A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis (NCT05250973)
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: City of Hope โ Duarte, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (46 Sites)
Showing the first 25 of 46 sites.
- City of Hope โ Duarte, California
- Yale โ New Haven, Connecticut
- Moffitt Cancer Center โ Tampa, Florida
- Winship Cancer Institute Emory University โ Atlanta, Georgia
- Tufts Medical Center โ Boston, Massachusetts
- Boston University Medical Center โ Boston, Massachusetts
- Barbara Ann Karmanos Cancer Institute โ Detroit, Michigan
- Memorial Sloan Kettering โ New York, New York
- Levine Cancer Institute โ Charlotte, North Carolina
- Wake Forest University - Baptist Medical Center โ Winston-Salem, North Carolina
- University Hospital of Cleveland โ Cleveland, Ohio
- Ohio Health Research Institute โ Columbus, Ohio
- West Penn Hospital โ Pittsburgh, Pennsylvania
- UT Southwestern Medical Center โ Dallas, Texas
- VCU Medical Center โ Richmond, Virginia
- University of Washington โ Seattle, Washington
- Tom Baker Cancer Center โ Calgary, Alberta
- Cross Cancer Institute โ Edmonton, Alberta
- University Health Network UHN Princess Margaret Cancer Centre โ Toronto, Ontario
- Peking University First Hospital โ Beijing,
- Peking University People's Hospital โ Beijing,
- West China Hospital Si Chuan University โ Chengdu,
- First affiliated Hospital of Zhejiang University โ Hangzhou,
- Ruijin Hospital Shanghai Jiao Tong University โ Shanghai,
- CHU de Limoges โ Limoges,
๐ Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Amyloidosis
- Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant โ La Jolla, California
- A Study Of MCG In Cardiac Amyloidosis โ Rochester, Minnesota
- Dietary Reporting In The Amyloidoses โ Detroit, Michigan
- Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis โ Portland, Oregon
- A Study Of Myocardial Stiffness In Amyloidosis With Magnetic Resonance Elastography โ Rochester, Minnesota
Explore by condition: All Amyloidosis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.