NCT Number: NCT07746232
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
IRCCS Istituto Tumori "G. Paolo II - U.O.C. Ematologia e Terapia Cellulare, Bari, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Minimum 2 years, up to 4 years
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
Defined as the time from the date of ASCT to death from any cause.
Time frame: Minimum 2 years, up to 4 years
Evaluation of survival outcomes based on the 17.2% rFF% threshold identified on residual focal skeletal lesions.
Time frame: 4 months post-ASCT
To assess RAC score in relation to response according to IMWG criteria
Time frame: Pre-maintenance (approx. 100 days post-ASCT)
Assessment of the agreement between radiological response (RAC score) and Minimal Residual Disease (MRD) status (when available).
Time frame: 18 months post-ASCT)
Proportion of participants with early relapse (within 18 months post-ASCT) associated with rFF% < 17.2%.
Time frame: Through study completion, an average of 2 years
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.
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.
Contact information is provided by the study sponsor or research team.
Fondazione EMN Italy Onlus
Other
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07740317
Blood Protein Disorders, CART Therapy
Charlotte, North Carolina, United States
View Trial DetailsNCT07740486
Blood Protein Disorders, Cardiovascular Diseases
View Trial DetailsNCT07735546
Blood Protein Disorders, Cardiovascular Diseases
View Trial DetailsNCT07687004
Blood Protein Disorders, Cardiovascular Diseases
Tianjin, China
View Trial Details