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

Multiple Myeloma Clinical Trial

— SCORE  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02628704
• Other study ID #: KCP-330-015
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: June 2018

Study information

• Verified date: January 2023
• Source: Karyopharm Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Selinexor
The fixed dose of selinexor is 60 mg (three 20 mg tablets)
• Placebo (for selinexor)
sugar tablet manufactured to mimic selinexor tablet
• 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.
• 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.

Locations

Country	Name	City	State
United States	Waverly Hematology	Cary	North Carolina
United States	James R. Berenson MD, Inc	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Karyopharm Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		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	Overall Response Rate (ORR)		Assessed from the date of first dose of blinded study treatment until the date that PD assessed up to 24 months