A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA) (EUREKA)

Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)

A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.

Study Overview

• Status: Recruiting
• Conditions: AL Amyloidosis

Detailed Description

In the frame of the EUREKA Consortium, a patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers across Europe or at their satellite sites will be created, in association with a cross-border biorepository and sample sharing network for the study of both disease-causing light chains and plasma cells with advanced molecular technologies. A dedicated site will support the Consortium with big data analysis and artificial intelligence applied to health. The aims are: 1) Defining the impact of advanced molecular technologies to promote early diagnosis and guide therapeutic choices; 2) describing the natural history of the disease in a representative cohort of AL patients in the contemporary era of effective anti-plasma cell therapies; 3) investigating and refining novel advanced technologies to detect with high sensitivity residual disease-causing plasma cells/light chains in patients achieving a complete hematologic response to therapy (minimal residual disease, MRD).

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Giovanni Palladini; Phone Number: +390382502994; Email: segreteria.amiloidosi@smatteo.pv.it

Study Locations

• Germany
  • Heidelberg, Germany
    • Recruiting
    • Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672
    • Contact: Stefan Schönland, MD
    • Principal Investigator: Stefan Schönland, MD
    • Sub-Investigator: Ute Hegenbart, MD
• Italy
  • Pavia, Italy
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100
    • Contact: Giovanni Palladini
    • Principal Investigator: Giovanni Palladini, MD, PhD
    • Sub-Investigator: Mario Ulisse Nuvolone, MD, PhD
• Netherlands
  • Utrecht, Netherlands
    • Recruiting
    • UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan
    • Contact: Monique Minnema, MD
    • Principal Investigator: Monique Minnema, MD
• Spain
  • Pamplona, Spain
    • Recruiting
    • Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra
    • Contact: Bruno Paiva, PhD
    • Principal Investigator: Bruno Paiva, PhD
• Switzerland
  • Muttenz, Switzerland
    • Active, not recruiting
    • University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics
• Uruguay
  • Montevideo, Uruguay
    • Recruiting
    • Universidad de la Republica Hospital de Clinicas "Dr Manuel Quintela"
    • Contact: Eloisa Riva, MD; Phone Number: +59819534637; Email: eriva@hc.edu.uy
    • Principal Investigator: Eloisa Riva, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

400 patients with AL amyloidosis will be enrolled at diagnosis and evaluated at any of the participating clinical centers.

Description

Inclusion Criteria:

• diagnosis of systemic AL amyloidosis;
• treatment-naïve;
• age ≥18 years;
• ability to understand and willingness to sign an informed consent;
• planned follow-up at participating center.

Exclusion Criteria:

• non-AL amyloidosis;
• previous treatment for AL amyloidosis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 24 months by stage	Mortality at 24 months by stage will be evaluated	24 months from diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of hematologic relapse in Complete Response patients at 2 years by MRD status	Rate of hematologic relapse in Complete Response patients at 2 years by MRD status will be evaluated	2 years from diagnosis

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Paraproteinemias; Proteostasis Deficiencies; Amyloidosis; Nutritional and Metabolic Diseases; Immunoglobulin Light-chain Amyloidosis
• Other Study ID Numbers: AC-021-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No