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NCT04246047 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

A Phase 3 study of Multiple Myeloma, sponsored by GlaxoSmithKline.

Active
Registry status
Phase 3
Development phase
494
Enrollment target
20
Study locations

NCT04246047: Active Phase 3 study of Multiple Myeloma, sponsored by GlaxoSmithKline.

NCT04246047 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 494 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04246047, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by GlaxoSmithKline.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
494 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

Primary Outcome

PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 mill

Conditions Studied

Multiple Myeloma

Interventions

  • DRUG Belantamab mafodotin
  • DRUG Dexamethasone
  • DRUG Daratumumab
  • DRUG Bortezomib

Study Locations (20)

New South Wales

  • GSK Investigational Site - Camperdown
  • GSK Investigational Site - Liverpool
  • GSK Investigational Site - St Leonards
  • GSK Investigational Site - Waratah
  • GSK Investigational Site - Wollongong

Victoria

  • GSK Investigational Site - Box Hill
  • GSK Investigational Site - Heidelberg
  • GSK Investigational Site - Melbourne

Queensland

  • GSK Investigational Site - Benowa
  • GSK Investigational Site - Herston

Western Australia

  • GSK Investigational Site - Murdoch
  • GSK Investigational Site - Nedlands

Arizona

  • GSK Investigational Site - Yuma

Colorado

  • GSK Investigational Site - Denver

Connecticut

  • GSK Investigational Site - Fairfield

Kansas

  • GSK Investigational Site - Kansas City

Trial Details

FieldValue
Enrollment Target 494 participants
Start Date 2020-05-07
Est. Completion 2026-06-19
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the registry record for NCT04246047 still lists

NCT04246047 is an interventional study that assigns participants to a tested intervention. The registered 494 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (10% lower).

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.

NCT04246047 names 20 study sites across 12 states, led by New South Wales, Victoria, Queensland.

Frequently Asked Questions

What is clinical trial NCT04246047 about?

NCT04246047 is a clinical study titled "Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma". This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

What is the current status of trial NCT04246047?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2020-05-07. Estimated completion is 2026-06-19.

What conditions does trial NCT04246047 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT04246047?

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

Who is sponsoring clinical trial NCT04246047?

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

Where is trial NCT04246047 being conducted?

This trial has 20 study locations across Arizona, Colorado, Connecticut, Kansas, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04246047's enrollment target sits among peer trials

494 48th of 438 higher than 391 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04246047, the US trial registry maintained by the National Library of Medicine. NCT04246047 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.