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

NCT ID: NCT07319897

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-25

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma Multiple Myeloma and Malignant Plasma Cell Neoplasms Multiple Myeloma and Plasma Cell Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-BCMA PET/CT

Every patient will receive 68Ga-BCMA PET/CT

Group Type EXPERIMENTAL

68Ga-BCMA PET/CT

Intervention Type DIAGNOSTIC_TEST

Intravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

(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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Beijing Tsinghua Changgeng Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lei Kang, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Yujun Dong, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Beijing An Zhen Hospital of the Capital University of Medical Sciences

Beijingcun, Hebei, China

Site Status

Beijing Tsinghua Changgung Hospital

Beijingcun, Hebei, China

Site Status

Peking University First Hospital

Beijingcun, Hebei, China

Site Status

the Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

First Hospital of Jilin University

Jilin, Jilin, China

Site Status

Countries

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China

Central Contacts

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Lei Kang, M.D, Ph.D

Role: CONTACT

86+13811486428

Facility Contacts

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Yini Wang, M.D, Ph.D

Role: primary

8613901086559

Lihong Li, M.D, Ph.D

Role: primary

86 135 0139 0152

Tingfei Dr. Gu, M.D, Ph.D

Role: primary

8618513338311

Fuxu Wang, M.D, Ph.D

Role: primary

8613931100360

Fengyan Jing

Role: primary

8613844989638

References

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Song L, Jiang S, Yang Q, Huang W, Qiu Y, Chen Z, Sun X, Wang T, Wu S, Chen Y, Zeng H, Wang Z, Kang L. Development of a Novel Peptide-Based PET Tracer [68Ga]Ga-DOTA-BP1 for BCMA Detection in Multiple Myeloma. J Med Chem. 2024 Sep 12;67(17):15118-15130. doi: 10.1021/acs.jmedchem.4c00759. Epub 2024 Aug 21.

Reference Type RESULT
PMID: 39167092 (View on PubMed)

Wang T, Yang Q, Huang W, Sun X, Lei Y, Xu H, Song L, Duan X, Liu F, Wang W, Bao Z, Gao J, Wang F, Kang L. Development and Preclinical Validation of a Novel 89Zr-Labeled BCMA-Targeting Antibody for ImmunoPET Imaging: Application in Multiple Myeloma Models and First-In-Nonhuman-Primates. J Med Chem. 2025 Jul 24;68(14):14843-14858. doi: 10.1021/acs.jmedchem.5c01010. Epub 2025 Jun 25.

Reference Type RESULT
PMID: 40558019 (View on PubMed)

Gu T, Chen Z, Wang T, Dong Y, Kang L. B-cell maturation antigen targeted PET/CT imaging in multiple myeloma: a first-in-human study. J Hematol Oncol. 2025 Nov 14;18(1):101. doi: 10.1186/s13045-025-01758-3.

Reference Type RESULT
PMID: 41239440 (View on PubMed)

Other Identifiers

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PFBC01

Identifier Type: -

Identifier Source: org_study_id

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