NCT02628704

Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma

Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Selinexor (KPT-330), Carfilzomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma Previously Treated With a Proteasome Inhibitor and an Immunomodulatory Drug

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.

Detailed description

This is a Phase 2, two-arm, randomized, placebo-controlled, double-blind, multicenter study of relapsed/refractory multiple myeloma patients who have received at least two prior therapies, including a proteasome inhibitor and an IMiD. Patients who meet all the eligibility criteria will be randomized to one of two blinded treatment arms: * selinexor + carfilzomib + dexamethasone * placebo + carfilzomib + dexamethasone

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Selinexor	The fixed dose of selinexor is 60 mg (three 20 mg tablets)
DRUG	Placebo (for selinexor)	sugar tablet manufactured to mimic selinexor tablet
DRUG	carfilzomib	Administered as an IV infusion on Days 1, 2, 8, 9, 15 and 16 of each 4-week cycle for Cycles 1-13 and then on Days 1, 2, 15, and 16 for Cycles ≥ 14.
DRUG	Dexamethasone	Fixed oral dose of 20 mg will be given twice weekly (Days 1, 2, 8, 9, 15, 16, 22 and 23) in each cycle.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2015-12-11
• Last updated: 2023-01-26

Locations

2 sites across 1 country: United States