NCT04126200

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (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) - DREAMM 5

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Belantamab mafodotin	Belantamab mafodotin will be administered.
DRUG	GSK3174998	GSK3174998 will be administered.
DRUG	Feladilimab	feladilimab will be administered.
DRUG	Nirogacestat	Nirogacestat will be administered.
DRUG	Dostarlimab	Dostarlimab will be administered.
DRUG	Isatuximab	Isatuximab will be administered.
DRUG	Lenalidomide	Lenalidomide will be administered.
DRUG	Dexamethasone	Dexamethasone will be administered.
DRUG	Pomalidomide	Pomalidomide will be administered.

Timeline

• Start date: 2019-10-07
• Primary completion: 2025-04-17
• Completion: 2027-03-11
• First posted: 2019-10-15
• Last updated: 2025-11-06

Locations

42 sites across 15 countries: United States, Australia, Brazil, Canada, France, Germany, Greece, Mexico, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden

Regulatory

• FDA-regulated drug study