A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) (NCT04504825)
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis
🩺 Plain-English Summary (8th-Grade Level)
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.
Who can join: Review the eligibility criteria below.
Location: Research Site — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (90 Sites)
Showing the first 25 of 90 sites.
- Research Site — Duarte, California
- Research Site — Palo Alto, California
- Research Site — San Francisco, California
- Research Site — Weston, Florida
- Research Site — Indianapolis, Indiana
- Research Site — New Orleans, Louisiana
- Research Site — Boston, Massachusetts
- Research Site — Boston, Massachusetts
- Research Site — Boston, Massachusetts
- Research Site — Detroit, Michigan
- Research Site — Rochester, Minnesota
- Research Site — St Louis, Missouri
- Research Site — New York, New York
- Research Site — New York, New York
- Research Site — Rochester, New York
- Research Site — Winston-Salem, North Carolina
- Research Site — Cleveland, Ohio
- Research Site — Columbus, Ohio
- Research Site — Portland, Oregon
- Research Site — Philadelphia, Pennsylvania
- Research Site — Nashville, Tennessee
- Research Site — Dallas, Texas
- Research Site — Houston, Texas
- Research Site — Salt Lake City, Utah
- Research Site — Seattle, Washington
💰 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 § 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 AL Amyloidosis
- Ixazomib Maintenance Study in Patients With AL Amyloidosis — Boston, Massachusetts
- Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial — Scottsdale, Arizona
- Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis — Boston, Massachusetts
- Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis — Orange, California
- A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement — Palo Alto, California
Explore by condition: All AL Amyloidosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.