Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma (MCSF-MYELOME)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Multiple Myeloma

Treatments: Biological: blood samples; Biological: Bone marow samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02800954

AOL08-DR-SALLE

Details and patient eligibility

About

The Primary objective of this study is to compare serum levels of Macrophage-Colony Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in a control population.

Enrollment: 111 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For the multiple myeloma group

• confirmed diagnosis of de novo multiple myeloma according to the International Myeloma Working Group criteria
• bisphosphonate therapy for more than 60 days,
• signature of the informed consent form,
• patients over the age of 18 years. For the monoclonal gammopathy of undetermined significance (MGUS) group
• confirmed diagnosis of MGUS according to the International Myeloma Working Group criteria
• signature of the informed consent form,
• patients over the age of 18 years. For the healthy control group
• signature of the informed consent form,
• subjects over the age of 18 years.

Exclusion criteria

• patients with thyroid or parathyroid disease,
• osteomalacia, rheumatoid arthritis, Paget's disease, osteoporosis,
• bisphosphonate therapy for less than 60 days,
• absence of informed consent,
• patients under the age of 18 years.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

multiple myeloma group

Experimental group

Description:

case group = patients with multiple myeloma

Treatment:

Biological: blood samples

Biological: Bone marow samples

MGUS group

Experimental group

Description:

monoclonal gammopathy of undetermined significance

Treatment:

Biological: blood samples

Biological: Bone marow samples

healthy control group

Other group

Description:

control group = healthy subjects

Treatment:

Biological: blood samples