Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
Fondazione IRCCS Policlinico San Matteo di Pavia
760 participants
May 1, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria11
- PART A
- 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.
- 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 Criteria5
- Diagnosis of symptomatic monoclonal gammopathies;
- Previous treatment for monoclonal gammopathies.
- PART B
- non-AL amyloidosis;
- previous treatment for AL amyloidosis.
Interventions
no intervention
Locations(4)
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NCT06383143