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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609150
• Other study ID #: APHP200091
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Spinal Fractures
• Vertebral Fracture

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