Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Patients With Multiple Myeloma

Conditions
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Multiple Myeloma, Vertebral Fracture

Intervention / Treatment
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* Other: Bone marrow fat quantification by MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Factors modifying the bone marrow fat fraction (extensive radiotherapy) Lack of recent clinical or biological data compared to imaging examinations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple myeloma patients with vertebral fractures<br>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 | Other: Bone marrow fat quantification by MRI<br>* Bone marrow fat quantification by MRI at the moment of the diagnosis of vertebral fracture before treatment by vertebroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex | Male or female | 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 | 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 | 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 | 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 | 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 | 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 | At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty | 
| Presence of anaemia | Defined by hemoglobin value < 100g/L | At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty | 
| Presence of hypercalcemia | Defined by serum calcium > 2.75mmol/L | 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 | 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 | 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). | 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 | 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) | 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) | 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 | At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty | 
| Vertebral radiodensity | Measured by a CT scan in Hounsfield Units | At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow fat, Bone fragility, Fat quantification