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ACTIVE NOT RECRUITING
NCT07217184
PHASE1/PHASE2

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the 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 5 - Belantamab Mafodotin and Isatuximab in Combination

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-07-29

Completion Date

2027-03-11

Last Updated

2025-10-15

Healthy Volunteers

No

Interventions

DRUG

Belantamab mafodotin

Belantamab mafodotin will be administered.

DRUG

Isatuximab

Isatuximab will be administered.

Locations (19)

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Grand Rapids, Michigan, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Fitzroy, Victoria, Australia

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Villejuif, France

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Ulsan, South Korea

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Pozuelo de AlarcOn Madr, Spain

GSK Investigational Site

Falun, Sweden