Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Sponsors
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Must meet the diagnostic criteria for multiple myeloma as defined by the IMWG(2017); 2. Relapsed or refractory patients who have received at least two courses of treatment, and progressed or relapsed after the last treatment; 3. Detection of bone marrow or plasmacytoma by flow cytometry or immunohistochemistry shows BCMA and/or CD38 expression on more than 50% of malignant plasma cells; 4. The disease can be measured at screening, and it meets any of the following definitions: 1) Abnormal serum monoclonal protein (M protein) = 1.0g/dL; 2) Urine M protein =200mg/24h; 3) Serum involvement FLC=10mg/dL and abnormal serum ?/? FLC ratio; 5. The toxicity of previous treatment must be stable and restored to = grade 1 (except for non-clinical toxicity, such as hair loss); 6. ECOG scored 0 to 2 points (except for bone pain caused by tumors); 7. Absolute neutrophil count = 1×10^9/L; 8. Platelet count = 50×10^9/L; 9. Absolute lymphocyte count =100/µL; 10. Hemoglobin = 8.0g/dL; 11. Good functions of kidney, liver, lungs and heart; 12. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit; 13. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Autologous or allogeneic stem cell transplantation was performed within 3 months prior to enrollment; 2. Asymptomatic myeloma (smouldering multiple myeloma); 3. Previously received BCMA or CD38 targeted cell therapy; 4. Previously received chimeric antigen receptor therapy or other lentiviral-mediated transgenic therapy; 5. There are uncontrollable fungi, bacteria, viruses or other infections; 6. Subjects requiring treatment with systemic corticosteroids (prednisone =5 mg/day, or equivalent doses of other corticosteroids) or other immunosuppressive drugs during the study, including treatment with MM (except for the treatment of adverse events); 7. Patients with active hepatitis B or hepatitis C virus infection, or HIV-infection; 8. With a history of epilepsy or other central nervous system diseases; 9. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System); 10. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| white blood cell;platlet;hemoglobin;interferon-?;tumor necrosis factor-a;interleukin-6;interleukin-10;interleukin-2;C reactive protein;chimeric antigen receptor T-cell; | — |
Countries
China
Contacts
Public ContactYu Hu
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed