68Ga-BCMA PET/CT in Multiple Myeloma

June 16, 2026 updated by: Peking University First Hospital

A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Lei Kang, M.D, Ph.D
        • Principal Investigator:
          • Yujun Dong, M.D, Ph.D
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
        • Principal Investigator:
          • Lihong Li, M.D, Ph.D
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing An Zhen Hospital of the Capital University of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Yini Wang, M.D, Ph.D
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
        • Principal Investigator:
          • Fuxu Wang, M.D, Ph.D
    • Jilin
      • Jilin City, Jilin, China
        • Recruiting
        • First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Fengyan Jing, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-BCMA PET/CT
Every patient will receive 68Ga-BCMA PET/CT
Diagnostic test: 68Ga-BCMA PET/CT
Intravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of 68Ga-BCMA PET/CT
Time Frame: 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.
From enrollment to the end of PET/CT at 4 weeks
Safety of BCMA-targeted radiotracer
Time Frame: 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.
Up to 30 days after tracer injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers
Time Frame: 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.
Within 2 weeks of PET/CT imaging
Detection of extramedullary disease
Time Frame: Baseline imaging assessment.
Baseline imaging assessment.
Impact on clinical management
Time Frame: Within 30 days after imaging.
Proportion of patients whose treatment strategy changed following BCMA-targeted PET/CT findings.
Within 30 days after imaging.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

The Second Hospital of Hebei Medical University
Beijing Anzhen Hospital
The First Hospital of Jilin University
Beijing Tsinghua Changgeng Hospital

Investigators

  • Principal Investigator: Lei Kang, M.D, Ph.D, Peking University First Hospital
  • Principal Investigator: Yujun Dong, M.D, Ph.D, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

December 20, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFBC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The current approved study protocol and informed consent documents do not include provisions for broad sharing of individual participant data with external researchers. The data generated in this study are complex, integrating detailed clinical information with advanced imaging biomarkers, and contain potentially identifiable and sensitive health information. Preparing these data for public sharing would require substantial additional resources and governance frameworks beyond the scope of the present study.

De-identified data may be made available for collaborative research upon reasonable request to the Principal Investigator, subject to scientific review and execution of appropriate data use and transfer agreements, and in accordance with applicable regulations and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on 68Ga-BCMA PET/CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe