Belantamab Mafodotin for Newly Diagnosed Multiple Myeloma

A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

Recruiting Phase 3 Interventional Study
Multiple Myeloma Newly Diagnosed Multiple Myeloma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
520 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for

This trial is looking for adults who have recently been diagnosed with multiple myeloma and cannot receive high-dose chemotherapy with stem cell transplantation. Participants will receive one of two treatment combinations and be monitored for their response to the treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I can provide consent to participate in the trial.
  • I have newly diagnosed multiple myeloma that requires treatment.
  • I have measurable disease based on specific lab tests.
  • I am not a candidate for high-dose chemotherapy with stem cell transplant.
  • I have an ECOG performance status of 0 to 2.
  • I have adequate organ function.

You may not be able to join if

  • I have a diagnosis of systemic amyloid light chain amyloidosis.
  • I have received prior treatment for multiple myeloma.
  • I have signs of central nervous system involvement with multiple myeloma.
  • I had major surgery within the last 2 weeks.
  • I have serious medical or psychiatric conditions that might affect my safety.
  • I have current liver disease other than stable conditions.
  • I have had a recent heart attack or other serious heart conditions.
  • I am known to be HIV positive without manageable viral load.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. 2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informe…
Contacts

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

CONTACT

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

CONTACT