Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT06383143

Promoting Diagnosis and Management of AL in Italy (ProDigALIty)

Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2026-04-16

760

Participants Needed

4

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The investigators plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to: 1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM) 2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical/clinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy; 3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis

CONDITIONS

Official Title

Promoting Diagnosis and Management of AL in Italy (ProDigALIty)

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of MGUS with altered free light chain ratio or smoldering multiple myeloma
  • Treatment-na�efve patients
  • Age 18 years or older
  • Ability to understand and willingness to sign informed consent
  • Planned follow-up at participating center
  • Diagnosis of systemic AL amyloidosis
Not Eligible

You will not qualify if you...

  • Diagnosis of symptomatic monoclonal gammopathies
  • Previous treatment for monoclonal gammopathies
  • Non-AL amyloidosis
  • Previous treatment for AL amyloidosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Azienda Ospedaliera Policlinico Consorziale

Bari, Italy

Actively Recruiting

2

Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco

Catania, Italy

Actively Recruiting

3

Fondazione Irccs Policlinico San Matteo

Pavia, Italy

Actively Recruiting

4

EMATOLOGIA - Città della Scienza e Salute - Torino

Torino, Italy

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Promoting Diagnosis and Management of AL in Italy (ProDigALIty) | DecenTrialz