Multiple MyelomaNCT04609150
Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)
An observational study of Multiple Myeloma and Vertebral Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Vertebral Fracture
- What is being tested?
- Bone marrow fat quantification by MRI
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2020to Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group, with vertebral fractures treated by vertebroplasty from January 2017 to December 2021, with recent clinical and biological data available at the time of imaging and fracture events.
Who may be able to join
- Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group
- vertebral fractures treated by vertebroplasty from January 2017 to December 2021
- recent clinical and biological data available at the time of imaging and fracture events
Who cannot join
- Factors modifying the bone marrow fat fraction (extensive radiotherapy)
- Lack of recent clinical or biological data compared to imaging examinations
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AP-HP, Lariboisière Hospital, Osteo-Articular, Visceral and Vascular Imaging department
Paris, 75010
Gregoire ATTANE, MD, +33 (0)688595952, gregoire_attane@hotmail.com
About this study
Official title: Assessment of Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Patients With Multiple Myeloma
Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. The main objective is to assess the correlation between vertebral bone marrow fat fraction and bone fragility represented by a severity score of vertebral fractures. The secondary objective is to assess the correlation with clinical and biological prognostic factors and scores..
Read the detailed description
Patients treated with vertebroplasty will be included during the period of the study, retrospectively or prospectively.
Mains collected data are represented by :
- Bone marrow fat fraction determined by MRI
- Severity score for vertebral fractures
- Clinical prognostic factors
- Biological prognostic factors
- Clinico-biological scores Descriptive statistics and correlation analyses will be performed between the measured parameters.
- Conditions
- Multiple Myeloma, Vertebral Fracture
- Being tested
- Bone marrow fat quantification by MRI
- Keywords
- Bone marrow fat, Bone fragility, Fat quantification
- Medical subject headings
- Multiple Myeloma, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow fat quantification by MRIOther
Bone marrow fat quantification by MRI at the moment of the diagnosis of vertebral fracture before treatment by vertebroplasty
| Study group | Role | What they receive |
|---|---|---|
| Multiple myeloma patients with vertebral fractures | Patients followed for multiple myeloma in the Lariboisière/Saint-Louis/Fernand-Widal hospital group, with vertebral fractures treated by vertebroplasty from January 2017 to December 2021, with recent clinical and biological data available at the time of imaging and fracture events Receives: Other: Bone marrow fat quantification by MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of bone marrow fat in vertebral bone marrow
Measured from Dixon sequences on MRI exams performed in routine care, for the assessment of the relationship between bone marrow vertebral fat content and the severity of the vertebral fractures
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Vertebral fracture severity score
Score established according to morphological criteria determined by MRI/computerized tomography scan, based on the Genant classification. Calculation of sum of the points awarded as follows: vertebral fracture on osteolytic lesion = 3; osteolytic lesion with high fracture risk = 0; other fracture related to increased bone fragility, scale 1-3 according to Genant's criteria, 3 representing the worst situation; normal vertebra = 0.
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Secondary outcomes (17)
Sex
Male or female
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Age at the diagnosis of multiple myeloma
Age in years at the diagnosis of multiple myeloma
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Weight/body mass index (BMI)
The Body Mass Index is calculated as the ratio between the weight measured in kilograms and the square of the height measured in meters
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Age at the moment of the vertebral fracture
Age in years at the moment of the vertebral fracture
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Type of the monoclonal component
Corresponding the type of the heavy (IgG, IgA, IgD, IgE or IgM) and/or the light chain (κ or λ) of the monoclonal immunoglobulin protein
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Serum rate of the monoclonal component
Serum rate of the monoclonal immunoglobulin protein in g/L
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Medullary plasmacytosis
Percentage of plasma cells assessed by bone marrow aspiration
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of anaemia
Defined by hemoglobin value < 100g/L
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of hypercalcemia
Defined by serum calcium > 2.75mmol/L
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of renal failure related to myeloma
Defined by a creatinine clearance < 40mL/min or serum creatinine > 177µmol/L
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of amyloidosis
Presence of amyloid deposits revealed by tissue biopsy
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Multiple myeloma stage according to the Salmon-Durie staging System
The Salmon-Durie classification in three stages according to the absence (I) or the presence (III) of the following criteria: anemia (hemoglobin value < 100g/L); hypercalcemia (serum calcium > 2.75mmol/L); amyloidosis (amyloid deposits revealed by biopsy); bone lesion at imaging. Concerning the serum rate of the monoclonal component, IgA < 30g/L and IgG < 50 g/L are considered stage I, and IgA > 50g/L and IgG > 70 g/L are considered stage III. The intermediate stage II is based on the rate of the blood monoclonal component (from 30 to 50 g/L for IgA and from 50 to 70 g/L for IgG) . The subclassification depends on the absence (A) or the presence of renal failure related to myeloma (B) (defined by creatinine clearance < 40mL/min or serum creatinine > 177µmol/L).
