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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
520
Belantamab mafodotin will be administered.
Lenalidomide will be administered.
Dexamethasone will be administered.
Daratumumab will be administered.
GSK Investigational Site
Mobile, Alabama, United States
RECRUITINGGSK Investigational Site
Phoenix, Arizona, United States
RECRUITINGGSK Investigational Site
Beverly Hills, California, United States
RECRUITINGGSK Investigational Site
Pasadena, California, United States
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
PFS2
Defined as the time from the date of randomization to the date of documented PD following the first subsequent anti-myeloma therapy or death from any cause, whichever is earlier.
Time frame: Up to approximately 7 years
Overall Survival (OS)
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
Defined as achieving MRD negative status at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR+ response per IMWG criteria by IRC.
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
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Time frame: Up to approximately 7 years
Titers of ADAs Against Belantamab Mafodotin
Time frame: Up to approximately 7 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Aurora, Colorado, United States
RECRUITINGGSK Investigational Site
Englewood, Florida, United States
RECRUITINGGSK Investigational Site
Lady Lake, Florida, United States
RECRUITINGGSK Investigational Site
Pembroke Pines, Florida, United States
RECRUITINGGSK Investigational Site
Saint Augustine, Florida, United States
RECRUITINGGSK Investigational Site
Atlanta, Georgia, United States
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