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NCT05714839 · ClinicalTrials.gov registry record · Phase 1
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 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT05714839 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 153 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT05714839, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG 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
Study Locations (20)
Other
- GSK Investigational Site - Ciudadela
- GSK Investigational Site - San Juan Bautista
- GSK Investigational Site - Viedma
- GSK Investigational Site - Joinville
- GSK Investigational Site - Salvador
- GSK Investigational Site - São Paulo
- GSK Investigational Site - Aomori
- GSK Investigational Site - Chiba
- GSK Investigational Site - Osaka
- GSK Investigational Site - Tokyo
- GSK Investigational Site - Gdansk
- GSK Investigational Site - Lublin
- GSK Investigational Site - Seoul
- GSK Investigational Site - Seoul
Tennessee
- GSK Investigational Site - Chattanooga
- GSK Investigational Site - Nashville
Michigan
- GSK Investigational Site - Grand Rapids
North Carolina
- GSK Investigational Site - Chapel Hill
Victoria
- GSK Investigational Site - Fitzroy
Western Australia
- GSK Investigational Site - Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2023-06-14 |
| Est. Completion | 2029-12-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05714839
The ClinicalTrials.gov registry entry for NCT05714839 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (72% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Unconjugated belantamab antibody is the first listed.
NCT05714839 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, Tennessee, Michigan.
Frequently Asked Questions
What is clinical trial NCT05714839 about?
NCT05714839 is a clinical study titled "A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments". 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 pri...
What is the current status of trial NCT05714839?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2023-06-14. Estimated completion is 2029-12-03.
What conditions does trial NCT05714839 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT05714839?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT05714839?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05714839 being conducted?
This trial has 20 study locations across Michigan, North Carolina, Tennessee, Victoria, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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