Monoclonal Gammopathy of Undetermined Significance, Smoldering Myeloma
Conditions
Keywords
Monoclonal gammopathy of undetermined significance, MGUS, Smoldering myeloma, SMM, Multiple myeloma
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.
Interventions
GENETICGenetic study of DNA copies
Gene expression profiling, DNA copy number variation
Sponsors
Intergroupe Francophone du Myelome
Rennes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression to symptomatic multiple myeloma | Every 6 or 12 months during 5 years |
Countries
France
Outcome results
None listed