At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 202 enrolled
Drug / intervention
Selinexor +1 moredrug
Likely dose
Selinexor 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab
In Brief
A Phase 2 clinical trial evaluating Selinexor and Dexamethasone for Multiple Myeloma. Completed, enrolled 202 participants across 61 sites in 6 countries.
Detailed Summary
This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesAustria, Belgium, France, Germany, Greece, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMay 2015
Primary CompletionJul 2019
TodayJul 2026
First PostedJan 13, 2015
Enrollment StartMay 26, 2015
Primary CompletionJul 26, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.5 years ago
Interventions
Selinexordrug
Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.)
Dexamethasonedrug
20 mg was given with each dose of Selinexor.