Promoting Diagnosis and Management of AL in Italy (ProDigALIty)

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Apr 19, 2024

Keywords

ClinConnect Summary

The ProDigALIty trial is investigating ways to improve the early diagnosis and management of AL amyloidosis, a condition where harmful proteins build up in the body. The study aims to create a network of hematology departments in Italy that will work together with a specialized research center in Pavia. This network will help identify at-risk patients—like those with certain blood conditions such as monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM)—and facilitate their enrollment in clinical studies. The trial will also explore new diagnostic methods to better understand and detect AL amyloidosis.

To participate in this trial, individuals must be at least 18 years old and either have a diagnosis of MGUS with an altered free light chain ratio (FLCR) or smoldering multiple myeloma, or be newly diagnosed with systemic AL amyloidosis without prior treatment. Participants will be asked to sign an informed consent and will be monitored at one of the participating centers. This study is currently recruiting participants and aims to ensure that a diverse group of patients is represented, which could lead to better understanding and treatment options for AL amyloidosis in Italy.

Gender

ALL

Eligibility 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.