RecruitingNCT06383143

Promoting Diagnosis and Management of AL in Italy (ProDigALIty)

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

760 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

Monoclonal Gammopathy of Undetermined Significance Smoldering Multiple Myeloma AL Amyloidosis

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This Italian study is looking at people who are at risk for, or have been diagnosed with, a protein-buildup disease called AL amyloidosis — where abnormal proteins collect in organs and damage them. Researchers want to improve how this condition is diagnosed and managed earlier. **You may be eligible if...** - You are 18 or older - You have a pre-cancerous blood condition called MGUS with abnormal protein levels, or smoldering myeloma (Part A) - OR you have been newly diagnosed with systemic AL amyloidosis and have not yet started treatment (Part B) - You are able to attend follow-up visits at a participating center **You may NOT be eligible if...** - You already have a symptomatic blood cancer (like multiple myeloma with symptoms) - You have received previous treatment for your blood or protein condition - You have a different type of amyloidosis (not AL type) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.