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Recruiting NCT07448935

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

Observational AL Amyloidosis POEMS Syndrome Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: AL Amyloidosis, POEMS Syndrome, Multiple Myeloma. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • identify sequence fingerprints in IGLV1-44 light chains leading to AL amyloidosis and POEMS syndrome [Time frame: two years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione IRCCS Policlinico San Matteo — Pavia

Identifiers

NCT: NCT07448935 · ALPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