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
diagnosis of MGUS with altered FLCR or SMM;
treatment-naïve;
age ≥18 years;
ability to understand and willingness to sign an informed consent;
Diagnosis of symptomatic monoclonal gammopathies;
Previous treatment for monoclonal gammopathies.
diagnosis of systemic AL amyloidosis;
treatment-naïve;
The participating Departments of Hematology will be involved in screening at-risk patients with monoclonal gammopathies and refer suspected/confirmed AL cases to the Amyloidosis Center in Pavia.
Case-only
Prospective
no intervention
Other interventionno intervention
Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient
Part A of the study: the proportion of patients with newly diagnosed AL through the biomarker-based screening of at-risk patients with a known monoclonal gammopathy will be identified.
Assess the proportion of patients with deep haematological response after frontline therapy (best response evaluation) in the new enhanced, contemporary, real-world series of AL patients enrolled during the study.
Part B of the study: The proportion of patients with deep hematological response after frontline therapy will be assessed
3. Identify associations of clonal light chain features with different clinical features at baseline.
Part C of the study: Associations of clonal light chain features with different clinical features at baseline, including organ tropism and clonal burden, will be assessed.
Description of the baseline characteristics and 6-months outcome, as well as the time to AL development for patients with AL identified through the biomarker-based screening
Part A: the baseline characteristics and 6-months outcome, as well as the time to AL development for patients with AL identified through the biomarker-based screening will be evaluated
Description of the baseline characteristics of MGUS/SMM patients with abnormal FLCR
Part A: the baseline characteristics of MGUS/SMM patients with abnormal FLCR will be described
Identification of clinical and biological correlates of hematological response
part B: clinical and biological correlates of hematological response will be identified
To verify whether implementing a dedicated pipeline for referral of AL patients to the National Referral Center will increase the proportion of patients from spoke centers
Part B: it will be verified if implementing a dedicated pipeline for referral of AL patients to the National Referral Center will increase the proportion of patients from spoke centers
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