This is a prospective, multicenter diagnostic imaging study designed to evaluate the diagnostic accuracy and clinical utility of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders. The study aims to non-invasively visualize and quantify whole-body BCMA expression and to assess its role in the detection of active disease and disease heterogeneity.
patients with suspected or previously diagnosed multiple myeloma (MM) who were scheduled for bone marrow aspiration or tissue biopsy within two weeks, including those undergoing initial diagnostic evaluation or follow-up/re-evaluation for disease monitoring or relapse;
patients with confirmed symptomatic MM;
ability to understand and voluntarily sign written informed consent;
ability to comply with study procedures;
pregnancy or lactation;
inability to comprehend study procedures or cooperate with protocol requirements;
any other condition judged by the investigator to potentially interfere with study participation.
Single group
68Ga-BCMA PET/CT
Diagnostic testIntravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol.
Diagnostic performance of 68Ga-BCMA PET/CT
To determine the diagnostic accuracy of BCMA PET/CT for detecting active myeloma lesions, using biopsy confirmation as the reference standard.
Safety of BCMA-targeted radiotracer
Number of participants experiencing adverse events and severity of adverse events following administration of the BCMA-targeted radiotracer, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers
Spearman correlation coefficients between lesion uptake on BCMA PET/CT and disease burden markers, including serum M-protein concentration, soluble BCMA levels, involved free light chain level, and bone marrow plasma cell percentage.
Detection of extramedullary disease
Impact on clinical management
Proportion of patients whose treatment strategy changed following BCMA-targeted PET/CT findings.
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Peking University First Hospital
Lead sponsor
The First Hospital of Jilin University
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Beijing Anzhen Hospital
Collaborator
Beijing Tsinghua Changgeng Hospital
Collaborator
