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Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study"
Sponsor: Fondazione EMN Italy Onlus
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
92
Start Date
2026-08
Completion Date
2030-08
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (10)
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