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Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study"

NCT07746232 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2026-08-04

No results posted yet for this study

Summary

This is a multicenter, observational, retrospective-prospective study designed to validate the predictive role of advanced imaging in patients with newly diagnosed multiple myeloma (NDMM). The main purpose of this study is to estimate the prevalence of radiological response categories (Response Assessment Category, RAC score) and evaluate the predictive value of relative Fat Fraction (rFF%) using Diffusion-Weighted Whole-Body Magnetic Resonance Imaging (DW-MRI) in patients who have undergone autologous stem cell transplantation (ASCT) after receiving first-line anti-CD38-based quadruplet induction therapy.

Conditions

  • Multiple Myeloma (MM)

Interventions

DIAGNOSTIC_TEST

DW-MRI (MY-RADS/RAC score)

Collection and analysis of Diffusion-Weighted Whole-body MRI data performed post-ASCT. The radiological response is evaluated using the Response Assessment Category (RAC) score (1 to 5) according to MY-RADS criteria.

DIAGNOSTIC_TEST

Fat Fraction (rFF%)

Quantitative assessment of the relative Fat Fraction (percentage of fat within skeletal regions) measured on residual focal lesions after transplantation to identify functional high-risk (FHR) patients.

OTHER

Clinical Data Collection

Retrospective and prospective collection of clinical outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Minimal Residual Disease (MRD) status from medical records.

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2030-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07746232 on ClinicalTrials.gov