Multiple MyelomaPhase 3IMAJEMNCT01309334
Imaging Young Myeloma (IMAgerie JEune Myélome)
A Phase 3 study testing PET scan and MRI in people with Multiple Myeloma, run by Nantes University Hospital at 17 sites in France.
Trial summary
Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- PET scan and MRI
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 17 sitesFrance
- Study dates
- Feb 2011to Sep 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic de novo multiple myeloma
- less than 65 years of age
- enrolled in the IFM/DFCI clinical trial
Who cannot join
- 66 years of age or more
- not eligible for high-dose therapy
- Cons-indications to MRI or PET-Scan
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Bordeaux University Hospital
Bordeaux
Brest University Hospital "CHU du Morvan"
Brest
Hospital "Côte de Nacre"
Caen
Clermont-Ferrand University Hospital
Clermont-Ferrand
Dijon University Hospital
Dijon
Grenoble University Hospital "Hôpital Michallon"
Grenoble
Le Mans Hospital
Le Mans
Lille University Hospital "Claude Huriez"
Lille
Lyon University Hospital
Lyon
"Institut Paoli Calmettes"
Marseille
Metz University Hospital "Hôpital de Mercy"
Metz
Nancy University Hospita "Hôpitaux de Brabois"
Nancy
Nantes University Hospital
Nantes, 44000
APHP "Hôpital Saint-Antoine"
Paris
Rennes University Hospital
Rennes
Toulouse University Hospital
Toulouse
Tours University Hospital "Hôpital Bretonneau"
Tours
About this study
Official title: Pharmacoeconomic and Clinical Prospective Comparison of PET-scan and MRI in Patients With de Novo Multiple Myeloma Less Than 65 Years of Age Treated According to IFM/DFCI 2009 Clinical Trial.
Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.
- Conditions
- Multiple Myeloma
- Being tested
- PET scan, MRI
- Keywords
- MRI, PET-scan, multiple myeloma, prognosis, pharmacoeconomic analysis
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanProcedure or surgery
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
MRIProcedure or surgery
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with at least one lesion not detected on the MRI lesions
Measured: At diagnosis
Secondary outcomes (4)
Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment
Measured: 3 months and 7 months
Number of lesions at diagnosis
Measured: Inclusion (diagnosis)
diffuse disease at diagnosis
Measured: Diagnosis time (inclusion)
Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment
Measured: Inclusion, 3 months and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Nantes University HospitalThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309334
- Sponsor's protocol ID
- STIC/10/03
- Other IDs
- 2010-A01382-37
- Acronym
- IMAJEM
- Status last verified
- Aug 2014
- First submitted
- 4 Mar 2011
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Moreau P, Attal M, Caillot D, Macro M, Karlin L, Garderet L, Facon T, Benboubker L, Escoffre-Barbe M, Stoppa AM, Laribi K, Hulin C, Perrot A, Marit G, Eveillard JR, Caillon F, Bodet-Milin C, Pegourie B, Dorvaux V, Chaleteix C, Anderson K, Richardson P, Munshi NC, Avet-Loiseau H, Gaultier A, Nguyen JM, Dupas B, Frampas E, Kraeber-Bodere F. Prospective Evaluation of Magnetic Resonance Imaging and [18F]Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography at Diagnosis and Before Maintenance Therapy in Symptomatic Patients With Multiple Myeloma Included in the IFM/DFCI 2009 Trial: Results of the IMAJEM Study. J Clin Oncol. 2017 Sep 1;35(25):2911-2918. doi: 10.1200/JCO.2017.72.2975. Epub 2017 Jul 7.
PubMed 28686535Zamagni E, Nanni C, Dozza L, Carlier T, Bailly C, Tacchetti P, Versari A, Chauvie S, Gallamini A, Gamberi B, Caillot D, Patriarca F, Macro M, Boccadoro M, Garderet L, Barbato S, Fanti S, Perrot A, Gay F, Sonneveld P, Karlin L, Cavo M, Bodet-Milin C, Moreau P, Kraeber-Bodere F. Standardization of 18F-FDG-PET/CT According to Deauville Criteria for Metabolic Complete Response Definition in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Jan 10;39(2):116-125. doi: 10.1200/JCO.20.00386. Epub 2020 Nov 5.
