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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 8, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE February 23, 2009
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Serum Macrophage-Colony Stimulating Factor (M-CSF) levels [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Tumour osteolysis [ Time Frame: Day 1 ]
determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
Official Title  ICMJE Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Biological: blood samples
  • Biological: Bone marow samples
Study Arms  ICMJE
  • Experimental: multiple myeloma group
    case group = patients with multiple myeloma
    Interventions:
    • Biological: blood samples
    • Biological: Bone marow samples
  • Experimental: MGUS group
    monoclonal gammopathy of undetermined significance
    Interventions:
    • Biological: blood samples
    • Biological: Bone marow samples
  • healthy control group
    control group = healthy subjects
    Intervention: Biological: blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2019)
111
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
200
Actual Study Completion Date  ICMJE July 10, 2018
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800954
Other Study ID Numbers  ICMJE AOL08-DR-SALLE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valéry SALLE, PhD CHU Amiens
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP