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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Bone marow samples
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring Multiple Myeloma, bone lesions, Macrophage-Colony Stimulating Factor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU Amiens
  • CH Beauvais
  • Ch Saint Quentin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

multiple myeloma group

MGUS group

healthy control group

Arm Description

case group = patients with multiple myeloma

monoclonal gammopathy of undetermined significance

control group = healthy subjects

Outcomes

Primary Outcome Measures

Serum Macrophage-Colony Stimulating Factor (M-CSF) levels

Secondary Outcome Measures

Tumour osteolysis
determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain

Full Information

First Posted
June 8, 2016
Last Updated
January 21, 2019
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02800954
Brief Title
Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
Acronym
MCSF-MYELOME
Official Title
Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 23, 2009 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, bone lesions, Macrophage-Colony Stimulating Factor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
multiple myeloma group
Arm Type
Experimental
Arm Description
case group = patients with multiple myeloma
Arm Title
MGUS group
Arm Type
Experimental
Arm Description
monoclonal gammopathy of undetermined significance
Arm Title
healthy control group
Arm Type
Other
Arm Description
control group = healthy subjects
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Type
Biological
Intervention Name(s)
Bone marow samples
Primary Outcome Measure Information:
Title
Serum Macrophage-Colony Stimulating Factor (M-CSF) levels
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Tumour osteolysis
Description
determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valéry SALLE, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CH Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Ch Saint Quentin
City
Saint Quentin
ZIP/Postal Code
02321
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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