68Ga-BCMA PET/CT in Multiple Myeloma

NCT07319897 | Recruiting Phase 2

• 1 other identifier: PFBC01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

multiple myeloma; bcma; PET/CT; diagnosis; multicenter

Outcome Measures

Primary Outcomes (2)

• 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

• Safety of BCMA-targeted radiotracer

  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 Outcomes (3)

• Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers

  Within 2 weeks of PET/CT imaging

• Detection of extramedullary disease

  Baseline imaging assessment.

• Impact on clinical management

  Within 30 days after imaging.

Study Arms (1)

68Ga-BCMA PET/CT

EXPERIMENTAL

Every patient will receive 68Ga-BCMA PET/CT

Diagnostic Test: 68Ga-BCMA PET/CT

Interventions

68Ga-BCMA PET/CT DIAGNOSTIC_TEST

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

68Ga-BCMA PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• The First Hospital of Jilin University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Beijing Anzhen Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator

Study Sites (5)

Beijing An Zhen Hospital of the Capital University of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

the Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

First Hospital of Jilin University

Jilin City, Jilin, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 39167092 RESULT

• 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.

  PMID: 40558019 RESULT

• 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.

  PMID: 41239440 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lei Kang, M.D, Ph.D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Yujun Dong, M.D, Ph.D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Kang, M.D, Ph.D

CONTACT

86+13811486428; kanglei@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)