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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 14, 2023
Primary Completion Date
December 3, 2029
Completion Date
December 3, 2029
Last Updated
January 23, 2026
153
ESTIMATED participants
Unconjugated belantamab antibody
DRUG
Belantamab mafodotin
DRUG
Unconjugated belantamab antibody and belantamab mafodotin
DRUG
Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin
DRUG
Lead Sponsor
GlaxoSmithKline
NCT06152575
NCT06179888
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04973605