ClinicalTrials.gov record NCT07448935

One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age18 years old to 99 years old

SexAll

LocationItaly

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study collects blood (and possibly bone marrow) to analyze IGLV1-44 light-chain sequences and their biophysical properties. It is for people with biopsy-proven AL amyloidosis, POEMS syndrome, or multiple myeloma. The project also includes work to develop nanobodies that recognize and stabilize IGLV1-44 light chains.

What it is studying. The study tests whether specific sequence 'fingerprints' in IGLV1-44 light chains are associated with AL amyloidosis and POEMS syndrome by detailed sequence analysis and biophysical characterization. It also aims to develop nanobodies that recognize and stabilize IGLV1-44 light chains that exert direct toxicity (particularly in the heart, in cardiac AL amyloidosis), which the record says might form the basis for future therapeutic development.

What the researchers hope to learn. Identify sequence fingerprints in IGLV1-44 light chains linked to AL amyloidosis and POEMS; potentially improve risk stratification and early diagnosis for people overexpressing pathologic IGLV1-44 light chains; develop nanobodies that recognize and stabilize IGLV1-44 light chains as a basis for future therapeutic development.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will give peripheral blood samples and may be asked to undergo a bone marrow aspiration. The study team will use your clinical data and leftover diagnostic specimens (with your consent) for detailed light‑chain sequence analysis and biophysical characterization. No experimental treatment is assigned; this is observational research.

How the study is structured. A prospective observational cohort study. Participants provide blood samples and possibly a bone marrow aspiration; researchers perform sequence analysis and biophysical tests on collected light chains and follow results over time (primary outcome measured over two years). No experimental treatment is assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Nov 28, 2025
Primary completion: Jun 30, 2026 (estimated)
Study completion: Jun 30, 2026 (estimated)
Target enrollment: 100 participants (estimated)
Last updated on registry: May 6, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Principal investigator: Mario Nuvolone, Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Mario Nuvolone, MD 📞 0382502935 ✉ m.nuvolone@smatteo.pv.it

Participating sites (1)

Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, 27100 · Italy
- Mario Nuvolone · 0382502935 · m.nuvolone@smatteo.pv.it

Terms used on this page · explanations by MedicalUpdates.ai

Biopsy-proven: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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