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

Karyopharm Therapeutics Inc

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Multiple Myeloma

Interventions

SelinexorDRUG

The fixed dose of selinexor is 60 mg (three 20 mg tablets)

Placebo (for selinexor)DRUG

sugar tablet manufactured to mimic selinexor tablet

carfilzomibDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic, histologically confirmed MM, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following: * Serum M-protein ≥ 1.0 g/dL by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative IgA; or * Urinary M-protein excretion at least 200 mg/24 hours; or * Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal. * If serum protein electrophoresis is felt to be unreliable for routine M- protein measurement, then quantitative Ig levels by nephelometry or turbidometry are acceptable. * Must have received ≥ 2 prior anti-MM therapies including a proteasome inhibitor and an IMiD. The most recent proteasome inhibitor must not have been carfilzomib. * Patients previously treated with carfilzomib are eligible as long as they meet the following criteria: * Not received carfilzomib within 6 months (183 days) of Cycle 1 Day 1 (C1D1), and * Carfilzomib was not part of their most recent therapy for the treatment of MM, and * Did not discontinue carfilzomib treatment because of adverse effects. * MM that is refractory to the most recent treatment regimen. Refractory is defined as ≤ 25% response to therapy, or progression during therapy, or progression on or within 60 days after completion of therapy. Exclusion Criteria: * Smoldering MM. * Active plasma cell leukemia. * MM that does not express M-protein or serum FLC (i.e., non-secretory MM is excluded; plasmacytomas without M-protein or serum FLC are excluded). * Documented active systemic amyloid light chain amyloidosis. * Active MM involving the central nervous system. * Active polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. * Prior autologous stem cell transplantation \< 1 month or allogenic stem cell transplantation \< 3 months prior to C1D1. * Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.

Locations (2)

James R. Berenson MD, Inc

West Hollywood, California, United States

Waverly Hematology

Cary, North Carolina, United States

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes

Overall Response Rate (ORR)

Time frame: Assessed from the date of first dose of blinded study treatment until the date that PD assessed up to 24 months

Data from ClinicalTrials.gov

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