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

Not Applicable

Completed

• Conditions: Multiple Myeloma

• 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

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)

CHU Amiens; 🇫🇷 Amiens, France

CH Beauvais; 🇫🇷 Beauvais, France

Ch Saint Quentin; 🇫🇷 Saint Quentin, France