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

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.

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Key information

Conditions

AL Amyloidosis Abnormalities, Multiple Amyloidosis Blood Protein Disorders Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases POEMS Syndrome Paraproteinemias Peripheral Nervous System Diseases Polyneuropathies Proteostasis Deficiencies Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Mario Nuvolone

CONTACT

[email protected]

0382502935

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

identify sequence fingerprints in IGLV1-44 light chains leading to AL amyloidosis and POEMS syndrome

Time frame: two years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Nuvolone, MD

CONTACT

[email protected]

0382502935

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: ALPS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 4, 2026
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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