๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

๐Ÿฉบ 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

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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,

๐Ÿ“ž 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.

๐Ÿ’ฐ 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.

Explore by condition: All Amyloidosis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—