Multiple MyelomaPhase 2/3NCT07319897
68Ga-BCMA PET/CT in Multiple Myeloma
A Phase 2/3 study testing 68Ga-BCMA PET/CT in people with Multiple Myeloma and Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by Peking University First Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- 68Ga-BCMA PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- 25 Dec 2025to 30 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality
Yini Wang, M.D, Ph.D, 8613901086559, wangyini@ccmu.edu.cn
Yini Wang, M.D, Ph.D
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
Lihong Li, M.D, Ph.D, 86 135 0139 0152, llha03032@btch.edu.cn
Lihong Li, M.D, Ph.D
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Tingfei Dr. Gu, M.D, Ph.D, 8618513338311, tingfei.gu@ndm.ox.ac.uk
Lei Kang, M.D, Ph.D
- Recruiting
First Hospital of Jilin University
Jilin City, Jilin
Fengyan Jing, 8613844989638, fengyanjin@jlu.edu.cn
Fengyan Jing, M.D, Ph.D
- Recruiting
the Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Fuxu Wang, M.D, Ph.D, 8613931100360, wfxhebmu@163.com
Fuxu Wang, M.D, Ph.D
About this study
Official title: A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.
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.
Read the detailed description
This study is a prospective, multicenter diagnostic imaging investigation designed to evaluate the clinical value of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders across different disease states.
Participants will undergo 68Ga-labeled BCMA PET/CT imaging in accordance with a standardized imaging protocol. Imaging findings will be assessed for the presence, distribution, and intensity of BCMA expression at both lesion-based and patient-based levels. Where clinically feasible, imaging findings will be correlated with histopathologic confirmation obtained from biopsy, which will serve as the reference standard for evaluation of diagnostic accuracy.
In addition to lesion detection, this study will explore the relationship between BCMA PET/CT findings and established clinical, laboratory, and imaging parameters. These include conventional imaging modalities, indicators of disease burden, and minimal residual disease (MRD) assessments when available. Longitudinal clinical follow-up will be conducted to assess changes in imaging findings over time and their association with treatment response and disease status.
In a subset of participants, circulating soluble BCMA (sBCMA) levels will be measured in peripheral blood samples collected within a predefined time window around the time of PET/CT imaging. Exploratory analyses will be performed to evaluate the association between sBCMA levels, imaging-derived measures of BCMA expression, and other indicators of disease burden. These analyses are intended to provide complementary biological context for imaging findings and to explore the potential role of integrating imaging and blood-based biomarkers in the assessment of multiple myeloma.
By integrating advanced molecular imaging with clinical, pathological, and biological data, this study aims to characterize whole-body disease burden and heterogeneity in a non-invasive manner and to define the potential clinical utility of BCMA PET/CT for diagnosis, response assessment, and disease monitoring in multiple myeloma.
- Conditions
- Multiple Myeloma, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- 68Ga-BCMA PET/CT
- Keywords
- multiple myeloma, bcma, PET/CT, diagnosis, multicenter
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-BCMA PET/CTDiagnostic test
Intravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-BCMA PET/CT | Experimental | Every patient will receive 68Ga-BCMA PET/CT Receives: Diagnostic Test: 68Ga-BCMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 30 days after tracer injection.
Secondary outcomes (3)
Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers
Spearman correlation coefficients between lesion uptake on BCMA PET/CT and disease burden markers, including serum M-protein concentration, soluble BCMA levels, involved free light chain level, and bone marrow plasma cell percentage.
Measured: Within 2 weeks of PET/CT imaging
Detection of extramedullary disease
Measured: Baseline imaging assessment.
Impact on clinical management
Proportion of patients whose treatment strategy changed following BCMA-targeted PET/CT findings.
Measured: Within 30 days after imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start25 Dec 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, The Second Hospital of Hebei Medical University, Beijing Anzhen Hospital, Beijing Tsinghua Changgeng Hospital
- Responsible party
- Sponsor
- Investigators
- Lei Kang, M.D, Ph.D, Principal investigator, Peking University First HospitalYujun Dong, M.D, Ph.D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319897
- Sponsor's protocol ID
- PFBC01
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The current approved study protocol and informed consent documents do not include provisions for broad sharing of individual participant data with external researchers. The data generated in this study are complex, integrating detailed clinical information with advanced imaging biomarkers, and contain potentially identifiable and sensitive health information. Preparing these data for public sharing would require substantial additional resources and governance frameworks beyond the scope of the present study. De-identified data may be made available for collaborative research upon reasonable request to the Principal Investigator, subject to scientific review and execution of appropriate data use and transfer agreements, and in accordance with applicable regulations and institutional policies.
Publications
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.
PubMed 39167092Wang 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.
PubMed 40558019Gu 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.
PubMed 41239440
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT07319897
- Acronym / sponsor ID
- PFBC01
- Conditions
- Multiple Myeloma, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- multiple myeloma, bcma, PET/CT, diagnosis, multicenter
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, The Second Hospital of Hebei Medical University, Beijing Anzhen Hospital, Beijing Tsinghua Changgeng Hospital
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, multicenter diagnostic imaging investigation designed to evaluate the clinical value of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders across different disease states.
Participants will undergo 68Ga-labeled BCMA PET/CT imaging in accordance with a standardized imaging protocol. Imaging findings will be assessed for the presence, distribution, and intensity of BCMA expression at both lesion-based and patient-based levels. Where clinically feasible, imaging findings will be correlated with histopathologic confirmation obtained from biopsy, which will serve as the reference standard for evaluation of diagnostic accuracy.
In addition to lesion detection, this study will explore the relationship between BCMA PET/CT findings and established clinical, laboratory, and imaging parameters. These include conventional imaging modalities, indicators of disease burden, and minimal residual disease (MRD) assessments when available. Longitudinal clinical follow-up will be conducted to assess changes in imaging findings over time and their association with treatment response and disease status.
In a subset of participants, circulating soluble BCMA (sBCMA) levels will be measured in peripheral blood samples collected within a predefined time window around the time of PET/CT imaging. Exploratory analyses will be performed to evaluate the association between sBCMA levels, imaging-derived measures of BCMA expression, and other indicators of disease burden. These analyses are intended to provide complementary biological context for imaging findings and to explore the potential role of integrating imaging and blood-based biomarkers in the assessment of multiple myeloma.
By integrating advanced molecular imaging with clinical, pathological, and biological data, this study aims to characterize whole-body disease burden and heterogeneity in a non-invasive manner and to define the potential clinical utility of BCMA PET/CT for diagnosis, response assessment, and disease monitoring in multiple myeloma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-BCMA PET/CT | Experimental | Diagnostic Test: 68Ga-BCMA PET/CTEvery patient will receive 68Ga-BCMA PET/CT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-BCMA PET/CTIntravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol. | Diagnostic test | 68Ga-BCMA PET/CT |
Primary outcome
Diagnostic performance of 68Ga-BCMA PET/CT
Time frame: From enrollment to the end of PET/CT at 4 weeks
To determine the diagnostic accuracy of BCMA PET/CT for detecting active myeloma lesions, using biopsy confirmation as the reference standard.
Safety of BCMA-targeted radiotracer
Time frame: Up to 30 days after tracer injection.
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.
3 secondary outcomes
Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers
Time frame: Within 2 weeks of PET/CT imaging
Detection of extramedullary disease
Time frame: Baseline imaging assessment.
Impact on clinical management
Time frame: Within 30 days after imaging.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Results publication: PubMed 39167092Song 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.
- Results publication: PubMed 40558019Wang 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.
- Results publication: PubMed 41239440Gu 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.
- Individual participant dataSharing planned: No. The current approved study protocol and informed consent documents do not include provisions for broad sharing of individual participant data with external researchers. The data generated in this study are complex, integrating detailed clinical information with advanced imaging biomarkers, and contain potentially identifiable and sensitive health information. Preparing these data for public sharing would require substantial additional resources and governance frameworks beyond the scope of the present study. De-identified data may be made available for collaborative research upon reasonable request to the Principal Investigator, subject to scientific review and execution of appropriate data use and transfer agreements, and in accordance with applicable regulations and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Kang, M.D, Ph.D principal investigator
Peking University First Hospital
Yujun Dong, M.D, Ph.D principal investigator
Peking University First Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 68Ga-BCMA PET/CT in people with Multiple Myeloma and Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by Peking University First Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Kang, M.D, Ph.D (86+13811486428, kanglei@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of 68Ga-BCMA PET/CT (time frame: From enrollment to the end of PET/CT at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07319897, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.