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
Conditions
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 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, , 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 für Innere Medizin I, Homburg, , Germany
Universitätsmedizin Mainz, Mainz, , 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, , Greece
Contact Details
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