Clinical trial Recruiting at 5 sites Phase2; Phase3 Interventional Ages 18 to 80

BCMA PET/CT to visualize myeloma and related plasma cell disorders

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

Run by Peking University First Hospital · NCT07319897 · Data updated 2026-11-12

A multicenter study tests whether 68Ga-BCMA PET/CT can noninvasively detect active multiple myeloma and related diseases in patients.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment300 (estimated)
SponsorPeking University First Hospital
Academic / other
Locations5 sites (Beijing, Beijing Municipality and 4 other locations)
StatusRecruiting
StartedDecember 25, 2025
Main results expectedDecember 30, 2027
Study endsDecember 30, 2027
Registry record updatedJune 22, 2026
Trial IDNCT07319897 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with suspected or diagnosed multiple myeloma or related plasma cell neoplasms, scheduled for bone marrow biopsy or biopsy/re-evaluation, and ECOG ≤ 2.

Probably not a fit

Patients with advanced disease where imaging findings do not alter management, or those unable to undergo PET/CT, may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter diagnostic imaging study evaluates the accuracy and clinical value of BCMA-targeted PET/CT for detecting disease in multiple myeloma and related plasma cell neoplasms. Participants receive 68Ga-BCMA PET/CT scans using a standardized protocol, with imaging findings compared to biopsy results when available. The study also explores how scan results relate to other clinical tests, imaging modalities, and disease burden, and tracks changes over time to relate imaging to treatment response. In a subset, soluble BCMA levels are measured to assess associations with imaging findings. Longitudinal follow-up aims to determine how BCMA PET/CT could influence clinical decision-making and disease monitoring.

Why it matters

Potential benefit: If successful, BCMA PET/CT could improve noninvasive detection and monitoring of myeloma activity and heterogeneity, potentially guiding treatment choices.

How similar studies have gone: Earlier work with targeted PET imaging in hematologic malignancies has shown promise, but this specific BCMA PET/CT approach in myeloma is being evaluated for diagnostic accuracy and clinical utility.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • 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

Study contacts

  • Principal investigator: Lei Kang, M.D, Ph.D — Peking University First Hospital
  • Study coordinator: Lei Kang, M.D, Ph.D
  • Email: kanglei@bjmu.edu.cn
  • Phone: 86+13811486428

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.