NCT05714839

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study consists of three parts: * Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). * Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with Unconjugated belantamab antibody (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the unconjugated belantamab antibody, either alone or in combination with belantamab mafodotin alongside the standard of care (SoC) pomalidomide-dexamethasone backbone. The study will focus on patients with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Unconjugated belantamab antibody	Unconjugated belantamab antibody will be administered.
DRUG	Belantamab mafodotin	Belantamab mafodotin will be administered.
DRUG	Unconjugated belantamab antibody and belantamab mafodotin	Unconjugated belantamab antibody and belantamab mafodotin used in combination (delivered as separate drugs) will be administered.
DRUG	Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin	Unconjugated belantamab antibody and belantamab mafodotin in combination with pomalidomide-dexamethasone and Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone will be administered.

Timeline

• Start date: 2023-06-14
• Primary completion: 2029-12-03
• Completion: 2029-12-03
• First posted: 2023-02-06
• Last updated: 2026-01-23

Locations

27 sites across 10 countries: United States, Argentina, Australia, Brazil, Japan, Poland, South Korea, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study