NCT06205953

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
6 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2024Jun 2026

Study Start

First participant enrolled

January 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

January 4, 2024

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality at 24 months by stage

    Mortality at 24 months by stage will be evaluated

    24 months from diagnosis

Secondary Outcomes (1)

  • Rate of hematologic relapse in Complete Response patients at 2 years by MRD status

    2 years from diagnosis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672

Heidelberg, Germany

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100

Pavia, Italy

RECRUITING

UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan

Utrecht, Netherlands

RECRUITING

Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra

Pamplona, Spain

RECRUITING

University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics

Muttenz, Switzerland

ACTIVE NOT RECRUITING

Universidad de la Republica Hospital de Clinicas "Dr Manuel Quintela"

Montevideo, Uruguay

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood, bone marrow aspirate, serum, plasma, urine, fat tissue.

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations