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

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ClinicalTrials.gov Identifier: NCT02800954
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: blood samples Biological: Bone marow samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
Actual Study Start Date : February 23, 2009
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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
healthy control group
control group = healthy subjects
Biological: blood samples



Primary Outcome Measures :
  1. Serum Macrophage-Colony Stimulating Factor (M-CSF) levels [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Tumour osteolysis [ Time Frame: Day 1 ]
    determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800954


Locations
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France
CHU Amiens
Amiens, France, 80054
CH Beauvais
Beauvais, France, 60021
Ch Saint Quentin
Saint Quentin, France, 02321
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Valéry SALLE, PhD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02800954    
Other Study ID Numbers: AOL08-DR-SALLE
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Multiple Myeloma
bone lesions
Macrophage-Colony Stimulating Factor
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases