Table 1 Treatment schedule, dose levels and DLTs.
Dose levels | Selinexor, days 1, 8, 15 and 22 | Dexamethasone, days 1, 8, 15 and 22 | Carfilzomib, days 1, 8, and 15 | Patients enrolled | Patients DLT evaluable | Patients with DLT | DLTs |
---|---|---|---|---|---|---|---|
1 | 100 mg PO | 40 mg IV or PO | 56 mg/m2 IV | 3 | 2a | 2b | Selinexor dose reduction due to Grade 3 thrombocytopenia; selinexor dose reduction due to Grade 3 vomiting |
−1 | 80 mg PO | 40 mg IV or PO | 56 mg/m2 IV | 6 | 6c | 0 | No DLTs |
−1a | 80 mg PO | 40 mg IV or PO | 70 mg/m2 IV | 3 | 3 | 2c | Grade 4 thrombocytopenia and Grade 3 pneumonia; Grade 4 thrombocytopenia |
−1b | 60 mg PO | 40 mg IV or PO | 70 mg/m2 IV | 3 | ND | ND | ND |
n1 | 100 mg PO—not on Day 22 | 40 mg IV or PO | 56 mg/m2 IV | 2 | ND | ND | ND |
n−1 | 80 mg PO—not on Day 22 | 40 mg IV or PO | 70 mg/m2 IV | 3 | ND | ND | ND |