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Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM
Sponsor: GlaxoSmithKline
Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat and to establish the recommended Phase 2 dose for combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Official title: A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 3 - Belantamab Mafodotin and Nirogacestat in Combination
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2020-06-08
Completion Date
2027-03-11
Last Updated
2025-07-25
Healthy Volunteers
No
Conditions
Interventions
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Locations (29)
238995
Atlanta, Georgia, United States
240593
Boston, Massachusetts, United States
251164
Grand Rapids, Michigan, United States
239015
Madison, Wisconsin, United States
GSK Investigational Site
Fitzroy, Victoria, Australia
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Lille, France
GSK Investigational Site
Villejuif, France
GSK Investigational Site
Frankfurt, Germany
GSK Investigational Site
Kiel, Germany
GSK Investigational Site
Leipzig, Germany
GSK Investigational Site
Athens, Greece
GSK Investigational Site
Utrecht, Netherlands
GSK Investigational Site
Oslo, Norway
GSK Investigational Site
Katowice, Poland
GSK Investigational Site
Lodz, Poland
GSK Investigational Site
Lublin, Poland
GSK Investigational Site
Moscow, Russia
GSK Investigational Site
Incheon, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Ulsan, South Korea
GSK Investigational Site
Badalona, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain
GSK Investigational Site
Falun, Sweden
GSK Investigational Site
Stockholm, Sweden