Clinical trial · Interventional
68Ga-BCMA PET/CT in Multiple Myeloma
A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.
NCT07319897CI-TRIAL-00115346recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Multiple Myeloma and Malignant Plasma Cell Neoplasms | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-BCMA PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-BCMA PET/CT
- description
- Every patient will receive 68Ga-BCMA PET/CT
- interventionNames
- Diagnostic Test: 68Ga-BCMA PET/CT
Primary outcomes (2)
- measure
- Diagnostic performance of 68Ga-BCMA PET/CT
- timeFrame
- From enrollment to the end of PET/CT at 4 weeks
- description
- To determine the diagnostic accuracy of BCMA PET/CT for detecting active myeloma lesions, using biopsy confirmation as the reference standard.
- measure
- Safety of BCMA-targeted radiotracer
- timeFrame
- Up to 30 days after tracer injection.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTSong 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
- RESULTWang 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
- RESULTGu 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