This study aims to compare how belantamab behaves in the body when given as an injection under the skin (SC) versus into a vein (IV) in participants with multiple myeloma who are receiving standard of care treatment, to enable eventual development of SC formulation. It will assess how much belantamab is absorbed and how long it stays in the blood as well as assess whether it is safe and tolerated well by participants.
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, and skin changes (POEMS) syndrome, primary plasma cell leukemia, or non-secretory myeloma.
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.
Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab, or hyaluronidase, or any of the components of the study treatment. History of severe hypersensitivity to other monoclonal antibodies (mAbs).
Active infection requiring antibiotic, antiviral, or antifungal treatment.
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety).
Prior B cell maturation antigen (BCMA) directed therapy.
Plasmapheresis within 7 days prior to the first dose of study drug.
Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first dose or has not recovered fully from surgery.
Participants must not receive live/live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab for at least 70 days following last study treatment.
Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type within 60 days of an investigational medicinal product before randomization.
Known human immunodeficiency virus (HIV) infection, unless the participant can meet all the following criteria:
Participants with hepatitis B virus (HBV) infection will be excluded
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 treatment unless the participant can meet the following criteria:
Is pregnant or breastfeeding.
Evidence of cardiovascular risk including any of the following:
GSKClinicalSupportHD@gsk.com
Participants will receive Belantamab subcutaneous (SC) dose level 1 (DL1) +Recombinant Human Hyaluronidase PH20 (rHuPH20) in Period 1; followed by Belantamab intravenous (IV) DL1 in Period 2; followed by Belantamab SC DL2 + rHuPH20 in Period 3; further followed by Belantamab SC DL1 + rHuPH20 in Period 4. Dose level 1 is the lowest dose level.
Participants will receive Belantamab IV DL1 in Period 1; followed by Belantamab SC DL1 + rHuPH20 in Period 2; followed by Belantamab SC DL2 + rHuPH20 in Period 3; further followed by Belantamab SC DL1 + rHuPH20 in Period 4 of the study. Dose level 1 is the lowest dose level.
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