NCT06655818

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) 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 4 - Belantamab Mafodotin and Dostarlimab (GSK4057190) in Combination

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (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 other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the cohort expansion phase. This study is a sub study of the Master protocol (NCT04126200).

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Belantamab Mafodotin	Belantamab Mafodotin will be administered.
DRUG	Dostarlimab	Dostarlimab will be administered.

Timeline

• Start date: 2021-03-09
• Primary completion: 2024-02-14
• Completion: 2024-02-14
• First posted: 2024-10-23
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

3 sites across 2 countries: France, South Korea

Regulatory

• FDA-regulated drug study