Multiple Myeloma Clinical Trial
Selinexor Treatment of Refractory Myeloma
Summary
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).
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Active smoldering MM.
Active plasma cell leukemia.
Documented systemic amyloid light chain amyloidosis.
Active CNS MM.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 51 Locations for this study
Birmingham Alabama, 35294, United States
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
Los Angeles California, 90095, United States
New Haven Connecticut, 06510, United States
Gainesville Florida, 32608, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Honolulu Hawaii, 96819, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Paramus New Jersey, 07652, United States
Buffalo New York, 14203, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
Chapel Hill North Carolina, 27514, United States
Canton Ohio, 44718, United States
Portland Oregon, , United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Seattle Washington, 98109, United States
Krems , , Austria
Salzburg , , Austria
Vienna , , Austria
Antwerp , , Belgium
Brugge , , Belgium
Brussels , 1000, Belgium
Brussels , B-120, Belgium
Ghent , , Belgium
Leuven , , Belgium
Yvoir , B-553, Belgium
Lille , 59037, France
Lyon , 69002, France
Nancy , 54000, France
Nantes , 44093, France
Paris , 75012, France
Paris , 75013, France
Paris , 75015, France
Dresden , 01307, Germany
Freiburg , D-791, Germany
Heidelberg , 69120, Germany
Homburg , 66421, Germany
Mainz , 55122, Germany
Tübingen , , Germany
Würzburg , , Germany
Athens , 11528, Greece
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.