Spots Global Cancer Trial Database for Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma

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Trial Identification

Brief Title: Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma

Official Title: 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

Study ID: NCT02628704

Conditions

Multiple Myeloma

Interventions

Selinexor

Placebo (for selinexor)

carfilzomib

Dexamethasone

Study Description

Brief 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