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

This study is currently recruiting participants.
Verified December 2013 by Rennes University Hospital
Sponsor:
Collaborator:
Intergroupe Francophone du Myelome
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01079429
First received: March 1, 2010
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Monoclonal Gammopathy of Undetermined Significance
Smoldering Myeloma
Genetic: Genetic study of DNA copies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Progression to symptomatic multiple myeloma [ Time Frame: Every 6 or 12 months during 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood Plasma Urine Bone marrow


Estimated Enrollment: 1200
Study Start Date: November 2010
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Monoclonal gammopathy of undetermined significance or Smoldering myeloma

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079429

Contacts
Contact: Oliver DECAUX, MD 33-2-9926-7128 olivier.decaux@chu-rennes.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, Bretagne, France, 35000
Contact: Oliver DECAUX, Md    33-2-9926-7128    olivier.decaux@chu-rennes.fr   
Principal Investigator: Olivier DECAUX, MD         
Sub-Investigator: Bernard GROSBOIS, MD, PhD         
Sub-Investigator: Lucienne GUENET, MD         
Nantes University Hospital Recruiting
Nantes, Pays de Loire, France, 44000
Contact: Hervé AVET-LOISEAU, MD, PhD    33-2-4008-4034    herve.avetloiseau@chu-nantes.fr   
Principal Investigator: Hervé AVET-LOISEAU, MD, PhD         
Principal Investigator: Philippe MOREAU, MD, PhD         
Sub-Investigator: Stéphane MINVIELLE, MD         
CHU Amiens - médecine interne Recruiting
Amiens, France
Contact: Valérie Salle, MD         
Principal Investigator: Valérie Salle, MD         
CHU Angers Recruiting
Angers, France
Contact: Mamoun Dib, MD    00-2 41 35 44 72    secretariat-hemato@chu-angers.fr   
Principal Investigator: Mamoun Dib, MD         
Centre Hospitalier H.Duffaut - Avignon Recruiting
Avignon, France
Contact: Gérard Lepeu, MD    00-4.90.80.16.78    glepeu@ch-avignon.fr   
Principal Investigator: Gérard Lepeu, MD         
Hôpital Jean Minjoz - Besancon Recruiting
Besancon, France
Contact: Jean Fontan, MD    00-3.81.66.82.32      
Principal Investigator: Jean Fontan, MD         
Service de Médecine interne - Centre Hospitalier Recruiting
Blois, France, 41016
Contact: Philippe RODON, MD       prodon@ch-blois.rss.fr   
Principal Investigator: Philippe RODON, MD         
Bordeaux Bergonié Recruiting
Bordeaux, France
Contact: Gabriel Etienne, MD    00-5.56.33.33.33      
Principal Investigator: Gabriel Etienne, MD         
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France
Contact: Olivier Fitoussi, MD         
Principal Investigator: Olivier Fitoussi, MD         
Bordeaux Haut Leveque Recruiting
Bordeaux, France
Contact: Gérald Marit, MD PhD    00-5.56.55.65.1    gerald.marit@chu-bordeaux.fr   
Principal Investigator: Gérald Marit, MD PhD         
Hôpital A.Morvan Brest Recruiting
Brest, France
Contact: Christian Berthou, MD PhD         
Principal Investigator: Christian Berthou, MD PhD         
Centre F.Baclesse Recruiting
Caen, France
Contact: Jean Pierre Vilque, MD         
Principal Investigator: Jean Pierre Vilque, MD         
CHU Caen Recruiting
Caen, France
Contact: Margaret Macro, MD         
Principal Investigator: Margaret Macro, MD         
Hôpital d'instruction des armées Percy Recruiting
Clamart, France
Contact: Thierry De Revel, MD PhD         
Principal Investigator: Thierry De Revel, MD PhD         
CHU Clermont Ferrand Recruiting
Clermont Ferrand, France
Contact: Carine CHALETEIX, MD         
Principal Investigator: Carine CHALETEIX, MD         
CH Colmar Recruiting
Colmar, France
Contact: Bruno AUDHUY, MD         
Principal Investigator: Bruno AUDHUY, MD         
CH Dijon Recruiting
Dijon, France
Contact: Denis CAILLOT, MD         
Principal Investigator: Denis CAILLOT, MD         
CHG Dunkerque Recruiting
Dunkerque, France
Contact: Marc WETTERWALD, MD         
Principal Investigator: Marc WETTERWALD, MD         
CH Grenoble Recruiting
Grenoble, France
Contact: Brigitte PEGOURIE, MD         
Principal Investigator: Brigitte PEGOURIE, MD         
CH La Roche sur yon Recruiting
La Roche sur yon, France
Contact: Hervé MAISONNEUVE, MD         
Principal Investigator: Hervé Maisonneuve, MD         
CH Laval Recruiting
Laval, France
Contact: Dominique JACOMY, MD         
Principal Investigator: Dominique JACOMY, MD         
Le Mans Victor Hugo Recruiting
Le Mans, France
Contact: Eric VOOG, MD         
Principal Investigator: Eric VOOG, MD         
Hôpital Claude Huriez Recruiting
Lille, France
Contact: Thierry Facon, MD PhD         
Principal Investigator: Thierry Facon, MD PhD         
Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie Recruiting
Saint Brieuc, France
Contact: Benoît Bareau, MD         
Principal Investigator: Benoît Bareau, MD         
CHU Toulouse Purpan Recruiting
Toulouse, France
Contact: Michel Attal, MD PhD    00-5.61.77.20.78    attal.m@chu-toulouse.fr   
Principal Investigator: Michel Attal, MD PhD         
CHU Toulouse Rangueil Active, not recruiting
Toulouse, France
Service d'Hématologie - Hôpital de Brabois Recruiting
Vandoeuvre, France, 54511
Contact: Cyrille HULIN, MD       c.hulin@chu-nancy.fr   
Principal Investigator: Cyrille HULIN, MD         
Sponsors and Collaborators
Rennes University Hospital
Intergroupe Francophone du Myelome
Investigators
Principal Investigator: Olivier DECAUX, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01079429     History of Changes
Other Study ID Numbers: RCB 2008-A01023-52, AFSSAPS B80894-60, IFM 08-02
Study First Received: March 1, 2010
Last Updated: December 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Monoclonal gammopathy of undetermined significance
MGUS
Smoldering myeloma
SMM
Multiple myeloma

Additional relevant MeSH terms:
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on April 17, 2014