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

NCT ID: NCT02800954

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-23

Study Completion Date

2018-07-10

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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multiple myeloma group

case group = patients with multiple myeloma

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

Bone marow samples

Intervention Type BIOLOGICAL

MGUS group

monoclonal gammopathy of undetermined significance

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

Bone marow samples

Intervention Type BIOLOGICAL

healthy control group

control group = healthy subjects

Group Type OTHER

blood samples

Intervention Type BIOLOGICAL

Interventions

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blood samples

Intervention Type BIOLOGICAL

Bone marow samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valéry SALLE, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

CH Beauvais

Beauvais, , France

Site Status

Ch Saint Quentin

Saint-Quentin, , France

Site Status

Countries

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France

References

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From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.

Reference Type RESULT
PMID: 29786478 (View on PubMed)

Other Identifiers

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AOL08-DR-SALLE

Identifier Type: -

Identifier Source: org_study_id

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