Study Stopped
sponsor and investigator 's decision
Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From MGUS and SMM.
GENOMGUS
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).
3 other identifiers
observational
1,200
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2009
CompletedFirst Submitted
Initial submission to the registry
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedApril 15, 2021
April 1, 2021
5 years
March 1, 2010
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression to symptomatic multiple myeloma
Every 6 or 12 months during 5 years
Study Arms (1)
MGUS or SMM
Patients with Monoclonal gammopathy of undetermined significance or smoldering myeloma
Interventions
Eligibility Criteria
Patients with Monoclonal gammopathy of undetermined significance or Smoldering myeloma
You may qualify if:
- 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
- +14 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rennes University Hospitallead
- Intergroupe Francophone du Myelomecollaborator
Study Sites (27)
Rennes University Hospital
Rennes, Brittany Region, 35000, France
Nantes University Hospital
Nantes, Pays de Loire, 44000, France
CHU Amiens - médecine interne
Amiens, France
CHU Angers
Angers, France
Centre Hospitalier H.Duffaut - Avignon
Avignon, France
Hôpital Jean Minjoz - Besancon
Besançon, France
Service de Médecine interne - Centre Hospitalier
Blois, 41016, France
Bordeaux Bergonié
Bordeaux, France
Bordeaux Haut Leveque
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Hôpital A.Morvan Brest
Brest, France
Centre F.Baclesse
Caen, France
CHU Caen
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
Dunkirk, 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
Vandœuvre-lès-Nancy, 54511, France
Biospecimen
Whole blood Plasma Urine Bone marrow
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier DECAUX, MD
Rennes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2010
First Posted
March 3, 2010
Study Start
January 12, 2009
Primary Completion
January 1, 2014
Study Completion
September 1, 2019
Last Updated
April 15, 2021
Record last verified: 2021-04