- A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis — Active Not Recruiting • Phase II • Cardiology / Cardiovascular • NCT05250973.
- Trial testing a new drug combination for heart-involved amyloid disease, comparing immediate versus delayed treatment timing.
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The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2). Conditions: Amyloidosis Interventions: Daratumumab, Cyclophosphamide, Bortezomib,…