Multiple Myeloma(MM)
Conditions
Interventions
Patients with Multiple Myeloma(MM):RN1201 Injection
Sponsors
The First Affiliated Hospital of Soochow University, Suzhou, China
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this trial and sign the informed consent form; 2. Diagnosed with multiple myeloma (MM) according to the World Health Organization (WHO) 2017 revised version; 3. The type of multiple myeloma recorded at the screening visit or with previous medical records is BCMA positive; 4. Age>=18, =12 weeks; 6. The serum total bilirubin level is less than twice the upper limit of normal, the serum creatinine level is lower than the upper limit of normal, and the blood alanine aminotransferase and aspartate aminotransferase are less than 3 times the upper limit of the normal range; 7. ECOG score 0-2 points; 8. Left ventricular ejection fraction (LVEF) >=50% and no pericardial effusion; 9. Able to comply with the study visit schedule and other protocol requirements. "
Exclusion criteria
Exclusion criteria: 1. Patients with severe active infection; 2. Subjects with acquired and congenital immunodeficiency diseases; 3. Subjects with cardiac insufficiency of grade III. or IV according to the New York Heart Association (NYHA) cardiac function grading criteria; 4. Subjects with a history of epilepsy or other central nervous system diseases; 5. Subject has a history of other primary cancers, with the following exceptions: a. Non-melanoma cured by excision, such as basal cell carcinoma of the skin b. Cured carcinoma in situ such as cervical, bladder or breast cancer 6. Those who have used high-dose steroids in the past 2 weeks before treatment; 7. Female subjects who are pregnant, lactating, or have a pregnancy plan within 6 months; 8. Those who have participated in other clinical trials within one month; 9. Major surgical procedure within 14 days prior to the first dose of study drug. 10. Any condition that, in the opinion of the investigator, may increase the risk of the subject or interfere with the results of the trial. "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum M protein;Bone marrow plasma cell percentage; | — |
Countries
China
Contacts
Public ContactXiaowen Tang
The First Affiliated Hospital of Soochow University, Suzhou, China
Outcome results
None listed