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Clinical Trials in China / NCT07319897
Recruiting Phase 2/3

68Ga-BCMA PET/CT in Multiple Myeloma

NCT07319897 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Phase 2/3
Started
2025-12-25
Last updated
2026-06-22

Condition(s) studied

Multiple MyelomaMultiple Myeloma and Malignant Plasma Cell NeoplasmsMultiple Myeloma and Plasma Cell Neoplasm

Investigational drug(s) / intervention(s)

68Ga-BCMA PET/CT

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.

Trial sites (5)

FacilityCityRegionStatus
Beijing An Zhen Hospital of the Capital University of Medical Sciences Beijing Beijing Municipality Recruiting
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality Recruiting
Peking University First Hospital Beijing Beijing Municipality Recruiting
the Second Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
First Hospital of Jilin University Jilin City Jilin Recruiting

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BBM-L101 Gene Therapy in Participants With LGMD2D/R3 Starting soon

Other trials for the same condition

Study of CT071 Injection in RRMM or PPCL Active, not recruiting
Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients Recruiting
Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection Recruiting
A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma Recruiting
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07319897 on ClinicalTrials.gov ↗ ← All trials in China