SELIBORDARA: Selinexor, Bortezomib and Daratumumab in Multiple Myeloma

Phase 2, single-arm, open, non-randomized, multicenter study of the SINE™ compound selinexor plus low-dose dexamethasone, in combination with bortezomib and daratumumab. 100 mg selinexor (on days 1, 8, 15 and 22), plus 40 mg dexamethasone (20 mg IV the day of daratumumab and selinexor and 20 mg oral administration the day after daratumumab and selinexor) both weekly as continuous therapy. Bortezomib will be given via subcutaneous at dose of 1.3 mg/m2 once weekly on days 1, 8, 15 and 22 during the cycles 1 to cycle 8, and on day 1 and day 15 of each cycle thereafter as continuous therapy. Daratumumab will be given via intravenous at dose of 16 mg/Kg on days 1, 8, 15 and 22 (weekly) during the cycles 1 and 2, every two weeks (on days 1 and 15) during the cycles 3 to 6 and on day 1 of each cycle thereafter as continuous therapy. Patients may continue indefinitely and there is no maximum treatment duration

NCT Number	NCT03589222
Lead Sponsor	PETHEMA Foundation
Conditions	Refractory Multiple Myeloma
Enrollment	62 participants
Start Date	2018-07-15
Primary Completion	2026-08 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-02-27