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

Key Information
Year
2024
summary/abstract
Brief 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).
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).
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Official Title
(AL) Amyloidosis
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Conditions
Amyloidosis
Amyloidosis
Intervention / Treatment
  • DrugDrug : Daratumumab
  • DrugDrug : Cyclophosphamide
  • DrugDrug : Bortezomib
  • DrugDrug : Dexamethasone
Other Study ID Numbers
  • CR109160
  • 2021-002639-48 ( EudraCT Number )
  • 54767414AMY2009 ( Other Identifier ) (OTHER: Janssen Research & Development, LLC)
  • 2023-507069-25-00 ( Registry Identifier ) (REGISTRY: EUCT number)
  • CR109160
  • 2021-002639-48 ( EudraCT Number )
  • 54767414AMY2009 ( Other Identifier ) (OTHER: Janssen Research & Development, LLC)
  • 2023-507069-25-00 ( Registry Identifier ) (REGISTRY: EUCT number)