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

Terminated

• Conditions: Monoclonal Gammopathy of Undetermined Significance; Smoldering Myeloma

• Registration Number: NCT01079429
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-12
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2014-01
• Study Completion: 2019-09
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression to symptomatic multiple myeloma	Every 6 or 12 months during 5 years

Trial Locations

Locations (27)

Rennes University Hospital; 🇫🇷 Rennes, Bretagne, 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; 🇫🇷 Besancon, France

Service de Médecine interne - Centre Hospitalier; 🇫🇷 Blois, France

Bordeaux Bergonié; 🇫🇷 Bordeaux, France

Bordeaux Haut Leveque; 🇫🇷 Bordeaux, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

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