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.
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.
None
The study population consists of adult patients with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for transplantation and have been treated according to the most recent standards of care.
Other
Other
DW-MRI (MY-RADS/RAC score)
Diagnostic testCollection 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%)
Diagnostic testQuantitative 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
Other interventionRetrospective and prospective collection of clinical outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Minimal Residual Disease (MRD) status from medical records.
Radiological Response Categories (RAC1 and RAC≥2)
Prevalence of radiological response categories evaluated by post-ASCT DW-MRI according to MY-RADS criteria.
Progression-Free Survival (PFS) according to RAC score
Defined as the time from the date of ASCT to the first documented disease progression (per IMWG criteria) or death from any cause.
Overall Survival (OS) according to RAC score
Defined as the time from the date of ASCT to death from any cause.
PFS and OS according to relative Fat Fraction (rFF%)
Evaluation of survival outcomes based on the 17.2% rFF% threshold identified on residual focal skeletal lesions.
RAC Score and IMWG Response Concordance
To assess RAC score in relation to response according to IMWG criteria
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