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).

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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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT02336815

Recruitment Status:

Completed

Sponsor:

Karyopharm Therapeutics Inc

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There are 51 Locations for this study

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University of Alabama
Birmingham Alabama, 35294, United States
Mayo Clinic (AZ)
Scottsdale Arizona, 85259, United States
City of Hope
Duarte California, 91010, United States
Jonnsson Comprehensive Cancer Center / University of Los Angeles
Los Angeles California, 90095, United States
Smilow Cancer Hospital
New Haven Connecticut, 06510, United States
University of Florida Health Cancer Center- Shands Cancer Center Hospital
Gainesville Florida, 32608, United States
Sylvester, University of Miami
Miami Florida, 33136, United States
H. Lee Moffitt Cancer Center Research Institute
Tampa Florida, 33612, United States
Emory University / Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Kaiser Permanente- Hawaii
Honolulu Hawaii, 96819, United States
University of Chicago Medicine
Chicago Illinois, 60637, United States
Indiana University Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Johns Hopkins Medicine
Baltimore Maryland, 21287, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48201, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Washington University St. Louis
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center / John Therurer Cancer Center
Hackensack New Jersey, 07601, United States
Valley Hospital
Paramus New Jersey, 07652, United States
Roswell Park Cancer Institute
Buffalo New York, 14203, United States
NYU Perlmutter Cancer Center
New York New York, 10016, United States
Mt Sinai NYC
New York New York, 10029, United States
Columbia University
New York New York, 10032, United States
UNC-Chapel Hill
Chapel Hill North Carolina, 27514, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
Kaiser Permanente Northwest OR
Portland Oregon, , United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Vanderbilt University Ingram Cancer Center
Nashville Tennessee, 37232, United States
Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
Swedish Cancer Institute
Seattle Washington, 98109, United States
University Hospital Krems, Department of Internal Medicine II
Krems , , Austria
Salzburg Regional Hospital Müllner
Salzburg , , Austria
Medical University Vienna, Department of Internal Medicine I
Vienna , , Austria
ZNA Stuivenberg
Antwerp , , Belgium
General Hospital Saint-Jan
Brugge , , Belgium
Jules Bordet Institute
Brussels , 1000, Belgium
UCL Saint-Luc
Brussels , B-120, Belgium
University Hospital Ghent
Ghent , , Belgium
University Hospital Leuven, Campus Gasthuisberg
Leuven , , Belgium
UCL Mont-Godinne
Yvoir , B-553, Belgium
Claude Huriez Hospital, Department of Blood Diseases
Lille , 59037, France
South Lyon Hospital Center, Department of Clinical Hematology
Lyon , 69002, France
Brabois Adults Hospital
Nancy , 54000, France
Nantes University Hospital Center
Nantes , 44093, France
Hopital Saint-Antoine, Service d´Hematologie Clinique et Therapie Cellulaire
Paris , 75012, France
La Pitie-Salpetriere University Hospital, Department of Clinical Hematology
Paris , 75013, France
Necker Children's Hospital
Paris , 75015, France
BAG Oncology Gemeinschaftspraxis
Dresden , 01307, Germany
University Hospital Freiburg, Department of Internal Medicine I
Freiburg , D-791, Germany
Universitätsklinikum Heidelberg Medizinische Klinik V
Heidelberg , 69120, Germany
Universitätsklinikum des Saarlandes Klinik für Innere Medizin I
Homburg , 66421, Germany
Universitätsmedizin Mainz
Mainz , 55122, Germany
University hospital of Tuebingen, Internal Medicine II
Tübingen , , Germany
Med. Klinik und Poliklinik II Universitätsklinikum
Würzburg , , Germany
National & Kapodistrain University of Athens School of Medicine, Alexandra Hospital
Athens , 11528, Greece

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

202

Study ID:

NCT02336815

Recruitment Status:

Completed

Sponsor:


Karyopharm Therapeutics Inc

How clear is this clinincal trial information?

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