protocolSection identificationModule nctId: NCT06383143, orgStudyIdInfo id: AC-020-IT, briefTitle: Promoting Diagnosis and Management of AL in Italy (ProDigALIty), acronym: ProDigALIty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: IRCCS Policlinico S. Matteo, class: OTHER, descriptionModule briefSummary: We 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, conditionsModule conditions: AL Amyloidosis, conditions: Smoldering Multiple Myeloma, conditions: Monoclonal Gammopathy of Undetermined Significance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 760, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient, primaryOutcomes measure: 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., primaryOutcomes measure: 3. Identify associations of clonal light chain features with different clinical features at baseline., secondaryOutcomes measure: 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, secondaryOutcomes measure: Description of the baseline characteristics of MGUS/SMM patients with abnormal FLCR, secondaryOutcomes measure: Identification of clinical and biological correlates of hematological response, secondaryOutcomes measure: 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, secondaryOutcomes measure: Identification of associations of clonal light chain features with event-free survival, secondaryOutcomes measure: Validation of existing algorithms for predicting AL amyloidosis status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera Policlinico Consorziale, status: RECRUITING, city: Bari, country: Italy, contacts name: PELLEGRINO MUSTO, MD, role: CONTACT, phone: 080 5593471, email: ematologiacontrapianto@policlinico.ba.it, contacts name: PELLEGRINO MUSTO, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Angela Minervini, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco, status: RECRUITING, city: Catania, country: Italy, contacts name: Francesco Di Raimondo, MD, role: CONTACT, phone: 095/378.1956, email: segremat@unict.it, contacts name: Francesco Di Raimondo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Concetta Maria Sebastiana Conticello, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Fondazione Irccs Policlinico San Matteo, status: RECRUITING, city: Pavia, country: Italy, contacts name: GIOVANNI PALLADINI, MD, PhD, role: CONTACT, phone: +390382502994, email: segreteria.amiloidosi@smatteo.pv.it, contacts name: GIOVANNI PALLADINI, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Luca Arcaini, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mario Ulisse Nuvolone, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, locations facility: EMATOLOGIA - Città della Scienza e Salute - Torino, status: RECRUITING, city: Torino, country: Italy, contacts name: FRANCESCA MARIA GAY, MD, PhD, role: CONTACT, phone: 011.633.5550 - 5935, email: ematologia@cittadellasalute.to.it, contacts name: FRANCESCA MARIA GAY, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefania Oliva, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False