study to investigate alternative dosing regimens of belantamab mafodotin in participants with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (rrmm) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.


Eligibility criteria:
inclusion criteria: * participant must be 18 years of age inclusive at the time of signing the informed consent form (icf). * eastern cooperative oncology group (ecog) performance status of 0 to 2. * histologically or cytologically confirmed diagnosis of mm and a. has undergone stem cell transplant or is considered transplant ineligible, and b. has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (cd)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib). * france specific: participants have failed at least 4 prior lines of anti-myeloma therapies * participant has measurable disease per modified imwg criteria. * life expectancy of at least 6 months, in the opinion of the investigator. * male and female participants agree to abide by protocol-defined contraceptive requirements. * participant is capable of giving signed informed consent. * participant meets country-specific inclusion criteria described in the protocol. exclusion criteria: * symptomatic amyloidosis, active poems syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening. * current corneal epithelial disease, except nonconfluent superficial punctate keratitis (spk). * evidence of active mucosal or internal bleeding. * presence of an active renal condition. * any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures. * malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for \>2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (mm). participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. * evidence of cardiovascular risk as per the protocol criteria. * pregnant or lactating female. * active infection requiring antibiotic, antiviral, or antifungal treatment. * known human immunodeficiency virus (hiv) infection, unless the criteria in protocol can be met. * hepatitis b and c will be excluded unless the criteria in protocol can be met. * cirrhosis or current unstable liver or biliary disease. * alanine aminotransferase (alt) \>2.5× upper limit of normal (uln). * total bilirubin \>1.5×uln. * systemic anti-mm therapy within \<=14 days or 5 half-lives, whichever is shorter. * systemic therapy with high dose steroids within \<=14 days before the first dose of study treatment. * prior allogenic stem cell transplant. * prior treatment with a monoclonal antibody \<=30 days before the first dose of study treatment. use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as covid, may be permitted. * prior treatment with an anti-b cell maturation antigen (bcma) targeted therapy or hypersensitivity reactions to any components of the study treatment. * treatment with an antibody-drug conjugate. * participant has received any major surgery \<=4 weeks before the first dose of study treatment. an exception may be allowed for bone stabilizing surgery. * inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. absolute neutrophil count \ 500 milligram/gram (mg/g), e. estimated glomerular filtration rate (egfr) \<30 milliliter per minute per 1.73 meter square (ml/min/1.73m\^2). * uk specific: a. absolute neutrophil count \<1.5×10\^9/l, c. platelet count \<75×10\^9/l

Keywords: antibody drug conjugate belantamab mafodotin blenrep dreamm14 gsk2857916 alternative dosing relapsed or refractory multiple myeloma rrmm