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Myeloma MultiplePhase 3MYELOCHOLNCT03891914

Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma

A Phase 3 study testing Positron Emission Tomography using 18F-FCH and Positron Emission Tomography using 18F-FDG in people with Myeloma Multiple, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloma Multiple
What is being tested?
Positron Emission Tomography using 18F-FCH and Positron Emission Tomography using 18F-FDG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
12 Nov 2019to 31 Jan 2023
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic Multiple Myeloma on first-line treatment as defined by 2014 International Myeloma Working Group criteria
  • Measurable disease either by serum or urinary monoclonal protein level or by serum free light chains assay
  • Age > 18 years old at time of signed consent
  • Beneficiary of social security insurance
  • Signed informed consent

Who cannot join

  • Previous Multiple Myeloma treatment
  • Previous cancer with less than 5 year of complete remission (including plasmacytoma)
  • Chemotherapy in the 6 months preceding the inclusion
  • Uncontrolled diabetes mellitus
  • Medullary growth factor injection less than 48 hours before imaging procedures
  • Ongoing corticosteroid therapy, or given less than 72 hours before PET-CT imaging
Show all 12Show fewer
  • Pregnant or nursing (lactating) women
  • Childbearing potential woman without adequate barrier contraception method (HAS criteria)
  • Freedom deprivated patient by judiciary or administrative decision
  • Patient under legal protection or unable to express its own consent
  • PET contraindication (known allergy to 18F-FCH or 18F-FDG or excipient)
  • MRI contraindication

Trial locations and contacts

1 site in 1 country.

France1 site

  • Bordeaux University Hospital - Haut-Lévêque

    Pessac, 33604

Other trials in France

About this study

Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the International Myeloma Working Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diagnosis, and could bring better baseline information than FDG PET for therapy evaluation. Ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18F-FDG in a recent retrospective study, with about 70% more lesions detected in MM patients with suspected relapsing disease. Following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our secondary objectives will be to compare the performance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.

Being tested
Positron Emission Tomography using 18F-FCH, Positron Emission Tomography using 18F-FDG
Keywords
Multiple Myeloma, PET/CT, 18F-FDG, 18F-FCH
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positron Emission Tomography using 18F-FCHDrug

    Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FCH(or fluorocholine) for the detection of bone lesions

  • Positron Emission Tomography using 18F-FDGDrug

    Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FDG (or fluorodeoxyglucose) for the detection of bone lesions

Study groups in NCT03891914
Study groupRoleWhat they receive
Symptomatic Multiple Myeloma on first-line treatmentExperimentalNot described
Receives: Drug: Positron Emission Tomography using 18F-FCH; Drug: Positron Emission Tomography using 18F-FDG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of whole-body bone lesions

    The numbers of bone lesions detected by 18F-FCH PET-CT and that are suspected to be related to multiple myeloma, will be counted. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus.

    Measured: Day 0

  2. Number of whole-body bone lesions

    The numbers of bone lesions detected by 18F-FDG PET-CT, and that are suspected to be related to multiple myeloma, will be counted. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus.

    Measured: Day 7

  3. Number of bone lesions within defined skeletal areas

    Six skeletal areas are defined : skull - spine - pelvis - sternum and ribs - superior limbs - inferior limbs. The number of bone lesions that are suspected to be related to myeloma in each of these skeletal area is assessed on 18F-FCH PET-CT Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus

    Measured: Day 0

  4. Number of bone lesions within defined skeletal areas

    Six skeletal areas are defined : skull - spine - pelvis - sternum and ribs - superior limbs - inferior limbs. The number of bone lesions that are suspected to be related to myeloma in each of these skeletal area is assessed on 18F-FDG PET-CT. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus

    Measured: Day 7

Secondary outcomes (6)

  1. Diagnostic performance for the detection of focal bone lesions

    Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FCH PET-CT will be calculated based on two different reference test. First reference test will be standard MRI sequences (T1SE, T2-STIR). Second reference test will be composed of standard MRI sequences plus whole-body diffusion MRI acquisitions.

    Measured: Day 0

  2. Diagnostic performance for the detection of focal bone lesions

    Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FDG PET-CT will be calculated based on two different reference test. First reference test will be standard MRI sequences (T1SE, T2-STIR). Second reference test will be composed of standard MRI sequences plus whole-body diffusion MRI acquisitions.

    Measured: Day 7

  3. Diagnostic performances for the detection of diffuse infiltrative disease of the spine

    Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FDG PET-CT will be calculated based on standard MRI sagittal acquisitions of the spine.

    Measured: Day 7

  4. Diagnostic performances for the detection of diffuse infiltrative disease of the spine

    Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FCH PET-CT will be calculated based on standard MRI sagittal acquisitions of the spine.

    Measured: Day 0

  5. Number of extra-medullary lesions

    Each extra-medullary lesion detected on 18F-FDG PET-CT will be validated by an expert multidisciplinary consensus

    Measured: Day 7

  6. Number of extra-medullary lesions

    Each extra-medullary lesion detected on 18F-FCH PET-CT will be validated by an expert multidisciplinary consensus

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start12 Nov 2019
  3. Primary completion27 Jan 2023
  4. Study completion31 Jan 2023

Resources

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03891914
Sponsor's protocol ID
CHUBX 2017/32
Other IDs
2018-003926-10, 2018
Acronym
MYELOCHOL
Status last verified
Jul 2025
First submitted
25 Mar 2019
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mesguich C, Hulin C, Latrabe V, Asselineau J, Bordenave L, Perez P, Hindie E, Marit G. Prospective Comparison of 18F-Choline Positron Emission Tomography/Computed Tomography (PET/CT) and 18F-Fluorodeoxyglucose (FDG) PET/CT in the Initial Workup of Multiple Myeloma: Study Protocol of a Prospective Imaging Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e17850. doi: 10.2196/17850.

    PubMed 32909953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Positron Emission Tomography using 18F-FCH and Positron Emission Tomography using 18F-FDG in people with Myeloma Multiple, run by University Hospital, Bordeaux at 1 site 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 5 inclusion and 12 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Number of whole-body bone lesions (time frame: Day 0). The study lists 4 primary outcomes in all. 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 NCT03891914, 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 12 May 2026.

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