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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: 123

Last updated 2026-08-19

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 belantamab 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 belantamab 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 belantamab 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.

Conditions

Interventions

DRUG

Belantamab

Belantamab will be administered.

DRUG

Belantamab mafodotin

Belantamab mafodotin will be administered.

DRUG

Pomalidomide

Pomalidomide will be administered.

DRUG

Dexamethasone

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
2028-08-03
Completion
2028-08-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • China
  • Israel
  • Japan
  • Poland
  • South Africa
  • 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