NCT07448935 One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS
| NCT ID | NCT07448935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | AL Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-11-28 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
By detailed sequence analysis and subsequent biophysical characterization of prototypic light chains, this project aims to identify sequence fingerprints in IGLV1-44 light chains leading to AL amyloidosis and POEMS syndrome. This understanding might help improve the risk stratification and early diagnosis of patients overexpressing pathologic IGLV1-44 LCs. Moreover, the development of nanobodies efficient in recognizing and stabilizing IGLV1-44 light chains which exert direct toxicity in cardiac AL amyloidosis and POEMS syndrome might form the basis for future development of therapeutic agents capable of counteracting IGLV1-44 light chain proteotoxicity.
Eligibility Criteria
Inclusion Criteria: * Biopsy-proven diagnosis of systemic AL amyloidosis, POEMS syndrome or multiple myeloma * Planned peripheral blood sampling +/- bone marrow aspiration * Age \> 18 years * Willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes through signing a written informed consent. Exclusion Criteria: * Undefined monoclonal gammopathy or non-AL amyloidosis * Patients fulfilling the criteria for complete hematologic response after anti-clonal therapy * Age \<18 years * Failure to show willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07448935 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying AL Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07448935 currently recruiting?
Yes, NCT07448935 is actively recruiting participants. Contact the research team at m.nuvolone@smatteo.pv.it for enrollment information.
Where is the NCT07448935 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07448935 clinical trial?
NCT07448935 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 100 participants.