Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.

NCT ID: NCT01079429

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-12
• Study Completion Date: 2019-09-30

Brief Summary

The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for correlations with the risk of progression in order to establish a predictive model of early malignant transformation.

Conditions

Monoclonal Gammopathy of Undetermined Significance; Smoldering Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MGUS or SMM

Patients with Monoclonal gammopathy of undetermined significance or smoldering myeloma

Genetic study of DNA copies

Intervention Type: GENETIC

Gene expression profiling, DNA copy number variation

Interventions

Genetic study of DNA copies

Gene expression profiling, DNA copy number variation

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• Patients aged from 18 to 70 years
• Written informed consent
• One of the following three criteria:

• Recently diagnosed IgG or IgA monoclonal gammopathy without clinical or biological features of malignant hemopathy
• IgG or IgA MGUS regardless the date of the diagnosis
• SMM regardless the date of the diagnosis
• Normal blood count, creatininemia and calcemia *
• Bence-Jones proteinuria below 1g/24 hours
• Absence of bone pain
• No clinical or biological features of amyloidosis
• No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) * In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)

Diagnostic criteria for MGUS:

• Monoclonal component concentration below 30 g / l AND
• Bone marrow plasmacytosis below 10%
• Bence-Jones proteinuria below 1g/24 hours
• Normal blood count, creatininemia and calcemia *
• Absence of bone lesions on conventional bone radiographies
• No clinical or biological features of amyloidosis
• Absence of hyperviscosity syndrome
• No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) * In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)

Diagnostic criteria for SMM:

• Monoclonal component concentration greater than 30 g / l AND / OR
• Bone marrow plasmacytosis greater than 10%
• Bence-Jones proteinuria below 1g/24 hours
• Normal blood count, creatininemia and calcemia *
• Absence of bone lesions on conventional bone radiographies
• No clinical or biological features of amyloidosis
• Absence of hyperviscosity syndrome
• No recurrent episode of infection (more than 2 infections requiring antibiotics in the previous 6 months) * In case of abnormal blood count, renal failure or hypercalcemia, patients may be included if an intercurrent cause is identified (for example anemia associated with iron deficiency)

Exclusion Criteria

• Patients younger than 18 years
• Patients older than 71 years
• IgM monoclonal gammopathy (regardless of diagnosis)
• Monoclonal gammopathy associated with hematologic malignancies (multiple myeloma, chronic lymphocytic leukemia, ...)
• Patients with chronic liver disease, autoimmune or neoplastic disease for less than 5 years
• Active viral hepatitis B or C
• HIV seropositive patient
• Pregnant woman
• Breastfeeding woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intergroupe Francophone du Myelome

NETWORK

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier DECAUX, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, Brittany Region, France

Nantes University Hospital

Nantes, Pays de Loire, France

CHU Amiens - médecine interne

Amiens, , France

CHU Angers

Angers, , France

Centre Hospitalier H.Duffaut - Avignon

Avignon, , France

Hôpital Jean Minjoz - Besancon

Besançon, , France

Service de Médecine interne - Centre Hospitalier

Blois, , France

Bordeaux Bergonié

Bordeaux, , France

Bordeaux Haut Leveque

Bordeaux, , France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Hôpital A.Morvan Brest

Brest, , France

Centre F.Baclesse

Caen, , France

CHU Caen

Caen, , France

Hôpital d'instruction des armées Percy

Clamart, , France

CHU Clermont Ferrand

Clermont-Ferrand, , France

CH Colmar

Colmar, , France

CH Dijon

Dijon, , France

CHG Dunkerque

Dunkirk, , France

CH Grenoble

Grenoble, , France

CH La Roche sur yon

La Roche-sur-Yon, , France

CH Laval

Laval, , France

Le Mans Victor Hugo

Le Mans, , France

Hôpital Claude Huriez

Lille, , France

Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie

Saint-Brieuc, , France

CHU Toulouse Purpan

Toulouse, , France

CHU Toulouse Rangueil

Toulouse, , France

Service d'Hématologie - Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

AFSSAPS B80894-60

Identifier Type: OTHER

Identifier Source: secondary_id

IFM 08-02

Identifier Type: OTHER

Identifier Source: secondary_id

RCB 2008-A01023-52

Identifier Type: -

Identifier Source: org_study_id