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Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM
Sponsor: GlaxoSmithKline
Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, lenalidomide, and dexamethasone, 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 6 - Belantamab Mafodotin, Nirogacestat, Lenalidomide, and Dexamethasone in Combination
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-07-19
Completion Date
2027-03-11
Last Updated
2025-09-02
Healthy Volunteers
No
Conditions
Interventions
Belantamab mafodotin
Belantamab mafodotin will be administered.
Nirogacestat
Nirogacestat will be administered.
Lenalidomide
Lenalidomide will be administered.
Dexamethasone
Dexamethasone will be administered.
Locations (12)
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Salvador, Estado de Bahia, Brazil
GSK Investigational Site
São Paulo, Brazil
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Villejuif, France
GSK Investigational Site
Hamburg, Germany
GSK Investigational Site
Athens, Greece
GSK Investigational Site
Mexico City, Mexico
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Ulsan, South Korea