| Selvedex trial Open label fase II studie | (Inclusie in overleg met research-verpleegk. Erasmus MC hematologie) |
Inclusie
- Progressief of refractair symptomatisch Multipel Myeloom
- Minimaal 1 voorgaande behandeling
Exclusie
- Prior resistance/refractory disease to bortezomib
Target number of patients:
Part I: 6 patients per dose level of selinexor (MTD)
Part II: 31 patients (efficacy)
Behandeling:
4 cycli selinexor, bortezomib en dexamethason. Cyclus is 28 dagen
HDM/ASCT (indien niet eerder gehad)
4 cycli selinexor, bortezomib en dexamethason.
| *20mg Dexamethasone can also be administered on days 1,2,8,9,15,16,22,23 | |||
| Agent | Dose/day | Route of administration | Days |
|---|---|---|---|
| Selinexor | 45, 40, 30 or 20 mg/m² | orally | 1, 8, 15, 22 |
| Bortexomib | 1.3 mg/m² | subcutaneously | 1, 8, |
| Dexamethasone* | 40 mg | orally | 1, 8, 15, 22 |