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Completed

NCT Number: NCT02800954

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood samples

Biological

Bone marow samples

Biological

Primary outcomes

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

    Time frame: Day 1

Secondary outcomes

  1. Tumour osteolysis

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: MCSF-MYELOME

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2016
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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