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

NCT04609150 | Unknown

• 1 other identifier: APHP200091
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

Multiple Myeloma; Vertebral Fracture

Keywords

Bone marrow fat; Bone fragility; Fat quantification

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Sex

  At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty

• Age 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)

  At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty

• Age 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

  At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty

Study Arms (1)

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

Interventions

Bone marrow fat quantification by MRI OTHER

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

Multiple myeloma patients with vertebral fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Factors modifying the bone marrow fat fraction (extensive radiotherapy)
• Lack of recent clinical or biological data compared to imaging examinations

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Lariboisière Hospital, Osteo-Articular, Visceral and Vascular Imaging department

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Spinal Fractures

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Valérie BOUSSON, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregoire ATTANE, MD

CONTACT

+33 (0)688595952; gregoire_attane@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 30, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 1, 2022
• Last Updated: November 6, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)