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

This study is ongoing, but not recruiting participants.
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: August 8, 2014
Last verified: August 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Rennes University Hospital
Rennes, Bretagne, France, 35000
Nantes University Hospital
Nantes, Pays de Loire, France, 44000
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, 41016
Bordeaux Bergonié
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Bordeaux Haut Leveque
Bordeaux, France
Hôpital A.Morvan Brest
Brest, France
CHU Caen
Caen, France
Centre F.Baclesse
Caen, France
Hôpital d'instruction des armées Percy
Clamart, France
CHU Clermont Ferrand
Clermont Ferrand, France
CH Colmar
Colmar, France
CH Dijon
Dijon, France
CHG Dunkerque
Dunkerque, France
CH Grenoble
Grenoble, France
CH La Roche sur yon
La Roche sur yon, France
CH Laval
Laval, France
Le Mans Victor Hugo
Le Mans, France
Hôpital Claude Huriez
Lille, France
Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie
Saint Brieuc, France
CHU Toulouse Purpan
Toulouse, France
CHU Toulouse Rangueil
Toulouse, France
Service d'Hématologie - Hôpital de Brabois
Vandoeuvre, France, 54511
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: August 8, 2014
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:
Multiple Myeloma
Neoplasms, Plasma Cell
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia

ClinicalTrials.gov processed this record on October 01, 2014