Clinical Research Directory

Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis

Sponsor: Regeneron Pharmaceuticals

Summary

This study is researching a Regeneron drug called linvoseltamab ("study drug") alone compared to standard of care (SoC) combination to see if it can help treat participants who are newly diagnosed and previously untreated for systemic amyloid light-chain (AL) amyloidosis. The aim of this study is to see if the safety and efficacy of linvoseltamab alone can deliver better disease control and outcomes than Dara-VCd. The study is looking at: * What side effects linvoseltamab alone might cause * How well linvoseltamab works compared to Dara-VCd regimen in terms of reductions of the abnormal proteins that cause AL-amyloidosis that affects the heart and kidney functions and for how long * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)

Official title: An Open-Label, Randomized Phase 3 Trial of Linvoseltamab Compared With Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Participants With Newly Diagnosed Systemic Light Chain Amyloidosis

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