Spots Global Cancer Trial Database for A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
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Trial Identification
Brief Title: A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Official Title: A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)
Study ID: NCT03525678
Conditions
Study Description
Brief Summary: Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, New Haven, Connecticut, United States
GSK Investigational Site, Atlanta, Georgia, United States
GSK Investigational Site, Atlanta, Georgia, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Indianapolis, Indiana, United States
GSK Investigational Site, Fairway, Kansas, United States
GSK Investigational Site, New Orleans, Louisiana, United States
GSK Investigational Site, Baltimore, Maryland, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Rochester, Minnesota, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Charlotte, North Carolina, United States
GSK Investigational Site, Columbus, Ohio, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Nashville, Tennessee, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Salt Lake City, Utah, United States
GSK Investigational Site, Seattle, Washington, United States
GSK Investigational Site, Madison, Wisconsin, United States
GSK Investigational Site, Woodville, South Australia, Australia
GSK Investigational Site, Fitzroy, Victoria, Australia
GSK Investigational Site, Melbourne, Victoria, Australia
GSK Investigational Site, Calgary, Alberta, Canada
GSK Investigational Site, Winnipeg, Manitoba, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Lille Cedex, , France
GSK Investigational Site, Nantes cedex 1, , France
GSK Investigational Site, Paris, , France
GSK Investigational Site, Pessac, , France
GSK Investigational Site, Pierre-Bénite cedex, , France
GSK Investigational Site, Toulouse cedex 9, , France
GSK Investigational Site, Tuebingen, Baden-Wuerttemberg, Germany
GSK Investigational Site, Wuerzburg, Bayern, Germany
GSK Investigational Site, Schwerin, Mecklenburg-Vorpommern, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Koblenz, Rheinland-Pfalz, Germany
GSK Investigational Site, Dresden, Sachsen, Germany
GSK Investigational Site, Rionero In Vulture (Pz), Basilicata, Italy
GSK Investigational Site, Parma, Emilia-Romagna, Italy
GSK Investigational Site, Aviano (PN), Friuli-Venezia-Giulia, Italy
GSK Investigational Site, Torino, Piemonte, Italy
GSK Investigational Site, Badalona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Granada, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Murcia, , Spain
GSK Investigational Site, Pamplona, , Spain
GSK Investigational Site, Pozuelo De Alarcón/Madrid, , Spain
GSK Investigational Site, Salamanca, , Spain
GSK Investigational Site, Valencia, , Spain
GSK Investigational Site, Stoke-on-Trent, Staffordshire, United Kingdom
GSK Investigational Site, Sutton, Surrey, United Kingdom
GSK Investigational Site, Birmingham, , United Kingdom
GSK Investigational Site, Bournemouth, , United Kingdom
GSK Investigational Site, Headington, Oxford, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Nottingham, , United Kingdom
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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