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

January 21, 2019 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Beauvais, France, 60021
        • CH Beauvais
      • Saint Quentin, France, 02321
        • CH Saint Quentin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Valéry SALLE, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2009

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

July 10, 2018

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOL08-DR-SALLE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe