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

NCT07448935 | Recruiting

• 1 other identifier: ALPS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AL Amyloidosis; POEMS Syndrome; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

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

  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.

  two years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy-proven diagnosis of systemic AL amyloidosis, POEMS syndrome or multiple myeloma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis; POEMS Syndrome; Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mario Nuvolone, MD

CONTACT

0382502935; m.nuvolone@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: November 28, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

IT (1)