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

November 5, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 75010
        • Recruiting
        • AP-HP, Lariboisière Hospital, Osteo-Articular, Visceral and Vascular Imaging department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of bone marrow fat in vertebral bone marrow
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sex
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Male or female
At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Age at the diagnosis of multiple myeloma
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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)
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Defined by hemoglobin value < 100g/L
At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Presence of hypercalcemia
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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)
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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
Time Frame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valérie BOUSSON, MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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