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

C

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Multiple Myeloma

Treatments

Biological: blood samples
Biological: Bone marow samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02800954
AOL08-DR-SALLE

Details and patient eligibility

About

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.

Enrollment

111 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

111 participants in 3 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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