A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Status:
Not yet recruiting
Trial end date:
2025-11-18
Target enrollment:
Participant gender:
Summary
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide,
Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + 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).