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

NCT04246047 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2026-04-23

Study results available
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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.

Conditions

Interventions

DRUG

Belantamab mafodotin

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate

DRUG

Daratumumab

Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody

DRUG

Bortezomib

Proteasome Inhibitor

DRUG

Dexamethasone

Synthetic glucocorticoid with anti-tumor activity

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2023-10-02
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • Greece
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246047 on ClinicalTrials.gov