NCT06956170

All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Belantamab mafodotin	Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
DRUG	Pomalidomide	Immunomodulatory drug (IMiD) will be administered.
DRUG	Dexamethasone	Synthetic glucocorticoid with anti-tumor activity will be administered.
DRUG	Bortezomib	Proteasome Inhibitor will be administered.

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-05-27
• Completion: 2029-11-30
• First posted: 2025-05-04
• Last updated: 2025-06-11
• Results posted: 2025-06-11

Locations

13 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study