Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT06925958
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06925958
Study Brief:
Protocol Section:
NCT06925958