Multiple Myeloma (MM)NCT07746232
Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study"
An observational study of Multiple Myeloma (MM), run by Fondazione EMN Italy Onlus at 10 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- DW-MRI (MY-RADS/RAC score), Fat Fraction (rFF%) and Clinical Data Collection
- How many people
- 92 participants
- Where
- 10 sitesItaly
- Study dates
- Oct 2026to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Absence of post-ASCT/pre-maintenance DW-MRI.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
FONDAZIONE EMN ITALY ETS FONDAZIONE EMN ITALY ETS contact
10 sites in 1 country
Italy10 sites
IRCCS Istituto Tumori "G. Paolo II - U.O.C. Ematologia e Terapia Cellulare
Bari
A.O.U. di Bologna - Policlinico S. Orsola Malpighi
Bologna
A.O. Spedali Civili di Brescia
Brescia
Angelo Belotti, ange.belotti@gmail.com
Istituto Oncologico Veneto IRCCS - UOC Oncoematologia
Castelfranco Veneto
Massimiliano Arangio Febbo, massimiliano.arangiofebbo@iov.veneto.it
Ospedale Classificato Valduce
Como
Francesca Guidotti, fguidotti@valduce.it
I.R.C.C.S. Ospedale S. Raffaele
Milan
Francesca Farina, farina.francesca@hsr.it
Ospedale Niguarda
Milan
Maria Luisa Pioltelli, MariaLuisa.Pioltelli@ospedaleniguarda.it
A.O.U. Maggiore della Carità
Novara
Paola Boggione, paola.boggione@uniupo.it
Policlinico S. Matteo Fondazione IRCCS
Pavia
Silvia Mangiacavalli, silvia.mangiacavalli@gmail.com
ASL Roma 1
Rome
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- DW-MRI (MY-RADS/RAC score), Fat Fraction (rFF%), Clinical Data Collection
- Keywords
- Newly diagnosed multiple myeloma (NDMM), Transplant-eligible (TE), Diffusion-weighted whole-body MRI (DW-MRI), MY-RADS criteria, Response Assessment Category (RAC score), Fat Fraction (rFF%), Autologous Stem Cell Transplantation (ASCT), Anti-CD38-based therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-MRI (MY-RADS/RAC score)Diagnostic test
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%)Diagnostic test
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 CollectionOther
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 group | Role | What they receive |
|---|---|---|
| Observational: MM Patient Cohort | 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). Receives: Diagnostic Test: DW-MRI (MY-RADS/RAC score); Diagnostic Test: Fat Fraction (rFF%); Other: Clinical Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Response Categories (RAC1 and RAC≥2)
Prevalence of radiological response categories evaluated by post-ASCT DW-MRI according to MY-RADS criteria.
Measured: Post-ASCT / Pre-maintenance (approx. 3-4 months after ASCT))
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione EMN Italy Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746232
- Sponsor's protocol ID
- RAC-FAT
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07746232
- Acronym / sponsor ID
- RAC-FAT
- Conditions
- Multiple Myeloma (MM)
- Keywords
- Newly diagnosed multiple myeloma (NDMM), Transplant-eligible (TE), Diffusion-weighted whole-body MRI (DW-MRI), MY-RADS criteria, Response Assessment Category (RAC score), Fat Fraction (rFF%), Autologous Stem Cell Transplantation (ASCT), Anti-CD38-based therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fondazione EMN Italy OnlusUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational: MM Patient Cohort | – | Diagnostic Test: DW-MRI (MY-RADS/RAC score), Diagnostic Test: Fat Fraction (rFF%), Other: Clinical Data CollectionThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Absence of post-ASCT/pre-maintenance DW-MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Observational: MM Patient Cohort |
| 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. | Diagnostic test | Observational: MM Patient Cohort |
| Clinical Data CollectionRetrospective and prospective collection of clinical outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Minimal Residual Disease (MRD) status from medical records. | Other | Observational: MM Patient Cohort |
Primary outcome
Radiological Response Categories (RAC1 and RAC≥2)
Time frame: Post-ASCT / Pre-maintenance (approx. 3-4 months after ASCT))
Prevalence of radiological response categories evaluated by post-ASCT DW-MRI according to MY-RADS criteria.
8 secondary outcomes
Progression-Free Survival (PFS) according to RAC score
Time frame: Minimum 2 years, up to 4 years
Overall Survival (OS) according to RAC score
Time frame: Minimum 2 years, up to 4 years
PFS and OS according to relative Fat Fraction (rFF%)
Time frame: Minimum 2 years, up to 4 years
RAC Score and IMWG Response Concordance
Time frame: 4 months post-ASCT
Concordance between RAC score and bone marrow MRD
Time frame: Pre-maintenance (approx. 100 days post-ASCT)
Early Relapse Rate and rFF%
Time frame: 18 months post-ASCT)
PFS by Combined MRD and RAC Score
Time frame: Through study completion, an average of 2 years
OS by Combined MRD and RAC Score
Time frame: Through study completion, an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FONDAZIONE EMN ITALY ETS FONDAZIONE EMN ITALY ETS contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma (MM), run by Fondazione EMN Italy Onlus at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FONDAZIONE EMN ITALY ETS FONDAZIONE EMN ITALY ETS (+390110243236, clinicaltrialoffice@emnitaly.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological Response Categories (RAC1 and RAC≥2) (time frame: Post-ASCT / Pre-maintenance (approx. 3-4 months after ASCT))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.