Relapse or refractory multiple myeloma
Conditions
Interventions
Group 1:BCMA and CD38 CAR-T cell therapy
Group 2:BCMA CAR-T cell therapy
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient or his/her legal guardians must sign a consent form; 2. The patient ages 6 years to 60 years, male or female; 3. By cell morphology and flow cytometry analysis examination diagnosis of patients with multiple myeloma, poor curative effect after standard treatment scheme, a diagnosis of recurrence of refractory multiple myeloma; 4. The patient has lesions which can be measured or evaluated; 5. Main organs seem to be functioning well: Liver function: bilirubin=34.2umol/L; Renal function: Serum creatinine<220umol/L; Lung function: arterial oxygen saturation=95%; Heart function: LVEF=40%; 6. Peripheral venous blood in patients flow smoothly; 7. Karnofsky score=60.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients who want to be pregnant in 1 year; 3. Patients who can not use contraception in 1 year; 4. Uncontrolled active infection with in 4 weeks; 5. Active hepatitis B or hepatitis C virus infection; 6. HIV infected patients; 7. Patients with other cancers diagnosised by pathology; 8. Patients with serious autoimmune diseases or immunodeficiency; 9. Patients who suffer from allergies; 10. Patients who have taken part in other clinical tests within 6 weeks; 11. Patients who use systemic steroids before treatment within 4 weeks; 12. Patients who have a history of central nervous system disease; 13. Patients who are addicted to some drugs; 14. Patients who are not allowed to take part in the test(judged by the researchers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ;M protein detected by Fixed electrophoresis; | — |
Countries
China
Contacts
Public ContactDeng Qi
Tiajin First Central Hospital
Outcome results
None listed