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ACTIVE NOT RECRUITING
NCT07150091
PHASE1/PHASE2

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone 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 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

Interventions

DRUG

Belantamab mafodotin

Belantamab mafodotin will be administered.

DRUG

Nirogacestat

Nirogacestat will be administered.

DRUG

Lenalidomide

Lenalidomide will be administered.

DRUG

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