The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
Participant is at least 18 years of age or the legal age of consent
Presence of an amyloid-related systemic syndrome as per consensus guidelines.
Positive amyloid staining by Congo red stain with green birefringence on polarized light microscopy in any tissue AND at least 1 of the following tests to confirm amyloid type as AL Characteristic appearance by electron microscopy or confirmatory immunohistochemistry or AL amyloidosis typing by mass spectrometric proteomic analysis of the amyloid deposits or amyloid-typing by immunofluorescence oEvidence of a monoclonal plasma cell proliferative disorder
Serum monoclonal protein >=0.5 grams per deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation performed at central laboratory),
Has a previous or current diagnosis of plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome or symptomatic multiple myeloma (MM), as per International Myeloma Working Group criteria for MM including the presence of lytic bone disease , plasmacytomas, or clonal BM plasma cells >=60%.
Has Immunoglobulin M (IgM)-related AL amyloidosis.
Has any form of non-AL amyloidosis, including wild type or mutated (Transthyretin amyloidosis [ATTR]) amyloidosis.
New York Heart Association (NYHA) classification IIIb or IV heart failure.
Sequential
Belantamab mafodotin
DrugBelantamab mafodotin will be administered
Cyclophosphamide
DrugCyclophosphamide will be administered
Bortezomib
DrugBortezomib will be administered
Dexamethasone
DrugDexamethasone will be administered
Overall complete hematologic response (CHR) rate
The overall CHR rate is defined as the proportion of participants who achieve a CHR during or after study treatment initiation, as assessed by the investigator, according to the consensus guidelines for AL amyloidosis.
Number of participants with non-serious adverse events and serious adverse events
Number of participants with clinically significant changes in hematology, and chemistry parameters
Number of participants with ocular findings on ophthalmic examination
Organ response rate (OrRR)
OrRR is defined as the proportions of participants who achieve confirmed organ response (cardiac, renal, or liver) in each organ as per consensus guidelines.
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