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

April 13, 2021 updated by: Rennes University Hospital

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).

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens - médecine interne
      • Angers, France
        • CHU Angers
      • Avignon, France
        • Centre Hospitalier H.Duffaut - Avignon
      • Besancon, France
        • Hôpital Jean Minjoz - Besancon
      • Blois, France, 41016
        • Service de Médecine interne - Centre Hospitalier
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Bordeaux, France
        • BORDEAUX Bergonié
      • Bordeaux, France
        • Bordeaux Haut Leveque
      • Brest, France
        • Hôpital A.Morvan Brest
      • Caen, France
        • CHU caen
      • Caen, France
        • Centre F.Baclesse
      • Clamart, France
        • Hôpital d'Instruction des Armées PERCY
      • Clermont Ferrand, France
        • CHU Clermont Ferrand
      • Colmar, France
        • CH Colmar
      • Dijon, France
        • CH DIJON
      • Dunkerque, France
        • CHG Dunkerque
      • Grenoble, France
        • CH Grenoble
      • La Roche sur yon, France
        • CH La Roche sur Yon
      • Laval, France
        • CH Laval
      • Le Mans, France
        • Le Mans Victor Hugo
      • Lille, France
        • Hopital Claude Huriez
      • Saint Brieuc, France
        • Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie
      • Toulouse, France
        • CHU Toulouse Purpan
      • Toulouse, France
        • CHU Toulouse Rangueil
      • Vandoeuvre, France, 54511
        • Service d'Hématologie - Hôpital de Brabois
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • Rennes University Hospital
    • Pays De Loire
      • Nantes, Pays De Loire, France, 44000
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Monoclonal gammopathy of undetermined significance or Smoldering myeloma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MGUS or SMM
Patients with Monoclonal gammopathy of undetermined significance or smoldering myeloma
Genetic: Genetic study of DNA copies
Gene expression profiling, DNA copy number variation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Intergroupe Francophone du Myelome

Investigators

  • Principal Investigator: Olivier DECAUX, MD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2009

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (ESTIMATE)

March 3, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCB 2008-A01023-52
  • AFSSAPS B80894-60 (OTHER: AFSSAPS)
  • IFM 08-02 (OTHER: IFM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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