NCT02800954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P75+ for not_applicable multiple-myeloma

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable multiple-myeloma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2009

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

9.4 years

First QC Date

June 8, 2016

Last Update Submit

November 17, 2025

Conditions

Multiple Myeloma

Keywords

Multiple Myelomabone lesionsMacrophage-Colony Stimulating Factor

Outcome Measures

Primary Outcomes (1)

  • Serum Macrophage-Colony Stimulating Factor (M-CSF) levels

    Day 1

Secondary Outcomes (1)

  • Tumour osteolysis

    Day 1

Study Arms (3)

multiple myeloma group

EXPERIMENTAL

case group = patients with multiple myeloma

Biological: blood samplesBiological: Bone marow samples

MGUS group

EXPERIMENTAL

monoclonal gammopathy of undetermined significance

Biological: blood samplesBiological: Bone marow samples

healthy control group

OTHER

control group = healthy subjects

Biological: blood samples

Interventions

blood samplesBIOLOGICAL
MGUS grouphealthy control groupmultiple myeloma group
Bone marow samplesBIOLOGICAL
MGUS groupmultiple myeloma group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Amiens

Amiens, 80054, France

Location

CH Beauvais

Beauvais, 60021, France

Location

Ch Saint Quentin

Saint-Quentin, 02321, France

Location

Related Publications (1)

  • 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.

    PMID: 29786478RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Valéry SALLE, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 15, 2016

Study Start

February 23, 2009

Primary Completion

July 10, 2018

Study Completion

July 10, 2018

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

FR(3)