Multiple Myeloma (MM)NCT07353554
Application Study of 68Ga-NOTA-BCMA Nanoantibody Imaging in Multiple Myeloma
A study testing 68Ga-BCMA nanobody PET/CT and 18F-FDG PET/CT in people with Multiple Myeloma (MM), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study intends to employ 68Ga-NOTA-BCMA nanobody PET/CT imaging in patients with multiple myeloma to evaluate the feasibility of this technique for myeloma assessment, analyze the correlation between 68Ga-NOTA-BCMA nanobody uptake intensity and disease staging, tumor burden, and prognosis, explore its value in… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- 68Ga-BCMA nanobody PET/CT and 18F-FDG PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed or relapsed MM patients
- Written informed consent obtained and capable of undergoing follow-up.
Who cannot join
- Severely abnormal liver and kidney function
- Women who are planning pregnancy, are pregnant, or are breastfeeding, as well as those with childcare plans during the study period; subjects of childbearing potential must use effective contraceptive measures throughout the study.
- Individuals unable to lie flat for 30 minutes.
- Individuals who decline to participate in this clinical study.
- Patients with claustrophobia or other psychiatric disorders, or poor compliance that may compromise their ability to cooperate with the study procedures.
- Other circumstances deemed by the investigator as unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study intends to employ 68Ga-NOTA-BCMA nanobody PET/CT imaging in patients with multiple myeloma to evaluate the feasibility of this technique for myeloma assessment, analyze the correlation between 68Ga-NOTA-BCMA nanobody uptake intensity and disease staging, tumor burden, and prognosis, explore its value in assessing treatment response and predicting early relapse, and compare its detection rate for myeloma lesions with that of 18F-FDG PET/CT. The results of this study may provide a more sensitive and specific imaging diagnostic method for patients with multiple myeloma and offer a basis for the individualized selection of future BCMA-targeted therapies. This study has been approved by the Ethics Committee of Peking Union Medical College Hospital.
Read the detailed description
Multiple myeloma is a malignant plasma cell disorder. Real-time dynamic monitoring of the development, progression, and treatment response of myeloma remains an unmet clinical need. The development of a novel non-invasive in vivo detection technique is essential and holds significant importance for improving the prognosis of myeloma patients. Nuclear medicine plays a crucial role in the diagnosis, staging, treatment, and follow-up of multiple myeloma. The commonly used clinical nuclear imaging method, 18F-FDG PET/CT, has certain limitations in detecting myeloma lesions. B-cell maturation antigen (BCMA) is a target that is highly and specifically expressed on the surface of myeloma cells. The 68Ga-labeled nanobody targeting BCMA demonstrates high specificity in detecting myeloma lesions. Compared to traditional antibody-based probes, it offers advantages such as a simpler structure, lower molecular weight, and higher stability, showing promise as a novel non-invasive molecular imaging technique for myeloma evaluation and guiding individualized treatment. Our research group has completed the preparation, labeling, and quality control of the 68Ga-NOTA-BCMA nanobody molecular probe, as well as preclinical studies on its pharmacokinetics, pharmacodynamics, and safety evaluation.In this prospective study, patients diagnosed with multiple myeloma were enrolled to undergo 68Ga-BCMA nanobody imaging before treatment, followed by a repeat scan after treatment, to analyze its detection rate and correlation with clinical tumor burden.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- 68Ga-BCMA nanobody PET/CT, 18F-FDG PET/CT
- Keywords
- Multiple Myeloma, PET/CT, BCMA
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-BCMA nanobody PET/CTDiagnostic test
On the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later.
18F-FDG PET/CTDiagnostic test
Within 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later.
