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NCT04091126 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.

Active
Registry status
Phase 1
Development phase
118
Enrollment target
20
Study locations

NCT04091126 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 118 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT04091126, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by GlaxoSmithKline.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
118 participants
Enrollment target
20
Study locations

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

Multiple Myeloma

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

1,345 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, categorized as Phase 1. The registered enrollment target is 118 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 (78% 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 Belantamab mafodotin is the first listed.

NCT04091126 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Victoria, Kansas.

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.

What interventions are being tested in trial NCT04091126?

The interventions under investigation include: Belantamab mafodotin (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT04091126?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.