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
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Status | Recruiting |
| Started | December 25, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07319897 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.