Clinical trial · Observational
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Monoclonal Gammopathy of Undetermined Significance | Monoclonal Gammopathy of Undetermined Significance | ONTOLOGY_EXACT | 0.98 |
| Smoldering Multiple Myeloma | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with MGUS and aFLCR and with SMM
- description
- Part A: Patients with MGUS and aFLCR and patients with SMM undergoing an active, biomarker-based screening of presymptomatic amyloid organ involvement. Part B: Newly diagnosed patients with AL amyloidosis identified through Part A or with clinically overt AL amyloidosis evaluated in the frame of routine clinical assessments and referred to the Amyloidosis Research and Treatment Center in Pavia or managed locally at the participating Italian Hematologic Departments
- interventionNames
- Other: no intervention
Primary outcomes (3)
- measure
- Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient
- timeFrame
- 2 years
- description
- 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.
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available