| Study group | Role | What they receive |
|---|---|---|
| BCMA and FDG | Experimental | All enrolled patients will undergo both 68Ga-BCMA nanobody PET/CT imaging and 18F-FDG PET/CT imaging.On the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later. Within 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later. Receives: Diagnostic Test: 68Ga-BCMA nanobody PET/CT; Diagnostic Test: 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of 68Ga-BCMA nanobody PET/CT
The number of patients with positive BCMA PET results was counted and divided by the total number of individuals who completed BCMA PET imaging to calculate the detection rate of BCMA PET.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Survival
The time to progression (TTP) in follow-up patients was analyzed using the log-rank test for survival analysis to examine the association between baseline BCMA PET positivity and TTP.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaping Luo, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353554
- Sponsor's protocol ID
- BCMA-PET
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Study of 68Ga-NOTA-BCMA Nanoantibody Imaging in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07353554
- Acronym / sponsor ID
- BCMA-PET
- Conditions
- Multiple Myeloma (MM)
- Keywords
- Multiple Myeloma, PET/CT, BCMA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 20 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 study intends to employ 68Ga-NOTA-BCMA nanobody PET/CT imaging in patients with multiple myeloma to evaluate the feasibility of this technique for myeloma assessment, analyze the correlation between 68Ga-NOTA-BCMA nanobody uptake intensity and disease staging, tumor burden, and prognosis, explore its value in assessing treatment response and predicting early relapse, and compare its detection rate for myeloma lesions with that of 18F-FDG PET/CT. The results of this study may provide a more sensitive and specific imaging diagnostic method for patients with multiple myeloma and offer a basis for the individualized selection of future BCMA-targeted therapies. This study has been approved by the Ethics Committee of Peking Union Medical College Hospital.
Detailed description
Multiple myeloma is a malignant plasma cell disorder. Real-time dynamic monitoring of the development, progression, and treatment response of myeloma remains an unmet clinical need. The development of a novel non-invasive in vivo detection technique is essential and holds significant importance for improving the prognosis of myeloma patients. Nuclear medicine plays a crucial role in the diagnosis, staging, treatment, and follow-up of multiple myeloma. The commonly used clinical nuclear imaging method, 18F-FDG PET/CT, has certain limitations in detecting myeloma lesions. B-cell maturation antigen (BCMA) is a target that is highly and specifically expressed on the surface of myeloma cells. The 68Ga-labeled nanobody targeting BCMA demonstrates high specificity in detecting myeloma lesions. Compared to traditional antibody-based probes, it offers advantages such as a simpler structure, lower molecular weight, and higher stability, showing promise as a novel non-invasive molecular imaging technique for myeloma evaluation and guiding individualized treatment. Our research group has completed the preparation, labeling, and quality control of the 68Ga-NOTA-BCMA nanobody molecular probe, as well as preclinical studies on its pharmacokinetics, pharmacodynamics, and safety evaluation.In this prospective study, patients diagnosed with multiple myeloma were enrolled to undergo 68Ga-BCMA nanobody imaging before treatment, followed by a repeat scan after treatment, to analyze its detection rate and correlation with clinical tumor burden.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA and FDG | Experimental | Diagnostic Test: 68Ga-BCMA nanobody PET/CT, Diagnostic Test: 18F-FDG PET/CTAll enrolled patients will undergo both 68Ga-BCMA nanobody PET/CT imaging and 18F-FDG PET/CT imaging.On the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later. Within 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed or relapsed MM patients
- Written informed consent obtained and capable of undergoing follow-up.
Key exclusion criteria (6 listed)
- Severely abnormal liver and kidney function
- Women who are planning pregnancy, are pregnant, or are breastfeeding, as well as those with childcare plans during the study period; subjects of childbearing potential must use effective contraceptive measures throughout the study.
- Individuals unable to lie flat for 30 minutes.
- Individuals who decline to participate in this clinical study.
- Patients with claustrophobia or other psychiatric disorders, or poor compliance that may compromise their ability to cooperate with the study procedures.
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 nanobody PET/CTOn the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later. | Diagnostic test | BCMA and FDG |
| 18F-FDG PET/CTWithin 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later. | Diagnostic test | BCMA and FDG |
Primary outcome
Detection rate of 68Ga-BCMA nanobody PET/CT
Time frame: through study completion, an average of 1 year
The number of patients with positive BCMA PET results was counted and divided by the total number of individuals who completed BCMA PET imaging to calculate the detection rate of BCMA PET.
1 secondary outcome
Survival
Time frame: through study completion, an average of 1 year
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 20 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Yaping Luo principal investigator
Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-BCMA nanobody PET/CT and 18F-FDG PET/CT in people with Multiple Myeloma (MM), run by Peking Union Medical College Hospital at 1 site 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Yaping Luo (010-69154716, luoyaping@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of 68Ga-BCMA nanobody PET/CT (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.