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Multiple myeloma stage according to the International Staging System (ISS)
To determine the International Staging System score (ISS) in three stages with stage I corresponding to serum beta-2-microglobulin < 3.5 mg/L and serum albumin ≥ 35 g/L, stage III corresponding to beta-2-microglobulin ≥ 5.5 mg/L, and stage II when not stage I or III
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Serum rate of Lactate dehydrogenase
Measured in U/L; serum lactate dehydrogenase is a poor prognosis factor when elevated (> 300U/L)
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Salmon-Durie Plus classification
Based of the MRI pattern of multiple myeloma that determine three stages : stage I (0-4 focal lesions), stage II (5-20 focal lesions), stage III (>20 focal lesions). The subclassification depends on the absence (A) or the absence of extramedullary disease (B) (anemia, hypercalcemia, renal failure, amyloidosis)
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Type of bone damage on CT scan
Classified as normal, focal lesion, diffuse osteopenia, focal lesion with diffuse osteopenia
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Vertebral radiodensity
Measured by a CT scan in Hounsfield Units
Measured: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study startNov 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BOUSSON, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609150
- Sponsor's protocol ID
- APHP200091
- Status last verified
- Sep 2020
- First submitted
- 7 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04609150
- Acronym / sponsor ID
- APHP200091
- Conditions
- Multiple Myeloma, Vertebral Fracture
- Keywords
- Bone marrow fat, Bone fragility, Fat quantification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 30 Oct 2020 (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.
Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. The main objective is to assess the correlation between vertebral bone marrow fat fraction and bone fragility represented by a severity score of vertebral fractures. The secondary objective is to assess the correlation with clinical and biological prognostic factors and scores..
Detailed description
Patients treated with vertebroplasty will be included during the period of the study, retrospectively or prospectively.
Mains collected data are represented by :
- Bone marrow fat fraction determined by MRI
- Severity score for vertebral fractures
- Clinical prognostic factors
- Biological prognostic factors
- Clinico-biological scores Descriptive statistics and correlation analyses will be performed between the measured parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple myeloma patients with vertebral fractures | – | Other: Bone marrow fat quantification by MRIPatients followed for multiple myeloma in the Lariboisière/Saint-Louis/Fernand-Widal hospital group, with vertebral fractures treated by vertebroplasty from January 2017 to December 2021, with recent clinical and biological data available at the time of imaging and fracture events |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group, with vertebral fractures treated by vertebroplasty from January 2017 to December 2021, with recent clinical and biological data available at the time of imaging and fracture events.
Key inclusion criteria (3 listed)
- Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group
- vertebral fractures treated by vertebroplasty from January 2017 to December 2021
- recent clinical and biological data available at the time of imaging and fracture events
Key exclusion criteria (2 listed)
- Factors modifying the bone marrow fat fraction (extensive radiotherapy)
- Lack of recent clinical or biological data compared to imaging examinations
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 |
|---|---|---|
| Bone marrow fat quantification by MRIBone marrow fat quantification by MRI at the moment of the diagnosis of vertebral fracture before treatment by vertebroplasty | Other | Multiple myeloma patients with vertebral fractures |
Primary outcome
Percentage of bone marrow fat in vertebral bone marrow
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Measured from Dixon sequences on MRI exams performed in routine care, for the assessment of the relationship between bone marrow vertebral fat content and the severity of the vertebral fractures
Vertebral fracture severity score
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Score established according to morphological criteria determined by MRI/computerized tomography scan, based on the Genant classification. Calculation of sum of the points awarded as follows: vertebral fracture on osteolytic lesion = 3; osteolytic lesion with high fracture risk = 0; other fracture related to increased bone fragility, scale 1-3 according to Genant's criteria, 3 representing the worst situation; normal vertebra = 0.
17 secondary outcomes
Sex
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Age at the diagnosis of multiple myeloma
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Weight/body mass index (BMI)
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Age at the moment of the vertebral fracture
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Type of the monoclonal component
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Serum rate of the monoclonal component
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Medullary plasmacytosis
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of anaemia
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of hypercalcemia
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of renal failure related to myeloma
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of amyloidosis
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Multiple myeloma stage according to the Salmon-Durie staging System
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Multiple myeloma stage according to the International Staging System (ISS)
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Serum rate of Lactate dehydrogenase
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Salmon-Durie Plus classification
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Type of bone damage on CT scan
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Vertebral radiodensity
Time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Valérie BOUSSON, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Vertebral Fracture, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Nov 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregoire ATTANE, MD (+33 (0)688595952, gregoire_attane@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of bone marrow fat in vertebral bone marrow (time frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty). The study lists 2 primary outcomes in all. 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 6 Nov 2020.