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NCT06383143: ProDigALIty
Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
trial testing no intervention in AL Amyloidosis in 760 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 760 |
| Start date | 1 May 2023 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 May 2026 |
| Sites | 4 locations across Italy |
Drugs / interventions tested
- no intervention
Conditions studied
- AL Amyloidosis — all drugs for AL Amyloidosis →
- Smoldering Multiple Myeloma — all drugs for Smoldering Multiple Myeloma →
- Monoclonal Gammopathy of Undetermined Significance — all drugs for Monoclonal Gammopathy of Undetermined Significance →
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Who can join
Adults 18 to 99, any sex, with AL Amyloidosis or Smoldering Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Feasibility of a Biomarker-Based Screening for Pre-Symptomatic AL Amyloidosis in Patients With Intermediate/High-Risk MGUS.
Mangiacavalli S, Milani P, Cartia CS, Varettoni M, et al · · 2025 · cited 3× · PMID 39627959 · DOI 10.1002/ajh.27545 -
Eligibility criteria for clinical trials in AL amyloidosis result in exclusion of nearly half of real-world patients.
Bellofiore C, Basset M, Nuvolone M, Nanci M, et al · · 2026 · PMID 41704548 · DOI 10.1002/hem3.70320
Verify or expand the search:
- PubMed search for NCT06383143
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for AL Amyloidosis
Currently open trials in the same condition.
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Other Fondazione IRCCS Policlinico San Matteo di Pavia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06383143 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Policlinico San Matteo di Pavia
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06383143.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing