HomeTrialNCT05250973
🔬NCT05250973Phase 2ACTIVE NOT RECRUITING

A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

Study Summary

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
View on ClinicalTrials.gov ↗
Study Details
Enrollment151 participants
Primary Completion
Lead SponsorJanssen Research & Development, LLC
Data Retrieved2026-04-11 02:55:31.550772+00:00
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