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 June 2012 by Rennes University Hospital
Sponsor:
Rennes University Hospital
Collaborator:
Intergroupe Francophone du Myelome
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01079429
First received: March 1, 2010
Last updated: June 25, 2012
Last verified: June 2012
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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:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Deoxyribonucleic acid
U.S. FDA Resources
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: | June 25, 2012 |
| 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 May 16, 2013