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Clinical Trials in Italy / NCT07746232
Starting soon Observational

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

NCT07746232 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione EMN Italy Onlus
Phase
Observational
Started
2026-10
Last updated
2026-09-09

Condition(s) studied

Multiple Myeloma (MM)

Investigational drug(s) / intervention(s)

DW-MRI (MY-RADS/RAC score)Fat Fraction (rFF%)Clinical Data Collection

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.

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
IRCCS Istituto Tumori "G. Paolo II - U.O.C. Ematologia e Terapia Cellulare Bari Italy
A.O.U. di Bologna - Policlinico S. Orsola Malpighi Bologna Italy
A.O. Spedali Civili di Brescia Brescia Italy
Istituto Oncologico Veneto IRCCS - UOC Oncoematologia Castelfranco Veneto Italy
Ospedale Classificato Valduce Como Italy
I.R.C.C.S. Ospedale S. Raffaele Milan Italy
Ospedale Niguarda Milan Italy
A.O.U. Maggiore della Carità Novara Italy
Policlinico S. Matteo Fondazione IRCCS Pavia Italy
ASL Roma 1 Rome Italy

More Fondazione EMN Italy Onlus trials in Italy

A Trial for Relapsed and Relapsed/Refractory Multiple Myeloma Patients Active, not recruiting
A "Physician & Patient-powered" Cohort Registry (MY MYELOMA) Recruiting
A Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant Active, not recruiting

Other trials for the same condition

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab. Recruiting
Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers Recruiting
A Machine Learning Approach to Connect Multiple Myeloma Complexity to Early Disease Recurrence Recruiting
Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07746232 on ClinicalTrials.gov ↗ ← All trials in Italy