Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
|
Primary |
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 |
Sex |
Male or female |
At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Type of the monoclonal component |
Corresponding the type of the heavy (IgG, IgA, IgD, IgE or IgM) and/or the light chain (? or ?) of the monoclonal immunoglobulin protein |
At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Presence of anaemia |
Defined by hemoglobin value < 100g/L |
At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty |
|
Secondary |
Presence of hypercalcemia |
Defined by serum calcium > 2.75mmol/L |
At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
Vertebral radiodensity |
Measured by a CT scan in Hounsfield Units |
At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty |
|