Selinexor and Backbone Treatments of Multiple Myeloma Patients

Official Title

A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma

Summary:

This study will independently assess the efficacy and safety of six combination therapies for the treatment of patients with Relapsed/Refractory Multiple Myeloma (RR MM) and Newly Diagnosed Multiple Myeloma (NDMM). The combinations to be evaluated include: selinexor + pomalidomide + dexamethasone (SPd), selinexor + bortezomib + dexamethasone (SVd), selinexor + lenalidomide + dexamethasone (SRd), selinexor + pomalidomide + dexamethasone + bortezomib (SPVd), selinexor + daratumumab + dexamethasone (SDd), and selinexor + carfilzomib + dexamethasone (SKd). The abbreviations for combination treatments have been revised to use V (Velcade) for bortezomib, R (Revlimid) for lenalidomide, D (Darzalex) for daratumumab, and K (Kyprolis) for carfilzomib.

Trial Description

Primary Outcome:

• Maximal Tolerated Dose (MTD) and Recommended Phase 2 dose (RP2D) for Selinexor

Secondary Outcome:

• Number of patients with Adverse Events as a measure of safety and tolerability

Multi-centre, open-label, randomized (for dose schedule) clinical study with dose escalation (Phase 1) and expansion (Phase 2) stages to independently assess the maximum tolerated dose (MTD,) efficacy, and safety of selinexor + pomalidomide + dexamethasone (SPd), selinexor + bortezomib + dexamethasone (SVd), selinexor + lenalidomide + dexamethasone (SRd), selinexor + pomalidomide + dexamethasone + bortezomib (SPVd), selinexor + daratumumab + dexamethasone (SDd), and selinexor + carfilzomib + dexamethasone (SKd) in patients with relapsed/refractory multiple myeloma (RR MM) and newly diagnosed multiple myeloma (ND MM). SPVd arm will not open for enrollment until further notice.

View this trial on ClinicalTrials.gov