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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04609150
Other study ID # APHP200091
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2020
Est. completion date June 2022

Study information

Verified date September 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Gregoire ATTANE, MD
Phone +33 (0)688595952
Email gregoire_attane@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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..


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Bone marrow fat quantification by MRI
Bone marrow fat quantification by MRI at the moment of the diagnosis of vertebral fracture before treatment by vertebroplasty

Locations

Country Name City State
France AP-HP, Lariboisière Hospital, Osteo-Articular, Visceral and Vascular Imaging department Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

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
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