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

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..

Study Overview

• Status: Unknown
• Conditions: Multiple Myeloma; Vertebral Fracture
• Intervention / Treatment: Other: Bone marrow fat quantification by MRI

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • AP-HP, Lariboisière Hospital, Osteo-Articular, Visceral and Vascular Imaging department
    • Contact: Gregoire ATTANE, MD; Phone Number: +33 (0)688595952; Email: gregoire_attane@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Valérie BOUSSON, MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (ACTUAL): October 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Bone fragility; Bone marrow fat; Fat quantification
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Fractures, Bone; Wounds and Injuries; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Spinal Injuries; Back Injuries; Multiple Myeloma; Neoplasms, Plasma Cell; Spinal Fractures
• Other Study ID Numbers: APHP200091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No