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Spots Global Cancer Trial Database for Selinexor Treatment of Refractory Myeloma

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Trial Identification

Brief Title: Selinexor Treatment of Refractory Myeloma

Official Title: A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab

Study ID: NCT02336815

Study Description

Brief 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).

Detailed 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama, Birmingham, Alabama, United States

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, Saint Louis, Missouri, United States

Hackensack University Medical Center / John Therurer Cancer Center, Hackensack, New Jersey, United States

Valley Hospital, Paramus, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

NYU Perlmutter Cancer Center, New York, New York, United States

Mt Sinai NYC, New York, New York, United States

Columbia University, New York, New York, United States

UNC-Chapel Hill, Chapel Hill, North Carolina, United States

Gabrail Cancer Center, Canton, Ohio, United States

Kaiser Permanente Northwest OR, Portland, Oregon, United States

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Vanderbilt University Ingram Cancer Center, Nashville, Tennessee, United States

Baylor Sammons Cancer Center, Dallas, Texas, United States

Swedish Cancer Institute, Seattle, Washington, United States

University Hospital Krems, Department of Internal Medicine II, Krems, , Austria

Salzburg Regional Hospital MĂźllner, 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, , Belgium

UCL Saint-Luc, Brussels, , Belgium

University Hospital Ghent, Ghent, , Belgium

University Hospital Leuven, Campus Gasthuisberg, Leuven, , Belgium

UCL Mont-Godinne, Yvoir, , Belgium

Claude Huriez Hospital, Department of Blood Diseases, Lille, , France

South Lyon Hospital Center, Department of Clinical Hematology, Lyon, , France

Brabois Adults Hospital, Nancy, , France

Nantes University Hospital Center, Nantes, , France

Hopital Saint-Antoine, Service d´Hematologie Clinique et Therapie Cellulaire, Paris, , France

La Pitie-Salpetriere University Hospital, Department of Clinical Hematology, Paris, , France

Necker Children's Hospital, Paris, , France

BAG Oncology Gemeinschaftspraxis, Dresden, , Germany

University Hospital Freiburg, Department of Internal Medicine I, Freiburg, , Germany

Universitätsklinikum Heidelberg Medizinische Klinik V, Heidelberg, , Germany

Universitätsklinikum des Saarlandes Klinik fßr Innere Medizin I, Homburg, , Germany

Universitätsmedizin Mainz, Mainz, , Germany

University hospital of Tuebingen, Internal Medicine II, TĂźbingen, , Germany

Med. Klinik und Poliklinik II Universitätsklinikum, Wßrzburg, , Germany

National & Kapodistrain University of Athens School of Medicine, Alexandra Hospital, Athens, , Greece

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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