drugset / Trial / NCT05250973
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2022-03-01
- Primary completion
- 2026-02-04
- Completion
- 2026-10-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Oral |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |