Clinical trial · Observational
Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study"
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Data Collection | Other | — | UNRESOLVED |
| DW-MRI (MY-RADS/RAC score) | Diagnostic Test | — | UNRESOLVED |
| Fat Fraction (rFF%) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational: MM Patient Cohort
- description
- This cohort includes transplant-eligible patients with newly diagnosed multiple myeloma (NDMM) who have completed first-line anti-CD38-based quadruplet induction therapy and autologous stem cell transplantation (ASCT).
- interventionNames
- Diagnostic Test: DW-MRI (MY-RADS/RAC score)
- Diagnostic Test: Fat Fraction (rFF%)
- Other: Clinical Data Collection
Primary outcomes (1)
- measure
- Radiological Response Categories (RAC1 and RAC≥2)
- timeFrame
- Post-ASCT / Pre-maintenance (approx. 3-4 months after ASCT))
- description
- Prevalence of radiological response categories evaluated by post-ASCT DW-MRI according to MY-RADS criteria.
Secondary outcomes (8)
- measure
- Progression-Free Survival (PFS) according to RAC score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available