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

Not Applicable

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: blood samples; Biological: Bone marow samples

• Registration Number: NCT02800954
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-23
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multiple myeloma group	blood samples	case group = patients with multiple myeloma
healthy control group	blood samples	control group = healthy subjects
multiple myeloma group	Bone marow samples	case group = patients with multiple myeloma
MGUS group	blood samples	monoclonal gammopathy of undetermined significance
MGUS group	Bone marow samples	monoclonal gammopathy of undetermined significance

Primary Outcome Measures

Name	Time	Method
Serum Macrophage-Colony Stimulating Factor (M-CSF) levels	Day 1

Secondary Outcome Measures

Name	Time	Method
Tumour osteolysis	Day 1	determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain

Trial Locations

Locations (3)

Ch Saint Quentin; 🇫🇷 Saint Quentin, France

CH Beauvais; 🇫🇷 Beauvais, France

CHU Amiens; 🇫🇷 Amiens, France