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

Part of paid clinical trials in West Hollywood, California.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02628704
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    The fixed dose of selinexor is 60 mg (three 20 mg tablets)
  • Placebo (for selinexor) — DRUG
    sugar tablet manufactured to mimic selinexor tablet
  • carfilzomib — DRUG
    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 — DRUG
    Fixed oral dose of 20 mg will be given twice weekly (Days 1, 2, 8, 9, 15, 16, 22 and 23) in each cycle.

Study Details

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.

Key Dates

Start date
Dec 31, 2015
Status verified
Jan 2023
Primary completion
Jun 30, 2017
Completion
Jun 30, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
James R. Berenson MD, IncWest HollywoodCalifornia90069-
Waverly HematologyCaryNorth Carolina27518-

Find similar trials in West Hollywood, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
James R. Berenson MD, Inc· West Hollywood, CAWaverly Hematology· Cary, NC

Related Studies