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Selinexor Treatment of Refractory Myeloma
Trial Status: complete
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).
Inclusion Criteria
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, 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.
Exclusion Criteria:
- Active smoldering MM.
- Active plasma cell leukemia.
- Documented systemic amyloid light chain amyloidosis.
- Active CNS MM.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02336815.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Gary John Schiller
Phone: 888-798-0719
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Andrzej J. Jakubowiak
Phone: 888-824-0200
Michigan
Ann Arbor
University of Michigan Rogel Cancer Center
Status: Active
Name Not Available
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.
This study consists of two parts:
- Part 1 enrolled patients with both quad-refractory MM and penta-refractory MM.
- Part 2 will enroll patients with penta-refractory MM only.
