Selinexor Treatment of Refractory Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

Key facts

Study ID

NCT02336815

Run by

Karyopharm Therapeutics Inc

People needed

202

Starts

2015-05-26

Expected to finish

2019-07-26

Last updated by the study team

2023-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:
• Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA
• Urinary M-protein excretion ≥ 200 mg/24 hours
• Free Light Chain (FLC) ≥ 100 mg/L, provided that the 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 turbidimetry are acceptable
• Must have previously received ≥ 3 anti-MM regimens including: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, 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 the anti-CD38 mAb, daratumumab. Refractory is defined as ≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy.

You may not qualify if…

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

Where it is running

• Mayo Clinic (AZ) — Scottsdale, Arizona, United States
• City of Hope — Duarte, California, United States
• Jonnsson Comprehensive Cancer Center / University of Los Angeles — Los Angeles, California, United States
• Smilow Cancer Hospital — New Haven, Connecticut, United States
• University of Florida Health Cancer Center- Shands Cancer Center Hospital — Gainesville, Florida, United States
• Sylvester, University of Miami — Miami, Florida, United States
• H. Lee Moffitt Cancer Center Research Institute — Tampa, Florida, United States
• Emory University / Winship Cancer Institute — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Kaiser Permanente- Hawaii — Honolulu, Hawaii, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Johns Hopkins Medicine — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University St. Louis — St Louis, Missouri, United States
• Hackensack University Medical Center / John Therurer Cancer Center — Hackensack, New Jersey, United States
• Valley Hospital — Paramus, New Jersey, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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