Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following:
Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate organ system function as defined by the laboratory assessments.
Male participants:
PLUS either:
OR
Female participants
Exclusion criteria
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.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the investigator's assessment).
Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are any other malignancy that has been considered medically stable for at least 2 years, after discussion with the GSK Medical Monitor. The participant must not be receiving active therapy, other than hormonal therapy for this disease.
Evidence of cardiovascular risk including any of the following:
Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention unless the participant can meet the following criteria:
Participants with hepatitis B will be excluded unless the defined criteria can be met.
Current corneal epithelial disease except for mild punctate keratopathy.
Intolerance or contraindications to antiviral prophylaxis.
Unable to tolerate antithrombotic prophylaxis.
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study intervention.
Plasmapheresis within 7 days prior to the first dose of study intervention.
Participants must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.
Primary purpose
Allocation
Interventional model
Masking
520 participants in 2 patient groups
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Central trial contact
US GSK Clinical Trials Call Center; EU GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
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