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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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2029-12-03
Completion
2029-12-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Japan
  • Poland
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714839 on ClinicalTrials.gov