Last updated on November 2018

Bortezomib Selinexor and Dexamethasone in Patients With Multiple Myeloma

Brief description of study

This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.

Clinical Study Identifier: NCT03110562

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The Alfred Hospital

Melbourne, Australia
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UCL Saint-Luc

Brussels, Belgium
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University of Cincinnati Health

Cincinnati, OH United States
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McFarland Clinic

Ames, IA United States
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L'H tel-Dieu de Qu bec

Quebec City, QC Canada
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University of Maryland

Baltimore, MD United States
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Prairie Lakes Healthcare

Watertown, SD United States
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Flinders Medical Centre

Bedford Park, Australia
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Novant-Forsyth Memorial Hospital

Winston-Salem, NC United States
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Mount Sinai

New York, NY United States
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Central Care Cancer Center

Bolivar, MO United States
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Commonwealth Hematology

Danville, KY United States
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Regional Cancer Centre

Thiruvananthapuram, India
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Emory University

Atlanta, GA United States
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Norton Cancer Institute

Louisville, KY United States
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Kaiser Permanente Hawaii

Honolulu, HI United States
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Recruitment Status: Open

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