This clinical trial determines the effectiveness of whole body magnetic resonance imaging (MRI) in detecting and assessing treatment response in multiple myeloma. MRI is a method that collects images of the inside of the body. Diagnostic procedures such as whole-body MRI, may help find and diagnose multiple myeloma, find out how far the disease has spread, and help measure a patient's response to earlier treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04493411.
PRIMARY OBJECTIVE:
I. To prospectively determine the sensitivity, specificity, and diagnostic accuracy of whole-body MRI with dual-echo T2-weighted acquisition for enhanced conspicuity of tumors (DETECT) for the detection of multiple myeloma.
SECONDARY OBJECTIVES:
I. To prospectively compare the sensitivity, specificity, and diagnostic accuracy of whole-body MRI with DETECT to whole-body MRI with diffusion, and whole-body x-ray.
II. To prospectively compare therapy response assessment of whole-body MRI with current standard of care including whole-body x-ray, blood and urine analysis.
III. To evaluate the prognostic impact of whole-body MRI (WBMRI) at baseline, after 4-6 cycles of induction therapy, and before maintenance therapy compared to fludeoxyglucose F-18 (FDG)-positron emission tomography (PET).
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive gadobutrol or gadoterate meglumine and FDG then undergo WBMRI over 60-90 minutes and PET/computed tomography (CT) over 60 minutes, respectively, at baseline. Patients also undergo standard of care whole-body x-ray and bone marrow biopsy (BMB).
GROUP B: Patients receive gadobutrol or gadoterate meglumine and FDG then undergo WBMRI over 60-90 minutes and PET/CT over 60 minutes, respectively, at baseline, before bone marrow transplant (BMT), if clinically indicated, or consolidation (between weeks 12-24), before starting maintenance therapy (between weeks 24-36) and approximately 9 months after starting maintenance therapy (between weeks 60-72). Patients also undergo standard of care whole-body x-ray and BMB.
After completion of study treatment, patients are followed up periodically for up to 3 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorAnanth J. Madhuranthakam