Familial Dysglobulinemia

Not Applicable

Completed

• Conditions: Dysglobulinemia

• Registration Number: NCT02853214
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no lifestyle or environmental exposure factors have been identified that are consistently linked to increased risk of MM, MGUS or the transition between the two.

The overall goal is to identify risk genes for dysglobulinemia, and more specifically Multiple Myeloma. This will involve the conservation of cells in a bank and genetic sequencing on samples obtained from families with at least two cases of dysglobulinemia. Material used for sequencing is likely to include fresh peripheral blood cells or lymphoblastoid lines established from peripheral blood lymphocytes of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-06
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1868

Inclusion Criteria

• 2 cases per family at least
• 1 case alive at least
• biological material available for 1 case at least
• Patients give their informed consent
• attached to the French Health protection service

Exclusion Criteria

• Age under 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Data of a bank cells, clinically annotated, from families with at least 2 cases of dysglobulinemia and at least 1 case alive.plasma cell dysplasia	up to 48 months	The investigator collects blood samples from patients with dysglobulinemia and their relatives and with this, the investigators constitutes the bank cells thanks to the establishment of lymphoblastoid cell lines.; The investigator considers as "dysglobulinemia" cases patients with Multiple Myeloma, MGUS, Waldenström's disease and MGUS (monoclonal gammopathy of unknown significance ) as wells as plasmacytomas confirmed histologically or cytologically.

Secondary Outcome Measures

Name	Time	Method
Single Nucleotide Polymorphism array for identification of polymorphisms predictive of dysglobulinemia	at day 0	The biological material, obtained from fresh peripheral blood cells and from Lymphoblastoid cells lines, is used for pangenic sequencing. It allows to better understand the mechanism of genetic variations who could be involve in the myeloma genesis

Trial Locations

Locations (47)

Service d'Oncologie-Radiothérapie - CHU Pointe-à-Pitre/Abymes Guadeloupe; 🇫🇷 Pointe à Pitre, Guadeloupe, France

Service de Médecine Interne-Hématologie, CHU de Fort de France Fort de France; 🇫🇷 Fort-de-France, Martinique, France

CHU d'ABBEVILLE; 🇫🇷 Abbeville, France

CHU Amiens Picardie; 🇫🇷 Amiens, France

CHU Groupe Hospitalier Sud Hématologie Clinique; 🇫🇷 Amiens, France

CH d'Avignon; 🇫🇷 Avignon, France

CHU de Besançon; 🇫🇷 Besançon, France

CH de Blois Service d'Hématologie; 🇫🇷 Blois, France

Hôpital Avicenne Service d'Hématologie; 🇫🇷 Bobigny, France

Service d'Hématologie clinique et Thérapie Cellulaire, CHU de BORDEAUX; 🇫🇷 Bordeaux, France

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