Multiple Myeloma, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
multiple myeloma, bcma, PET/CT, diagnosis, multicenter
Brief summary
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.
Detailed description
This study is a prospective, multicenter diagnostic imaging investigation designed to evaluate the clinical value of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders across different disease states. Participants will undergo 68Ga-labeled BCMA PET/CT imaging in accordance with a standardized imaging protocol. Imaging findings will be assessed for the presence, distribution, and intensity of BCMA expression at both lesion-based and patient-based levels. Where clinically feasible, imaging findings will be correlated with histopathologic confirmation obtained from biopsy, which will serve as the reference standard for evaluation of diagnostic accuracy. In addition to lesion detection, this study will explore the relationship between BCMA PET/CT findings and established clinical, laboratory, and imaging parameters. These include conventional imaging modalities, indicators of disease burden, and minimal residual disease (MRD) assessments when available. Longitudinal clinical follow-up will be conducted to assess changes in imaging findings over time and their association with treatment response and disease status. In a subset of participants, circulating soluble BCMA (sBCMA) levels will be measured in peripheral blood samples collected within a predefined time window around the time of PET/CT imaging. Exploratory analyses will be performed to evaluate the association between sBCMA levels, imaging-derived measures of BCMA expression, and other indicators of disease burden. These analyses are intended to provide complementary biological context for imaging findings and to explore the potential role of integrating imaging and blood-based biomarkers in the assessment of multiple myeloma. By integrating advanced molecular imaging with clinical, pathological, and biological data, this study aims to characterize whole-body disease burden and heterogeneity in a non-invasive manner and to define the potential clinical utility of BCMA PET/CT for diagnosis, response assessment, and disease monitoring in multiple myeloma.
Interventions
DIAGNOSTIC_TEST68Ga-BCMA PET/CT
Intravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol.
Sponsors
Peking University First Hospital
The First Hospital of Jilin University
The Second Hospital of Hebei Medical University
Beijing Anzhen Hospital
Beijing Tsinghua Changgeng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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; * Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of 68Ga-BCMA PET/CT | From enrollment to the end of PET/CT at 4 weeks | 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 | Up to 30 days after tracer injection. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers | Within 2 weeks of PET/CT imaging | 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 | Baseline imaging assessment. | — |
| Impact on clinical management | Within 30 days after imaging. | Proportion of patients whose treatment strategy changed following BCMA-targeted PET/CT findings. |
Countries
China
Contacts
CONTACTLei Kang, M.D, Ph.D
PRINCIPAL_INVESTIGATORLei Kang, M.D, Ph.D
Peking University First Hospital
PRINCIPAL_INVESTIGATORYujun Dong, M.D, Ph.D
Peking University First Hospital
Outcome results
None listed