MyelomaMYMONCT03618212
MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?
An observational study of Myeloma, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- MRI
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Dec 2018to 31 Mar 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with myeloma as diagnosed according to the International Myeloma Working Group criteria recruited in the service of clinical hematology in either the CHUs of Nîmes or Montpellier
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old
- Patient has been diagnosed with multiple myeloma (> 10% medullary plasma cells + monoclonal protein) or symptomatic myeloma (myeloma + CRAB symptoms (hypercalcemia, renal failure, anemia, bone lesions), or indolent myeloma (myeloma with symptomatic criteria).
Who cannot join
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breast feeding
- The patient has an absolute contra-indication for MRI (pace-maker, claustrophobic patient, metal heart valve)
Trial locations and contacts
2 sites in 1 country.
About this study
The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.
- Conditions
- Myeloma
- Being tested
- MRI
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Skeletal MRI and pelvic and spinal MRI
| Study group | Role | What they receive |
|---|---|---|
| Myeloma patients | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Fatty tissue replacement by tumoral tissue observed by hyposignal T1 and hypersignal T2 FS or short-TI Inversion Recovery ≥ 5mm
Measured: Day 0
Secondary outcomes (7)
Number of "punched out" lesions ≥ 5mm identified by whole-body MRI with diffusion sequences versus skeletal X-ray
Measured: Day 0
Agreement between identification of normal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Measured: Day 0
Agreement between identification of diffuse lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Measured: Day 0
Agreement between identification of mixed lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Measured: Day 0
Agreement between identification of salt and pepper lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Measured: Day 0
Link between type of infiltration and spinal cord karyotype
Yes/no presence of anomaly, and if yes, type of karyotype anomaly
Measured: Day 0
Inter-observer reproducibility for the first 20 patients for the detection of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start21 Dec 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Departure of the project leader
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Larbi, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618212
- Sponsor's protocol ID
- AOIGCSMERRIL/2016/AL-01
- Acronym
- MYMO
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2018
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?
- ClinicalTrials.gov ID
- NCT03618212
- Acronym / sponsor ID
- MYMO / AOIGCSMERRIL/2016/AL-01
- Conditions
- Myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Departure of the project leader
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 Aug 2018 (actual)
- 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 investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myeloma patients | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with myeloma as diagnosed according to the International Myeloma Working Group criteria recruited in the service of clinical hematology in either the CHUs of Nîmes or Montpellier
Key inclusion criteria (4 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old
- Patient has been diagnosed with multiple myeloma (> 10% medullary plasma cells + monoclonal protein) or symptomatic myeloma (myeloma + CRAB symptoms (hypercalcemia, renal failure, anemia, bone lesions), or indolent myeloma (myeloma with symptomatic criteria).
Key exclusion criteria (5 listed)
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breast feeding
- The patient has an absolute contra-indication for MRI (pace-maker, claustrophobic patient, metal heart valve)
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 |
|---|---|---|
| MRISkeletal MRI and pelvic and spinal MRI | Diagnostic test | Myeloma patients |
Primary outcome
Identification of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Time frame: Day 0
Fatty tissue replacement by tumoral tissue observed by hyposignal T1 and hypersignal T2 FS or short-TI Inversion Recovery ≥ 5mm
7 secondary outcomes
Number of "punched out" lesions ≥ 5mm identified by whole-body MRI with diffusion sequences versus skeletal X-ray
Time frame: Day 0
Agreement between identification of normal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Time frame: Day 0
Agreement between identification of diffuse lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Time frame: Day 0
Agreement between identification of mixed lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Time frame: Day 0
Agreement between identification of salt and pepper lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences
Time frame: Day 0
Link between type of infiltration and spinal cord karyotype
Time frame: Day 0
Inter-observer reproducibility for the first 20 patients for the detection of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Departure of the project leader). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
Related trials for Myeloma
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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.
Ahmed Larbi, MD principal investigator
CHU Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma, run by Centre Hospitalier Universitaire de Nīmes at 2 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 4 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: stopped early, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Departure of the project leader). Results are not available in the source record.
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?
Identification of focal lesions ≥ 5mm by axial skeletal MRI of spine and pelvis versus whole-body MRI using diffusion sequences (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2021.