Multiple Myeloma (MM)NCT06925958
A Clinical Trial Evaluating the Safety Tolerability, Radiation Absorption Dose, Distribution, PET Imaging and Histological Expression of 68Ga-NOTA-SCH001 in Patients With Multiple Myeloma
A study testing Flow cytometry in people with Multiple Myeloma (MM), run by The First Affiliated Hospital of Soochow University.
Trial summary
Multiple myeloma is the second most common hematologic malignancy in adults, and no curative treatment currently exists. With the development of monoclonal antibodies for tumor therapy, identifying tumor-specific biomarkers has become a prerequisite for pre- and post-treatment evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- Flow cytometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
- 2. Over 18 years old, male or female;
- 3. Patients diagnosed with multiple myeloma;
- 4. ECOG score is 0-1; The expected survival time is not less than 3 months;
- 5. Women of childbearing age need to undergo urine pregnancy test, and enrolled patients must be negative for pregnancy test;
- 6. For fertile female patients or male patients with fertile partners, agree to remain abstinent during the study period (no
- Or use one or more contraceptive methods with a failure rate of less than 1% per year for at least one year after the end of the study.
- 7. CD38 monoclonal antibody therapy was not used before enrollment in this study.
Who cannot join
- General situation
- Those who are unable to perform visits, or receive relevant tests, or treatment in accordance with the clinical trial protocol;
- Can not tolerate venous puncture blood collection;
- Patients with serious diseases or other malignant tumors, except those that the researchers determined to be in stable control;
- Known severe allergy to SCH001, similar drugs or excipients;
- Laboratory examination
Show all 16Show fewer
- Serum virology test: any of the results of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis specific antibodies
- Positive or HIV-negative antibodies cannot be determined;
- Fasting blood glucose >11.1mmol/L;
- other
- No active infection
- Drug/alcohol abuse, severe mental disorders;
- Patients with claustrophobia, emotional instability, acute persistent spasms, or inability to keep their arms up and lie flat for 30 minutes;
- Participants in any other clinical trial within 3 months prior to screening;
- Women who are pregnant or breastfeeding;
- The investigator did not consider it appropriate to participate in this clinical study.
About this study
Multiple myeloma is the second most common hematologic malignancy in adults, and no curative treatment currently exists. With the development of monoclonal antibodies for tumor therapy, identifying tumor-specific biomarkers has become a prerequisite for pre- and post-treatment evaluation. CD38, which is abnormally elevated in 95% to 100% of malignant plasma cells but relatively low in normal cells, serves as a biomarker for multiple myeloma. In clinical practice, CD38 expression is typically detected through flow cytometry and microscopic examination of bone marrow biopsy samples. However, biopsies are invasive and prone to false-negative results in cases of heterogeneity or small lesion samples, whereas whole-body imaging methods allow non-invasive assessment of target expression.
[¹⁸F]FDG PET/CT imaging is one of the most commonly used techniques in multiple myeloma. However, its diagnostic application is limited by false-negative results due to low hexokinase 2 expression in myeloma cells. Additionally, it fails to provide accurate molecular information, such as CD38 expression in cells. Therefore, this study aims to develop a more specific and stable molecular imaging probe, ⁶⁸Ga-NOTA-SCH001, to non-invasively visualize CD38 expression and monitor responses to CD38-targeted therapy in real time. This approach may also contribute to the formulation and optimization of clinical treatment strategies.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- Flow cytometry
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometryDiagnostic test
CD38 Flow cytometry testing
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NOTA-SCH001 PET/CT imaging | Experimental | Not described Receives: Diagnostic Test: Flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/CT imaging SUV value
Measured: 0-30minutes、60minutes、120minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 The First Affiliated Hospital of Soochow UniversityThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925958
- Sponsor's protocol ID
- 2024-MI- 68Ga-NOTA-SCH001-34
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Evaluating the Safety Tolerability, Radiation Absorption Dose, Distribution, PET Imaging and Histological Expression of 68Ga-NOTA-SCH001 in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06925958
- Acronym / sponsor ID
- 2024-MI- 68Ga-NOTA-SCH001-34
- Conditions
- Multiple Myeloma (MM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Apr 2025 (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.
Multiple myeloma is the second most common hematologic malignancy in adults, and no curative treatment currently exists. With the development of monoclonal antibodies for tumor therapy, identifying tumor-specific biomarkers has become a prerequisite for pre- and post-treatment evaluation. CD38, which is abnormally elevated in 95% to 100% of malignant plasma cells but relatively low in normal cells, serves as a biomarker for multiple myeloma. In clinical practice, CD38 expression is typically detected through flow cytometry and microscopic examination of bone marrow biopsy samples. However, biopsies are invasive and prone to false-negative results in cases of heterogeneity or small lesion samples, whereas whole-body imaging methods allow non-invasive assessment of target expression.
[¹⁸F]FDG PET/CT imaging is one of the most commonly used techniques in multiple myeloma. However, its diagnostic application is limited by false-negative results due to low hexokinase 2 expression in myeloma cells. Additionally, it fails to provide accurate molecular information, such as CD38 expression in cells. Therefore, this study aims to develop a more specific and stable molecular imaging probe, ⁶⁸Ga-NOTA-SCH001, to non-invasively visualize CD38 expression and monitor responses to CD38-targeted therapy in real time. This approach may also contribute to the formulation and optimization of clinical treatment strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NOTA-SCH001 PET/CT imaging | Experimental | Diagnostic Test: Flow cytometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
- 2. Over 18 years old, male or female;
- 3. Patients diagnosed with multiple myeloma;
- 4. ECOG score is 0-1; The expected survival time is not less than 3 months;
- 5. Women of childbearing age need to undergo urine pregnancy test, and enrolled patients must be negative for pregnancy test;
Key exclusion criteria (16 listed)
- General situation
- Laboratory examination
- Serum virology test: any of the results of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis specific antibodies
- Positive or HIV-negative antibodies cannot be determined;
- Fasting blood glucose >11.1mmol/L;
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 |
|---|---|---|
| Flow cytometryCD38 Flow cytometry testing | Diagnostic test | 68Ga-NOTA-SCH001 PET/CT imaging |
Primary outcome
PET/CT imaging SUV value
Time frame: 0-30minutes、60minutes、120minutes
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 13 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flow cytometry in people with Multiple Myeloma (MM), run by The First Affiliated Hospital of Soochow University.
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 8 inclusion and 16 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET/CT imaging SUV value (time frame: 0-30minutes、60minutes、120minutes). 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 13 Apr 2025.