Clinical trial Recruiting at 4 sites Observational Ages 18 to 99

Network for early diagnosis and management of AL amyloidosis in Italy

Official title: Promoting Diagnosis and Management of AL in Italy (ProDigALIty)

Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06383143 · Data updated 2026-11-12

This study is trying to set up a network in Italy to help doctors find AL amyloidosis earlier in patients who are at risk, so they can get treatment sooner and improve their health.

More AL Amyloidosis trials

Quick facts

Study typeObservational
Ages18 Years to 99 Years
SexAll
Enrollment760 (estimated)
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Academic / other
Locations4 sites (Bari and 3 other locations)
StatusRecruiting
StartedMay 1, 2023
Main results expectedMay 1, 2026
Study endsMay 1, 2026
Registry record updatedApril 16, 2026
Trial IDNCT06383143 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with a diagnosis of MGUS with altered free light chain ratio or smoldering multiple myeloma, as well as treatment-naïve patients with systemic AL amyloidosis.

Probably not a fit

Patients with symptomatic monoclonal gammopathies or those who have previously received treatment for AL amyloidosis will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This initiative aims to create a network of Italian Hematologic Departments linked to the Amyloidosis Research and Treatment Center in Pavia. It focuses on implementing a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis in at-risk patients, including those with monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. The project also seeks to facilitate patient referrals for ongoing clinical studies and to explore novel diagnostic technologies. By addressing the late diagnosis of AL amyloidosis, the study aims to improve patient outcomes through timely intervention.

Why it matters

Potential benefit: If successful, this initiative could lead to earlier diagnosis and better management of AL amyloidosis, potentially improving survival rates.

How similar studies have gone: While the approach of establishing a dedicated network for early diagnosis is innovative, similar studies have shown promise in improving outcomes for patients with rare diseases through early intervention.

Who can join: the full rules

Show full inclusion / exclusion criteria
PART A

Inclusion Criteria:

* diagnosis of MGUS with altered FLCR or SMM;
* treatment-naïve;
* age ≥18 years;
* ability to understand and willingness to sign an informed consent;
* planned follow-up at participating center.

Exclusion Criteria:

* Diagnosis of symptomatic monoclonal gammopathies;
* Previous treatment for monoclonal gammopathies.

PART B

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.

Where it's running

  • Azienda Ospedaliera Policlinico Consorziale
    Bari, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco
    Catania, Italy
    Recruiting
  • Fondazione Irccs Policlinico San Matteo
    Pavia, Italy
    Recruiting
  • EMATOLOGIA - Città della Scienza e Salute - Torino
    Torino, Italy
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.