How the IGLV1-44 light chain causes AL amyloidosis and POEMS
Official title: One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07448935 · Data updated 2026-11-12
This project tests whether specific IGLV1-44 light‑chain sequences drive AL amyloidosis and POEMS and whether nanobodies can recognize and stabilize those light chains in adults with AL amyloidosis, POEMS, or multiple myeloma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Status | Recruiting |
| Started | November 28, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT07448935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with biopsy‑proven systemic AL amyloidosis, POEMS syndrome, or multiple myeloma who agree to blood sampling and optional bone marrow aspiration are eligible.
✕Probably not a fit
Patients with non‑AL amyloidosis, undefined monoclonal gammopathy, or those already in complete hematologic response are unlikely to receive benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project collects blood (and optional bone marrow) from adults with biopsy‑proven AL amyloidosis, POEMS syndrome, or multiple myeloma to perform detailed sequence analysis and biophysical characterization of IGLV1-44 light chains. The team aims to identify sequence 'fingerprints' that distinguish light chains that cause cardiac proteotoxicity and POEMS manifestations. Findings are intended to improve risk stratification and earlier diagnosis for patients expressing pathogenic IGLV1-44 variants. Parallel laboratory work will develop and test nanobodies that recognize and stabilize pathogenic IGLV1-44 light chains as a possible starting point for future therapies.
Why it matters
Potential benefit: If successful, this work could enable earlier diagnosis and better risk prediction and provide a foundation for nanobody-based therapies that neutralize toxic IGLV1-44 light chains.
How similar studies have gone: Previous studies have linked IGLV1-44 sequence patterns to AL amyloidosis and POEMS, but using nanobodies to stabilize these light chains is largely preclinical and remains novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy Recruiting
Study contacts
- Study coordinator: Mario Nuvolone, MD
- Email: m.nuvolone@smatteo.pv.it
- Phone: 0382502935
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SMS text check-ins to track symptoms for people with plasma cell disorders
This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.
-
Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis
This study tests whether tec listamab plus daratumumab can help newly diagnosed multiple myeloma with AL amyloidosis and whether the combination is safe.
-
How N-glycosylation of light chains affects AL amyloidosis diagnosis and treatment
This project will test whether a sugar modification called N-glycosylation on immunoglobulin light chains helps cause disease or changes how AL amyloidosis and related monoclonal gammopathies behave in adults.
-
Registry and sample resource for patients with plasma cell disorders
This study is gathering information from patients with plasma cell disorders like multiple myeloma to see how to improve their treatment and quality of life.
-
6MW5311 in adults with relapsed or refractory blood cancers
This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.
-
Tailored exercise program to improve quality of life for adults with hematologic cancers
This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.