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ACTIVE NOT RECRUITING Phase 1

Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma

NCT04091126 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

Conditions Studied

Interventions

  • DRUG Belantamab mafodotin
  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Bortezomib

Study Locations (20)

Other

  • GSK Investigational Site — Poitiers
  • GSK Investigational Site — Dresden
  • GSK Investigational Site — Hamburg
  • GSK Investigational Site — Schwerin
  • GSK Investigational Site — Tübingen
  • GSK Investigational Site — Bologna
  • GSK Investigational Site — Meldola FC
  • GSK Investigational Site — Lublin
  • GSK Investigational Site — Poznan
  • GSK Investigational Site — Seoul
  • GSK Investigational Site — Seoul
  • GSK Investigational Site — Seoul

Victoria

  • GSK Investigational Site — Clayton
  • GSK Investigational Site — Fitzroy

Kansas

  • GSK Investigational Site — Westwood

North Carolina

  • GSK Investigational Site — Charlotte

Wisconsin

  • GSK Investigational Site — Madison

New South Wales

  • GSK Investigational Site — Newcastle

Alberta

  • GSK Investigational Site — Edmonton

Ontario

  • GSK Investigational Site — London

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2019-12-18
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04091126

The ClinicalTrials.gov registry entry for NCT04091126 describes a study currently listed as active not 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 118 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 Belantamab mafodotin 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: NCT04091126 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Victoria, Kansas. 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 NCT04091126 about?

NCT04091126 is a clinical study titled "Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma". This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed m...

What is the current status of trial NCT04091126?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2019-12-18. Estimated completion is 2026-12-31.

What conditions does trial NCT04091126 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 NCT04091126?

The interventions under investigation include: Belantamab mafodotin (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04091126?

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 NCT04091126 being conducted?

This trial has 20 study locations across Kansas, North Carolina, Wisconsin, New South Wales, Victoria. 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