Clinical trial NCT01079429: Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.
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).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Monoclonal Gammopathy of Undetermined Significance
Smoldering Myeloma
Keywords: Monoclonal gammopathy of undetermined significance
MGUS
Smoldering myeloma
SMM
Multiple myeloma
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Intergroupe Francophone du Myelome
First posted: 2010-03-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Monoclonal gammopathy of undetermined significance or Smoldering myeloma

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.


Eligibility 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

Primary outcomes:
measure: Progression to symptomatic multiple myeloma
timeFrame: Every 6 or 12 months during 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
city: Nantes
country: France
facility: Nantes University Hospital
state: Pays De Loire
city: Amiens
country: France
facility: CHU Amiens - médecine interne
city: Angers
country: France
facility: CHU Angers
city: Avignon
country: France
facility: Centre Hospitalier H.Duffaut - Avignon
city: Besancon
country: France
facility: Hôpital Jean Minjoz - Besancon
city: Blois
country: France
facility: Service de Médecine interne - Centre Hospitalier
city: Bordeaux
country: France
facility: Bordeaux Bergonié
city: Bordeaux
country: France
facility: Bordeaux Haut Leveque
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Brest
country: France
facility: Hôpital A.Morvan Brest
city: Caen
country: France
facility: Centre F.Baclesse
city: Caen
country: France
facility: CHU Caen
city: Clamart
country: France
facility: Hôpital d'instruction des armées Percy
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Colmar
country: France
facility: CH Colmar
city: Dijon
country: France
facility: CH Dijon
city: Dunkerque
country: France
facility: CHG Dunkerque
city: Grenoble
country: France
facility: CH Grenoble
city: La Roche sur yon
country: France
facility: CH La Roche sur yon
city: Laval
country: France
facility: CH Laval
city: Le Mans
country: France
facility: Le Mans Victor Hugo
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Saint Brieuc
country: France
facility: Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie
city: Toulouse
country: France
facility: CHU Toulouse Purpan
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Vandoeuvre
country: France
facility: Service d'Hématologie - Hôpital de Brabois
Study officials:
affiliation: Rennes University Hospital
name: Olivier DECAUX, MD
role: PRINCIPAL_INVESTIGATOR
References: