RecruitingPhase 1Phase 2NCT05714839

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


Sponsor

GlaxoSmithKline

Enrollment

153 participants

Start Date

Jun 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing belantamab mafodotin — an antibody-drug that targets a protein on multiple myeloma cells — both alone and in combination with other treatments, for patients whose multiple myeloma has returned or stopped responding to previous therapies. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of multiple myeloma - Your cancer has relapsed or progressed after previous treatment - You have received at least 3 prior lines of treatment (including lenalidomide, a proteasome inhibitor, and an anti-CD38 antibody) for most study parts; or at least 1 prior treatment for part 3 - Your disease is measurable by blood or urine tests - You are in generally good health (ECOG performance status 0–2) - If you previously had a stem cell transplant, it was at least 100 days ago with no active infection **You may NOT be eligible if...** - Your myeloma is clinically unstable or progressing very rapidly - You have significant organ damage (heart, kidney, liver) beyond the study's acceptable limits - You have an active serious infection - You are pregnant or breastfeeding - You have previously had a severe reaction to belantamab or similar drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGUnconjugated belantamab antibody

Unconjugated belantamab antibody will be administered.

DRUGBelantamab mafodotin

Belantamab mafodotin will be administered.

DRUGUnconjugated belantamab antibody and belantamab mafodotin

Unconjugated belantamab antibody and belantamab mafodotin used in combination (delivered as separate drugs) will be administered.

DRUGUnconjugated 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05714839


Related Trials