Multiple MyelomaMCSF-MYELOMENCT02800954
Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
A study testing blood samples and Bone marow samples in people with Multiple Myeloma, run by Centre Hospitalier Universitaire, Amiens at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- blood samples and Bone marow samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Feb 2009to 10 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
CHU Amiens
Amiens, 80054
CH Beauvais
Beauvais, 60021
Ch Saint Quentin
Saint-Quentin, 02321
About this study
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.
- Conditions
- Multiple Myeloma
- Being tested
- blood samples, Bone marow samples
- Keywords
- Multiple Myeloma, bone lesions, Macrophage-Colony Stimulating Factor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
Bone marow samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| multiple myeloma group | Experimental | case group = patients with multiple myeloma Receives: Biological: blood samples; Biological: Bone marow samples |
| MGUS group | Experimental | monoclonal gammopathy of undetermined significance Receives: Biological: blood samples; Biological: Bone marow samples |
| healthy control group | Other | control group = healthy subjects Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Macrophage-Colony Stimulating Factor (M-CSF) levels
Measured: Day 1
Secondary outcomes (1)
Tumour osteolysis
determined by the presence of osteolytic lesions, osteopenia or pathological fractures, presence of bone pain
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start23 Feb 2009
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valéry SALLE, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800954
- Sponsor's protocol ID
- AOL08-DR-SALLE
- Acronym
- MCSF-MYELOME
- Status last verified
- Nov 2025
- First submitted
- 8 Jun 2016
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29786478
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02800954
- Acronym / sponsor ID
- MCSF-MYELOME / AOL08-DR-SALLE
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, bone lesions, Macrophage-Colony Stimulating Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 23 Feb 2009 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multiple myeloma group | Experimental | Biological: blood samples, Biological: Bone marow samplescase group = patients with multiple myeloma |
| MGUS group | Experimental | Biological: blood samples, Biological: Bone marow samplesmonoclonal gammopathy of undetermined significance |
| healthy control group | Other | Biological: blood samplescontrol group = healthy subjects |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples | Biological | MGUS group, healthy control group, multiple myeloma group |
| Bone marow samples | Biological | MGUS group, multiple myeloma group |
Primary outcome
Serum Macrophage-Colony Stimulating Factor (M-CSF) levels
Time frame: Day 1
1 secondary outcome
Tumour osteolysis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 29786478From 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valéry SALLE, PhD principal investigator
CHU Amiens
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples and Bone marow samples in people with Multiple Myeloma, run by Centre Hospitalier Universitaire, Amiens at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Macrophage-Colony Stimulating Factor (M-CSF) levels (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.