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RECRUITING
NCT05714839
PHASE1/PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2023-06-14

Completion Date

2029-12-03

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

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.

Locations (27)

GSK Investigational Site

Grand Rapids, Michigan, United States

GSK Investigational Site

Chapel Hill, North Carolina, United States

GSK Investigational Site

Chattanooga, Tennessee, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Ciudadela, Argentina

GSK Investigational Site

San Juan Bautista, Argentina

GSK Investigational Site

Viedma, Argentina

GSK Investigational Site

Fitzroy, Victoria, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Joinville, Brazil

GSK Investigational Site

Salvador, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Aomori, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Gdansk, Poland

GSK Investigational Site

Lublin, Poland

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Changhua, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Kayseri, Turkey (Türkiye)

GSK Investigational Site

Leicester, United Kingdom

GSK Investigational Site

Oxford, United Kingdom

GSK Investigational Site

Plymouth, United Kingdom