drugset / Trial / 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

NCT05714839

Phase 1/2 Recruiting 123 enrolled GlaxoSmithKline
RandomizedSequentialOpen-labelTreatment

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 doses of unconjugated belantamab antibody in combination with a fixed dose of Belantamab mafodotin (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 in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.

Timeline

Start
2023-06-14
Primary completion
2028-08-03
Completion
2028-08-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Belantamab mafodotin Monoclonal antibody
Subject Unconjugated belantamab antibody Protein / enzyme biologic
Background Dexamethasone Small molecule
Background Pomalidomide Other / unclassified

Indications