ClinicalTrials.gov record NCT07448779

Investigating the Pathogenic Role of N-glycosylation in AL Amyloidosis: Molecular Bases, Diagnosis, and Treatment

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

Investigating the Pathogenic Role of N-glycosylation in AL Amyloidosis: Molecular Bases, Diagnosis, and Treatment

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 is a prospective observational study of treatment‑naïve people with AL amyloidosis or other monoclonal gammopathies. It collects blood (and sometimes bone marrow) and clinical data to generate full-length immunoglobulin light-chain sequences and related information. The study examines the molecular role of light-chain N-glycosylation and its links to diagnosis, clinical features, and plasma-cell biology.

What it is studying. Whether and how N-glycosylation of immunoglobulin light chains relates to amyloid formation, affects laboratory assays and diagnostic typing, and associates with plasma-cell biology and drug sensitivity; also builds a clinically annotated dataset of full-length light-chain sequences.

What the researchers hope to learn. Create a large, clinically annotated dataset of full-length light-chain sequences; identify clinical features linked to light-chain N-glycosylation and its effects on diagnostic assays; improve sequence-based prediction of light-chain amyloidogenicity; study biological and pharmacologic differences between glycosylated and unglycosylated light chains.

What this study is about

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

Immunoglobulin light chain (AL) amyloidosis is caused by a typically small, minimally proliferating bone marrow plasma cell clone secreting a patient-unique, unstable, aggregation-prone, toxic light chain (LC). The amyloidogenicity of LCs is encrypted in their sequence, yet molecular determinants of LC pathogenicity remain obscure. N-glycosylation has been long suspected to be a determinant of LC amyloidogenicity based on anecdotal reports of individual AL patients with a clonal LC displaying this post-translational modification. It is hypothesized that N-glycosylation fundamentally contributes to determining the amyloidogenicity of immunoglobulin LCs in a subset of patients with AL and might influence its clinical phenotype. It is further proposed that the synthesis and secretion of unstable LCs that also have to be N-glycosylated might reverberate on the biology of the plasma cell clone, possibly modulating the sensitivity toward different drugs and might represent itself a therapeutic target. The objective of our study is now to elucidate the molecular role of LC N-glycosylation in AL amyloidosis, exploit it for risk assessment, and define its potential impact on the biology of the underlying plasma cell clone and its drug sensitivity.

Eligibility

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

Inclusion criteria

  • Diagnosis of monoclonal gammopathy (e.g. AL amyloidosis, MGUS, MM, others)
  • 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

  • Lack of monoclonal gammopathy
  • 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.

You would sign written informed consent to allow use of your medical records and leftover diagnostic specimens for research. The study will collect peripheral blood samples, and some people may also have a bone marrow aspiration if that is planned. Collected samples and clinical data will be used for laboratory analyses such as sequencing of immunoglobulin light chains and molecular studies of the plasma cell clone.

How the study is structured. A prospective observational cohort: participants give blood samples (and optionally bone marrow), clinical data and diagnostic leftovers are used for research, full-length light-chain sequencing and clinical annotation are performed, and investigators compare cases with and without N-glycosylation to study clinical and biological correlations.

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 17, 2025
Primary completion
May 30, 2027 (estimated)
Study completion
May 30, 2027 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Mar 4, 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
Alice Nevone, Alice Nevone
Fondazione IRCCS Policlinico San Matteo di Pavia

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

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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