A Phase 3, Randomized, Open-label 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 Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
GlaxoSmithKline
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 informed consent form and in the protocol. 3. NDMM with a requirement for treatment as documented per IMWG criteria. 4. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following: 1. Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours…
Interventions
- DrugBelantamab mafodotin
Belantamab mafodotin will be administered.
- DrugLenalidomide
Lenalidomide will be administered.
- DrugDexamethasone
Dexamethasone will be administered.
- DrugDaratumumab
Daratumumab will be administered.
Locations (181)
- GSK Investigational SiteMobile, Alabama
- GSK Investigational SitePhoenix, Arizona
- GSK Investigational SiteBeverly Hills, California
- GSK Investigational SitePasadena, California
- GSK Investigational SiteAurora, Colorado
- GSK Investigational SiteWashington D.C., District of Columbia