Selinexor Treatment of Refractory Myeloma

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Overview

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd), both dosed twice weekly in each four-week cycle, in patients with MM previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab and refractory to prior treatment with glucocorticoids, an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and daratumumab.

SparkCures ID 739
Trial Phase Phase 2
Enrollment 210 Patients
Treatments
Trial Sponsors
  • Karyopharm Therapeutics
NCT Identifier

NCT02336815

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.

The following criteria is provided for health care professionals.

Inclusion Criteria:

Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:

  1. Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA
  2. Urinary M-protein excretion ≥ 200 mg/24 hours
  3. Free Light Chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal
  4. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative Ig levels by nephelometry or turbidimetry are acceptable
    • Must have previously received ≥ 3 anti-MM regimens including: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, either daratumumab or isatuximab, and a glucocorticoid. There is no upper limit on the number of prior therapies provided that all other inclusion/exclusion criteria are met.
    • MM refractory to previous treatment with one or more glucocorticoids, parenteral PI (i.e., bortezomib and/or carfilzomib), IMiD (i.e., lenalidomide and/or pomalidomide), and antiCD38 mAb (i.e., either daratumumab or isatuximab). Refractory is defined as ≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy.

Exclusion Criteria:

  • Active smoldering MM.
  • Active plasma cell leukemia.
  • Documented systemic amyloid light chain amyloidosis.
  • Active CNS MM.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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