PubMed 33151787Jamet B, Morvan L, Nanni C, Michaud AV, Bailly C, Chauvie S, Moreau P, Touzeau C, Zamagni E, Bodet-Milin C, Kraeber-Bodere F, Mateus D, Carlier T. Random survival forest to predict transplant-eligible newly diagnosed multiple myeloma outcome including FDG-PET radiomics: a combined analysis of two independent prospective European trials. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1005-1015. doi: 10.1007/s00259-020-05049-6. Epub 2020 Oct 2.
PubMed 33006656
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacoeconomic and Clinical Prospective Comparison of PET-scan and MRI in Patients With de Novo Multiple Myeloma Less Than 65 Years of Age Treated According to IFM/DFCI 2009 Clinical Trial.
- ClinicalTrials.gov ID
- NCT01309334
- Acronym / sponsor ID
- IMAJEM / STIC/10/03
- Conditions
- Multiple Myeloma
- Keywords
- MRI, PET-scan, multiple myeloma, prognosis, pharmacoeconomic analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Feb 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Mar 2011 (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.
Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic de novo multiple myeloma
- less than 65 years of age
- enrolled in the IFM/DFCI clinical trial
Key exclusion criteria (3 listed)
- 66 years of age or more
- not eligible for high-dose therapy
- Cons-indications to MRI or PET-Scan
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 |
|---|---|---|
| PET scanPerformed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy | Procedure or surgery | – |
| MRIPerformed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy | Procedure or surgery | – |
Primary outcome
Number of patients with at least one lesion not detected on the MRI lesions
Time frame: At diagnosis
4 secondary outcomes
Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment
Time frame: 3 months and 7 months
Number of lesions at diagnosis
Time frame: Inclusion (diagnosis)
diffuse disease at diagnosis
Time frame: Diagnosis time (inclusion)
Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment
Time frame: Inclusion, 3 months and 7 months
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 14 Sep 2026.
- Results publication: PubMed 28686535Moreau P, Attal M, Caillot D, Macro M, Karlin L, Garderet L, Facon T, Benboubker L, Escoffre-Barbe M, Stoppa AM, Laribi K, Hulin C, Perrot A, Marit G, Eveillard JR, Caillon F, Bodet-Milin C, Pegourie B, Dorvaux V, Chaleteix C, Anderson K, Richardson P, Munshi NC, Avet-Loiseau H, Gaultier A, Nguyen JM, Dupas B, Frampas E, Kraeber-Bodere F. Prospective Evaluation of Magnetic Resonance Imaging and [18F]Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography at Diagnosis and Before Maintenance Therapy in Symptomatic Patients With Multiple Myeloma Included in the IFM/DFCI 2009 Trial: Results of the IMAJEM Study. J Clin Oncol. 2017 Sep 1;35(25):2911-2918. doi: 10.1200/JCO.2017.72.2975. Epub 2017 Jul 7.
- Derived from this study: PubMed 33151787Zamagni E, Nanni C, Dozza L, Carlier T, Bailly C, Tacchetti P, Versari A, Chauvie S, Gallamini A, Gamberi B, Caillot D, Patriarca F, Macro M, Boccadoro M, Garderet L, Barbato S, Fanti S, Perrot A, Gay F, Sonneveld P, Karlin L, Cavo M, Bodet-Milin C, Moreau P, Kraeber-Bodere F. Standardization of 18F-FDG-PET/CT According to Deauville Criteria for Metabolic Complete Response Definition in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Jan 10;39(2):116-125. doi: 10.1200/JCO.20.00386. Epub 2020 Nov 5.
- Derived from this study: PubMed 33006656Jamet B, Morvan L, Nanni C, Michaud AV, Bailly C, Chauvie S, Moreau P, Touzeau C, Zamagni E, Bodet-Milin C, Kraeber-Bodere F, Mateus D, Carlier T. Random survival forest to predict transplant-eligible newly diagnosed multiple myeloma outcome including FDG-PET radiomics: a combined analysis of two independent prospective European trials. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1005-1015. doi: 10.1007/s00259-020-05049-6. Epub 2020 Oct 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET scan and MRI in people with Multiple Myeloma, run by Nantes University Hospital at 17 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 3 inclusion and 3 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
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 patients with at least one lesion not detected on the MRI lesions (time frame: At diagnosis). 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 NCT01309334, which also lists 3 linked publications.
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 14 Sep 2026.