Trials / Active Not Recruiting
Active Not RecruitingNCT05250973
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daratumumab | Daratumumab will be administered subcutaneously. |
| DRUG | Cyclophosphamide | Cyclophosphamide will be administered either orally or IV. |
| DRUG | Bortezomib | Bortezomib will be administered by SC injection or IV. |
| DRUG | Dexamethasone | Dexamethasone will be administered orally or IV. |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2025-05-30
- Completion
- 2026-10-22
- First posted
- 2022-02-22
- Last updated
- 2026-04-13
Locations
46 sites across 10 countries: United States, Canada, China, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05250973. Inclusion in this directory is not an endorsement.