Dose and treatment schedules
| Schedule . | Selinexor dose . | Selinexor doses per cycle . | Patients with MM or WM (n) . |
|---|---|---|---|
| Days 1, 3, and 5 of weeks 1 and 3; Days 1 and 3 of weeks 2 and 4 | 3 mg/m2 | 10 | 1 |
| 6 mg/m2 | 10 | 2 | |
| 12 mg/m2 | 10 | 2 | |
| Lead-in week, 12 mg/m2; Days 1, 3, and 5 of weeks 1 and 3; Days 1 and 3 of weeks 2 and 4 | 16.8 mg/m2 | 10 | 5 |
| 23 mg/m2 | 10 | 5 | |
| 30 mg/m2 | 10 | 1 | |
| Twice weekly (includes days 1 and 2, 1 and 3, 1 and 4) | 23 mg/m2 | 8 | 2 |
| 30 mg/m2 | 8 | 1 | |
| 35 mg/m2 | 8 | 14 | |
| 45 mg/m2 | 8 | 10 | |
| 45 mg/m2 (+20 mg dex) | 8 | 12 | |
| 55 mg/m2 | 8 | 1 | |
| 60 mg/m2 | 8 | 2 | |
| 60 mg/m2 (+20 mg dex) | 8 | 15 | |
| Days 1 and 3 for 3 weeks; 1-week holiday; no corticosteroids allowed | 40 mg | 6 | 10 |
| 60 mg | 6 | 1 | |
| Total | — | — | 84 |
| Schedule . | Selinexor dose . | Selinexor doses per cycle . | Patients with MM or WM (n) . |
|---|---|---|---|
| Days 1, 3, and 5 of weeks 1 and 3; Days 1 and 3 of weeks 2 and 4 | 3 mg/m2 | 10 | 1 |
| 6 mg/m2 | 10 | 2 | |
| 12 mg/m2 | 10 | 2 | |
| Lead-in week, 12 mg/m2; Days 1, 3, and 5 of weeks 1 and 3; Days 1 and 3 of weeks 2 and 4 | 16.8 mg/m2 | 10 | 5 |
| 23 mg/m2 | 10 | 5 | |
| 30 mg/m2 | 10 | 1 | |
| Twice weekly (includes days 1 and 2, 1 and 3, 1 and 4) | 23 mg/m2 | 8 | 2 |
| 30 mg/m2 | 8 | 1 | |
| 35 mg/m2 | 8 | 14 | |
| 45 mg/m2 | 8 | 10 | |
| 45 mg/m2 (+20 mg dex) | 8 | 12 | |
| 55 mg/m2 | 8 | 1 | |
| 60 mg/m2 | 8 | 2 | |
| 60 mg/m2 (+20 mg dex) | 8 | 15 | |
| Days 1 and 3 for 3 weeks; 1-week holiday; no corticosteroids allowed | 40 mg | 6 | 10 |
| 60 mg | 6 | 1 | |
| Total | — | — | 84 |
Selinexor dose level and schedule for the subset of patients with multiple myeloma (n = 81) or WM (n = 3) in the NCT01607892 study (n = 285). Dose escalation for the study followed a standard 3+3 design and included patients with a spectrum of hematological malignancies. Dose expansion cohorts were tested at 35, 45, 45, and 60 mg/m2 plus dexamethasone, as well as 40 and 60 mg flat dose without corticosteroids to better understand tolerability and efficacy.
Dex, dexamethasone.