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

Study Overview
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Brief Summary
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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.

Official Title
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Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Biological: blood samples
* Biological: Bone marow samples


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multiple myeloma group<br>case group = patients with multiple myeloma | Biological: blood samples<br> <br> Biological: Bone marow samples<br> <br> |
| Experimental: MGUS group<br>monoclonal gammopathy of undetermined significance | Biological: blood samples<br> <br> Biological: Bone marow samples<br> <br> |
| Other: healthy control group<br>control group = healthy subjects | Biological: blood samples<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Macrophage-Colony Stimulating Factor (M-CSF) levels |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour osteolysis | determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, bone lesions, Macrophage-Colony Stimulating Factor