Refractory and relapsed multiple myeloma
Conditions
Interventions
Sponsors
Chinese People's Liberation Army (PLA) General Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 14 years old or above 2. Multiple myeloma (MM) that has been diagnosed in the hospital has been treated with multiple first-line clinical treatments, has become resistant to current treatments, and has a predicted survival period of more than three months. 3. Myeloma cells were BCMA positive by flow cytometry. 4. The hospital inspection meets the following indicators: a.ECOG physical status score 0-2 or KPS score >80 points b. Have sufficient venous access for apheresis or venous blood collection, and have no other contraindications to blood cell separation c.WBC=1×109/L, LY=0.3×109/L, d. ALT and AST=2.5 ULN e. Serum total bilirubin =2.0mg/dL (34.2µmol/L) f. PT: INR<1.7 or PT is longer than normal value<4s
Exclusion criteria
Exclusion criteria: 1. After testing by the researcher, the patient’s myeloma sample was negative for BCMA. 2. Pregnant or breastfeeding women (the safety of this treatment on unborn babies is unknown, and the pregnancy status of female participants is assessed by a negative serum or urine pregnancy test within 48 hours before infusion) 3. Presence of active hepatitis B or hepatitis C virus infection 4. HIV/AIDS infection 5. Any uncontrollable active infection 6. Current use of systemic steroid drugs. People who have recently or currently used inhaled steroids are not excluded 7. Allergy to immunotherapy and related drugs 8. Patients who currently have heart disease or poorly controlled hypertension that require treatment 9. Patients with current unstable or active ulcers or gastrointestinal bleeding 10. Patients with a history of organ transplantation or who are waiting for organ transplantation 11. Hyponatremia, serum sodium 300 mg/d; clopidogrel, dose >75 mg/d) 15. Patients with neurological diseases, etc. Moreover 1) Patients who are participating in other clinical trials; 2) The researcher believes that the subject is not suitable for clinical trials for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Complete Response Rate;Partial Response Rate;Adverse Event Incidence Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactMeng Li
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed