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

Multiple Myeloma Clinical Trial

— MCSF-MYELOME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800954
• Other study ID #: AOL08-DR-SALLE
• Status: Completed
• Phase: N/A
• Start date: February 23, 2009
• Est. completion date: July 10, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• blood samples

• Bone marow samples

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CH Beauvais	Beauvais
France	Ch Saint Quentin	Saint Quentin

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Macrophage-Colony Stimulating Factor (M-CSF) levels		Day 1
Secondary	Tumour osteolysis	determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain	Day 1