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Clinical Trial NCT07319897 for Multiple Myeloma, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Multiple Myeloma and Plasma Cell Neoplasm is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma. Phase 2, Phase 3 300 Non-Invasive

Not yet recruiting
Clinical Trial NCT07319897 is designed to study Diagnostic for Multiple Myeloma, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Multiple Myeloma and Plasma Cell Neoplasm. This Phase 2 Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 25 December 2025 until the study accrues 300 participants. Led by Peking University First Hospital, this study is expected to complete by 30 December 2027. The latest data from ClinicalTrials.gov was last updated on 6 January 2026.
Brief Summary
This is a prospective, multicenter, diagnostic imaging study designed to evaluate the diagnostic performance and clinical utility of BCMA-targeted Positron Emission Tomography/Computed Tomography (PET/CT) in patients with multiple myeloma and other palsma cell disorders. The study aims to non-invasively visualize and quantify the whole-body biodistribution of BCMA expression.
Official Title

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

Conditions
Multiple MyelomaMultiple Myeloma and Malignant Plasma Cell NeoplasmsMultiple Myeloma and Plasma Cell Neoplasm
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • PFBC01
NCT ID Number
NCT07319897
Start Date (Actual)
2025-12-25
Last Update Posted
2026-01-06
Completion Date (Estimated)
2027-12-30
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Not yet recruiting
Keywords
multiple myeloma
bcma
PET/CT
diagnosis
multicenter
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental68Ga-BCMA PET/CT
Every patient will receive 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
From enrollment to the end of PET/CT at 4 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

(1) 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; (2) patients with confirmed symptomatic MM; (3) ability to understand and voluntarily sign written informed consent; (4) ability to comply with study procedures; and (5) Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

pregnancy or lactation; inability to comprehend study procedures or cooperate with protocol requirements; or any other condition judged by the investigator to potentially interfere with study participation.
Peking University First Hospital logoPeking University First Hospital
Study Central Contact
Contact: Lei Kang, M.D, Ph.D, 86+13811486428, [email protected]
5 Study Locations in 1 Countries

Hebei

Beijing An Zhen Hospital of the Capital University of Medical Sciences, Beijingcun, Hebei, China
Yini Wang, M.D, Ph.D, Contact, 8613901086559, [email protected]
Yini Wang, M.D, Ph.D, Principal Investigator
Beijing Tsinghua Changgung Hospital, Beijingcun, Hebei, China
Lihong Li, M.D, Ph.D, Contact, 86 135 0139 0152, [email protected]
Lihong Li, M.D, Ph.D, Principal Investigator
Peking University First Hospital, Beijingcun, Hebei, China
Tingfei Dr. Gu, M.D, Ph.D, Contact, 8618513338311, [email protected]
Lei Kang, M.D, Ph.D, Principal Investigator
Yujun Dong, M.D, Ph.D, Principal Investigator
the Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Fuxu Wang, M.D, Ph.D, Contact, 8613931100360, [email protected]
Fuxu Wang, M.D, Ph.D, Principal Investigator

Jilin

First Hospital of Jilin University, Jilin, Jilin, China
Fengyan Jing, Contact, 8613844989638, [email protected]
Fengyan Jing, M.D, Ph.D, Principal Investigator