NCT07150091

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-19
• Primary completion: 2025-04-17
• Completion: 2027-03-11
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

12 sites across 8 countries: United States, Brazil, Canada, France, Germany, Greece, Mexico, South Korea

Regulatory

• FDA-regulated drug study