NCT07319897 68Ga-BCMA PET/CT in Multiple Myeloma
| NCT ID | NCT07319897 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Peking University First Hospital |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-12-25 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2025-12-25 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Lei Kang, M.D, Ph.D
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT07319897 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07319897 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07319897 currently recruiting?
Yes, NCT07319897 is actively recruiting participants. Contact the research team at kanglei@bjmu.edu.cn for enrollment information.
Where is the NCT07319897 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Shijiazhuang, China and 1 additional location.
Who is sponsoring the NCT07319897 clinical trial?
NCT07319897 is sponsored by Peking University First Hospital. The principal investigator is Lei Kang, M.D, Ph.D at Peking University First Hospital. The trial plans to enroll 300 participants.