Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study"

NCT07746232 | Not Yet Recruiting

• 1 other identifier: RAC-FAT
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 10

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Radiological Response Categories (RAC1 and RAC≥2)

  Prevalence of radiological response categories evaluated by post-ASCT DW-MRI according to MY-RADS criteria.

  Post-ASCT / Pre-maintenance (approx. 3-4 months after ASCT))

Secondary Outcomes (8)

• Progression-Free Survival (PFS) according to RAC score

  Minimum 2 years, up to 4 years

• Overall Survival (OS) according to RAC score

  Minimum 2 years, up to 4 years

• PFS and OS according to relative Fat Fraction (rFF%)

  Minimum 2 years, up to 4 years

• RAC Score and IMWG Response Concordance

  4 months post-ASCT

• Concordance between RAC score and bone marrow MRD

  Pre-maintenance (approx. 100 days post-ASCT)

Study Arms (1)

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).

Diagnostic Test: DW-MRI (MY-RADS/RAC score); Diagnostic Test: Fat Fraction (rFF%); Other: Clinical Data Collection

Interventions

Clinical Data Collection OTHER

Retrospective and prospective collection of clinical outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Minimal Residual Disease (MRD) status from medical records.

Observational: MM Patient Cohort

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.

Observational: MM Patient Cohort

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.

Observational: MM Patient Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \- Absence of post-ASCT/pre-maintenance DW-MRI.

Sponsors & Collaborators

• Fondazione EMN Italy Onlus: lead

Study Sites (10)

IRCCS Istituto Tumori "G. Paolo II - U.O.C. Ematologia e Terapia Cellulare

Bari, Italy

Location

A.O.U. di Bologna - Policlinico S. Orsola Malpighi

Bologna, Italy

Location

A.O. Spedali Civili di Brescia

Brescia, Italy

Location

Istituto Oncologico Veneto IRCCS - UOC Oncoematologia

Castelfranco Veneto, Italy

Location

Ospedale Classificato Valduce

Como, Italy

Location

I.R.C.C.S. Ospedale S. Raffaele

Milan, Italy

Location

Ospedale Niguarda

Milan, Italy

Location

A.O.U. Maggiore della Carità

Novara, Italy

Location

Policlinico S. Matteo Fondazione IRCCS

Pavia, Italy

Location

ASL Roma 1

Rome, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

FONDAZIONE EMN ITALY ETS FONDAZIONE EMN ITALY ETS

CONTACT

+390110243236; clinicaltrialoffice@emnitaly.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 4, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)