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RECRUITING 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

NCT05714839 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 153 participants
Start Date 2023-06-14
Est. Completion 2029-12-03
Phase Phase 1

Sponsor

GlaxoSmithKline

558 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05714839 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Tennessee, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05714839?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial