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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

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.

Eligibility criteria

Qualifiers

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.

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.

NDMM with a requirement for treatment as documented per IMWG criteria.

Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or

Disqualifiers

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 (defined as circulating plasma cells >5%).

Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma.

Signs of meningeal or central nervous system involvement with multiple myeloma.

Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. Kyphoplasty is not considered major surgery.

Trial design

Treatments tested in this trial

  • Belantamab mafodotin
  • Lenalidomide
  • Dexamethasone
  • Daratumumab

Treatment groups

520 Participants
are divided into 2 treatment groups

Sponsors and collaborators