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

Sponsor
Karyopharm Therapeutics Inc (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02628704
Collaborator
(none)
0
2
2
30
0
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Selinexor, carfilzomib and dexamethasone

60 mg of selinexor and and 20 mg of dexamethasone will be taken twice weekly. On days coinciding with carfilzomib administration, selinexor will be given between 30 minutes and 4 hours after the end of the carfilzomib infusion.

Drug: Selinexor
The fixed dose of selinexor is 60 mg (three 20 mg tablets)
Other Names:
  • KCP-330
  • 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.
    Other Names:
  • Kyprolis
  • 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.

    Placebo Comparator: Placebo, carfilzomib and dexamethasone

    Placebo (for 60 mg of selinexor) and and 20 mg of dexamethasone will be taken twice weekly. On days coinciding with carfilzomib administration, Placebo (for 60 mg of selinexor) will be given between 30 minutes and 4 hours after the end of the carfilzomib infusion.

    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.
    Other Names:
  • Kyprolis
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 James R. Berenson MD, Inc West Hollywood California United States 90069
    2 Waverly Hematology Cary North Carolina United States 27518

    Sponsors and Collaborators

    • Karyopharm Therapeutics Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karyopharm Therapeutics Inc
    ClinicalTrials.gov Identifier:
    NCT02628704
    Other Study ID Numbers:
    • KCP-330-015
    First Posted:
    Dec 11, 2015
    Last Update Posted:
    Mar 30, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Karyopharm Therapeutics Inc
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 30, 2017