An observational study in Multiple Myeloma (MM), sponsored by Fondazione EMN Italy Onlus. Not yet recruiting at 10 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Fondazione EMN Italy Onlus · Observational
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.
The role of functional imaging in Multiple Myeloma (MM) has become essential for assessing treatment response. This study focuses on the Myeloma Response Assessment and Diagnosis System (MY-RADS) guidelines and the quantitative parameter of rFF% to identify "functional high-risk" patients who may experience early relapse despite achieving conventional deep responses.The study will involve two cohorts:Retrospective Cohort: Includes patients treated since January 1st, 2020, with available post-ASCT DW-MRI data performed during routine clinical practice.Prospective Cohort: Includes newly diagnosed patients enrolled after their standard-of-care ASCT and post-transplant DW-MRI assessment.Participants will not receive any investigational or trial-specific treatment. All diagnostic and therapeutic procedures follow the current standard of care. Data regarding clinical characteristics, treatment details (induction, ASCT, maintenance), DW-MRI parameters (RAC score, apparent diffusion coefficient [ADC], and rFF% values), and minimal residual disease (MRD) will be collected and recorded in an anonymized electronic Case Report Form (eCRF).The study aims to enroll a minimum of 92 participants to evaluate:Primary Endpoint: Prevalence of RAC1 and RAC≥2 categories post-ASCT.Secondary Endpoints: Progression-free survival (PFS) and Overall Survival (OS) stratified by RAC score and rFF%, and the concordance between imaging results and bone marrow MRD.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 92 is below the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Fondazione EMN Italy Onlus is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Absence of post-/pre-maintenance DW-MRI.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Diagnostic Test: DW-MRI (MY-RADS/RAC score) · Diagnostic Test: Fat Fraction (rFF%) · Other: Clinical Data Collection
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.
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.
Retrospective 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.
Time frame: Post-ASCT / Pre-maintenance (approx. 3-4 months after ASCT))
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.
Time frame: Minimum 2 years, up to 4 years
Overall Survival (OS) according to RAC score
Defined as the time from the date of ASCT to death from any cause.
Time frame: Minimum 2 years, up to 4 years
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.
Time frame: Minimum 2 years, up to 4 years
RAC Score and IMWG Response Concordance
To assess RAC score in relation to response according to IMWG criteria
Time frame: 4 months post-ASCT
Concordance between RAC score and bone marrow MRD
Assessment of the agreement between radiological response (RAC score) and Minimal Residual Disease (MRD) status (when available).
Time frame: Pre-maintenance (approx. 100 days post-ASCT)
Early Relapse Rate and rFF%
Proportion of participants with early relapse (within 18 months post-ASCT) associated with rFF% \< 17.2%.
Time frame: 18 months post-ASCT)
PFS by Combined MRD and RAC Score
Evaluation of post-ASCT progression-free survival (PFS) stratified by the combined assessment of bone marrow minimal residual disease (MRD) status and radiological Response Assessment Category (RAC) score.
Time frame: Through study completion, an average of 2 years
OS by Combined MRD and RAC Score
Evaluation of post-ASCT overall survival (OS) stratified by the combined assessment of bone marrow minimal residual disease (MRD) status and radiological Response Assessment Category (RAC) score.
Time frame: Through study completion, an average of 2 years.
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fondazione EMN Italy Onlus