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

Study Overview
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Brief Summary
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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.

Official Title
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Large Scale Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From Monoclonal Gammopathy of Undetermined Significance (MGUS) and Indolent Myeloma (SMM).

Conditions
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Monoclonal Gammopathy of Undetermined Significance, Smoldering Myeloma

Intervention / Treatment
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* Genetic: Genetic study of DNA copies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MGUS or SMM<br>Patients with Monoclonal gammopathy of undetermined significance or smoldering myeloma | Genetic: Genetic study of DNA copies<br>* Gene expression profiling, DNA copy number variation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression to symptomatic multiple myeloma |  | Every 6 or 12 months during 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monoclonal gammopathy of undetermined significance, MGUS, Smoldering myeloma, SMM, Multiple myeloma