Phase 1b/2 Study of Selinexor (KPT-330) in Combination w/ Backbone Treatments for Relapsed/Refractory Multiple Myeloma (STOMP)

Overview

This study will independently assess the efficacy and safety of three combination therapies for the treatment of patients with relapsed/refractory multiple myeloma (RR MM): selinexor + dexamethasone + pomalidomide (SdP) and selinexor + dexamethasone + bortezomib (SdB), selinexor + dexamtheasone + lenalidomide.

  • Patients are consented and then assigned to a treatment arm based on their previous treatment regimen.  
  • Once eligibility is confirmed, the patient is randomized to receive selinexor either once or twice weekly. 
  • Three visits to site for first monthly cycle, two visits during the 2nd cycle and one monthly visit thereafter while on therapy. 
  • End of treatment visit required 14 days after last dose, and safety follow up or call 30 days after last dose. 
  • Telephone or in person visits  every 3 months thereafter.
SparkCures ID 738
Trial Phase Phase 1/2
Enrollment 140 Patients
Treatments
Trial Sponsors
  • Karyopharm Therapeutics
NCT Identifier

NCT02343042

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

  • Symptomatic multiple myeloma.
  • Documented progression following prior proteasome inhibitor or IMiD based therapy.
  • Adequate performance status, hematopoietic, liver and kidney function.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Histologically confirmed diagnosis, measurable disease and evidence of disease progression of multiple myeloma, as described below.
  • Symptomatic multiple myeloma, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following:
    • Serum M-protein ≥ 5 g/L by serum electrophoresis (SPEP) or for immunoglobulin A (IgA) myeloma, by quantitative IgA; or
    • Urinary M-protein excretion at least 200 mg/24 hours; or
    • Involved serum free light chains ≥ 100 mg/L, provided that free light chain ratio is abnormal
    • If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels by nephelometry or turbidometry are acceptable.
  • Resolution of prior drug-related toxicities to ≤ Grade 2.
  • Relapsed and/or refractory multiple myeloma.

Exclusion Criteria:

  • Smoldering MM.
  • Multiple myeloma that does not express M-protein or Free Light Chain(FLC) (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead.
  • Documented systemic amyloid light chain amyloidosis.
  • Active MM involving the central nervous system (CNS).
  • Plasma cell leukemia.
  • On the selinexor + dexamethasone + bortezomib (SdB) arm only: prior history of neuropathy Grade > 2, or Grade 2 neuropathy with pain at baseline (within 14 days prior to Cycle 1 Day 1).

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

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University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

California
New York
University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

North Carolina
Verified UNC Lineberger Comprehensive Cancer Center<br />University of North Carolina

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Texas
Washington
Wisconsin

Resources

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