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)
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.
Arms & interventions
- DrugBelantamab mafodotin
Belantamab mafodotin will be administered.
- DrugLenalidomide
Lenalidomide will be administered.
- DrugDexamethasone
Dexamethasone will be administered.
- DrugDaratumumab
Daratumumab will be administered.
Outcome measures
Primary
PFS
Defined as the time from the date of randomization to the date of first documented PD per International Myeloma Working Group (IMWG) criteria by Independent Review Committee (IRC) or death from any cause in the absence of progression, whichever occurs first.
Time frame: Up to approximately 7 years
Number of Participants Achieving MRD Negative Status
Defined as achieving MRD negativity at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by next-generation sequencing (NGS) at least once during the time of confirmed complete response (CR) or better response per IMWG criteria by IRC.
Time frame: Up to approximately 7 years
Secondary
Overall Survival (OS)
Time frame: Up to approximately 7 years
PFS2
Time frame: Up to approximately 7 years
Number of Participants Achieving CR or Better (CR+)
Time frame: Up to approximately 7 years
Number of Participants Achieving Very Good Partial Response (VGPR) or Better
Time frame: Up to approximately 7 years
Number of Participants Achieving Sustained MRD Negative Status
Time frame: Up to approximately 7 years
Duration of Response (DoR)
Time frame: Up to approximately 7 years
Time to Second Next Line Therapy (TTST)
Time frame: Up to approximately 7 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 7 years
Number of Participants With Ocular Findings on Ophthalmic Exam
Time frame: Up to approximately 7 years
Maximum Post-baseline Patient-Reported Outcomes Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) Score
Time frame: Up to approximately 7 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
Time frame: Up to approximately 7 years
Change From Baseline in EORTC QLQ-MY20
Time frame: Up to approximately 7 years
Plasma Concentrations of Belantamab Mafodotin
Time frame: Up to approximately 7 years
Plasma Concentrations of Cysteine Maleimidocaproyl Monomethyl Auristatin F (cys-mcMMAF)
Time frame: Up to approximately 7 years
Eligibility criteria
Study locations (30)
GSK Investigational Site
Mobile, Alabama, 36607
GSK Investigational Site
Phoenix, Arizona, 85054
GSK Investigational Site
Beverly Hills, California, 90211
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Aurora, Colorado, 80012
GSK Investigational Site
Washington D.C., District of Columbia, 20007
GSK Investigational Site
Englewood, Florida, 34223
GSK Investigational Site
Lady Lake, Florida, 32159
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Saint Augustine, Florida, 32256
GSK Investigational Site
Atlanta, Georgia, 30322
GSK Investigational Site
Portland, Maine, 04074
GSK Investigational Site
Worcester, Massachusetts, 01655
GSK Investigational Site
Ann Arbor, Michigan, 48103
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Billings, Montana, 59102
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
Stony Brook, New York, 11790
GSK Investigational Site
Charlotte, North Carolina, 28204
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Columbus, Ohio, 43214
GSK Investigational Site
Providence, Rhode Island, 02903
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Austin, Texas, 78712
GSK Investigational Site
Kingwood, Texas, 77339
GSK Investigational Site
San Antonio, Texas, 78240
GSK Investigational Site
Tyler, Texas, 75702
GSK Investigational Site
Fairfax, Virginia, 22031
GSK Investigational Site
Puyallup, Washington, 98373