Joint Clinical Trials Office

A Phase 3 randomized open-label study of belantamab mafodotin in combination with lenalidomide and dexamethasone versus daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma who are ineligible for auto-SCT

Clinical Trial Details

The goal of this clinical trial is to compare the safety and efficacy of belantamab mafodotin combinated with lenalidomide and dexamethasone to the combination of daratumumab, lenalidomide and dexamethasone in participants who have newly diagnosed multiple myeloma and are not eligible for autologous stem cell transplantation. The study also wants to determihne if the study drug is safer and works better than the current standard of care treatment.

Belantamab mafodotin is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA).

Belantamab mafodotin will be combined with 2 drugs already approved by the FDA to treat multiple myeloma: lenalidomide and dexamethasone. Everyone in the study will take these 2 standard drugs, but some will also take, daratumumab, instead of belantamab mafodotin. Daratumumab is also FDA-approved for multiple myeloma.

Participants will be randomized to one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Depending on the treatment group, participants will either get intravenous (IV through a vein in the arm) treatment or subcutaneous injection (needle beneath the skin). Both groups will also take capsules and tablets by mouth.

There is no defined length of time for this study, and the duration of the study will be different for every participant depending on their health. 

Key Eligibility: 

Inclusion Criteria:

  1. At least 18 years of age or older
  2. Newly diagnosed multiple myeloma 
  3. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory
  4. Male participants must refrain from donating fresh, unwashed semen PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR must agree to use contraception/barrier
  5. Female participants must not be pregnant or breastfeeding, and is either not a woman of childbearing potential or if they are a woman of childbearing potential, yse a contraceptive method that is highly effective and agree to not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. 

Exclusion Criteria:

  1.  Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or Primary Plasma Cell Leukemia 
  2. Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma.
  3. Signs of meningeal or central nervous system involvement with multiple myeloma.
  4. Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. 
  5. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with the participant's safety, obtaining informed consent, or compliance with study procedures.

  Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Mateo Mejia Saldarriaga, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2508029229

ClinicalTrials.gov:

NCT06679101

Sponsor:

214828

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • GlaxoSmithKline

Disease

Multiple Myeloma