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

March 1, 2010
December 24, 2013
November 2010
November 2018   (final data collection date for primary outcome measure)
Progression to symptomatic multiple myeloma [ Time Frame: Every 6 or 12 months during 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01079429 on ClinicalTrials.gov Archive Site
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Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood Plasma Urine Bone marrow

Non-Probability Sample

Patients with Monoclonal gammopathy of undetermined significance or Smoldering myeloma

  • Monoclonal Gammopathy of Undetermined Significance
  • Smoldering Myeloma
Genetic: Genetic study of DNA copies
Gene expression profiling, DNA copy number variation
MGUS or SMM
Patients with Monoclonal gammopathy of undetermined significance or smoldering myeloma
Intervention: Genetic: Genetic study of DNA copies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
November 2018
November 2018   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Oliver DECAUX, MD 33-2-9926-7128 olivier.decaux@chu-rennes.fr
France
 
NCT01079429
RCB 2008-A01023-52, AFSSAPS B80894-60, IFM 08-02
Yes
Rennes University Hospital
Rennes University Hospital
Intergroupe Francophone du Myelome
Principal Investigator: Olivier DECAUX, MD Rennes University Hospital
Rennes University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP