Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Multiple Myeloma (MM)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- • 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06925958
Start Date
May 1 2025
End Date
December 31 2026
Last Update
April 13 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.