Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study" | NCT07746232

NCT07746232

Overview

NCT ID: NCT07746232
Lead Sponsor: Fondazione EMN Italy OnlusOTHER
Official Title: Multicenter Observational Study for the Validation of the Predictive Role of Diffusion-Weighted Whole-body MRI (DW-MRI) Imaging Response According to MY-RADS Criteria (RAC Score) and Fat Fraction (rFF%) After Autologous Stem Cell Transplantation in Multiple Myeloma Patients Treated With First-Line Anti-CD38-Based Therapy (RAC-FAT Study)
Brief 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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Aug 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion criteria:

Newly diagnosed MM participants eligible for ASCT, treated with anti-CD38-based quadruplet induction therapy and ASCT, with post-ASCT/premaintenance DW-MRI available (in tandem ASCT, DW-MRI after second ASCT will be considered).

Age ≥18 years.

Participant must sign an informed consent form (ICF) that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.

Exclusion Criteria:

- Absence of post-ASCT/pre-maintenance DW-MRI.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 92Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: FONDAZIONE EMN ITALY ETS FONDAZIONE EMN ITALY ETSContact
clinicaltrialoffice@emnitaly.org

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