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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01079429
Recruitment Status : Active, not recruiting
First Posted : March 3, 2010
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Intergroupe Francophone du Myelome
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Monoclonal Gammopathy of Undetermined Significance Smoldering Myeloma Genetic: Genetic study of DNA copies

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Study Type : Observational
Estimated Enrollment : 1200 participants
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).
Actual Study Start Date : January 12, 2009
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : September 2019


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




Primary Outcome Measures :
  1. Progression to symptomatic multiple myeloma [ Time Frame: Every 6 or 12 months during 5 years ]

Biospecimen Retention:   Samples With DNA
Whole blood Plasma Urine Bone marrow


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079429


Locations
Show Show 27 study locations
Sponsors and Collaborators
Rennes University Hospital
Intergroupe Francophone du Myelome
Investigators
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Principal Investigator: Olivier DECAUX, MD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01079429    
Other Study ID Numbers: RCB 2008-A01023-52
AFSSAPS B80894-60 ( Other Identifier: AFSSAPS )
IFM 08-02 ( Other Identifier: IFM )
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Keywords provided by Rennes University Hospital:
Monoclonal gammopathy of undetermined significance
MGUS
Smoldering myeloma
SMM
Multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
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
Precancerous Conditions