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

Rennes University Hospital

Status: Terminated

Conditions: Smoldering Myeloma; Monoclonal Gammopathy of Undetermined Significance

Treatments: Genetic: Genetic study of DNA copies

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT01079429

RCB 2008-A01023-52

IFM 08-02 (Other Identifier)

AFSSAPS B80894-60 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

MGUS or SMM

Description:

Patients with Monoclonal gammopathy of undetermined significance or smoldering myeloma

Treatment:

Genetic: Genetic study of DNA copies