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

Monoclonal Gammopathy of Undetermined Significance Clinical Trial

— GENOMGUS  

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079429
• Other study ID #: RCB 2008-A01023-52
• Secondary ID: AFSSAPS B80894-6
• Status: Terminated
• Start date: January 12, 2009
• Est. completion date: September 2019

Study information

• Verified date: April 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1200
• Est. completion date: September 2019
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Smoldering Multiple Myeloma
• Smoldering Myeloma

Intervention

Genetic:
• Genetic study of DNA copies
Gene expression profiling, DNA copy number variation

Locations

Country	Name	City	State
France	CHU Amiens - médecine interne	Amiens
France	CHU Angers	Angers
France	Centre Hospitalier H.Duffaut - Avignon	Avignon
France	Hôpital Jean Minjoz - Besancon	Besancon
France	Service de Médecine interne - Centre Hospitalier	Blois
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	Dunkerque
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	Nantes University Hospital	Nantes	Pays De Loire
France	Rennes University Hospital	Rennes	Bretagne
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	Vandoeuvre

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Intergroupe Francophone du Myelome

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression to symptomatic multiple myeloma		Every 6 or 12 months during 5 years