cataract | — | 5 (12) | — | — | 5 (12) | — | 3 (19) | — | — | 3 (19) | — | 2 (8) | — | — | 2 (8) |
| Confusion | 1 (2) | 3 (7) | 1 (2) | — | 5 (12) | — | 1 (6) | 1 (6) | — | 2 (13) | 1 (4) | 2 (8) | — | — | 3 (12) |
| Peripheral edema | 4 (10) | 1 (2) | — | — | 5 (12) | 3 (19) | — | — | — | 3 (19) | 1 (4) | 1 (4) | — | — | 2 (8) |
| Hyponatremia | 2 (5) | — | 2 (5) | — | 4 (10) | 1 (6) | — | 1 (6) | — | 2 (13) | 1 (4) | — | 1 (4) | — | 2 (8) |
| Peripheral neuropathy* | 2 (5) | 2 (5) | — | — | 4 (10) | 2 (13) | 1 (6) | — | — | 3 (19) | — | 1 (4) | — | — | 1 (4) |
Treatment-related treatment emergent AEs occurring in ≥10% of patients (n = 42). A subject with an AE coding to the same System Organ Class or Preferred Term on >1 occasion is only counted once for the System Organ Class and Preferred Term at the highest grade. Dashes (—) indicate no event occurred.
BIW, twice weekly; QW, once weekly.
Includes the terms peripheral neuropathy, peripheral sensory neuropathy, sensory neuropathy, and hypoesthesia. Neuralgia, decreased vibratory sense, polyneuropathy, sensory loss, amyotrophy, peripheral motor neuropathy, peripheral sensorimotor neuropathy, sensory disturbance, and toxic neuropathy were not reported in this study.