Multiple Myeloma and plasma cell leukemia
Conditions
Interventions
Treatment group:CAR-T Cell Therapy
Sponsors
Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Accordance to the internationally accepted criteria for the diagnosis of multiple myeloma and plasma cell leukemia; 2. BCMA positive expression detected by flow cytometer or immunohistochemical in patients with refractory multiple myeloma and plasma cell leukemia; 3. Aged 18-75 years; 4. Be diagnosed of MM/PCL and according to the following criteria: 1) monoclonal plasma cells in the bone marrow =10%, or plasmacytoma confirmed by biopsy; 2) Disease is measurable during screening, which according to the following definitions: IgG type: serum monoclonal paraprotein (M protein) level = 1.0 g / dL, or urinary M protein level =200 mg / 24 h; IgA, IgD, IgE or IgM type: Serum M protein level =0.5 g / dL, or urinary M protein level =200 mg / 24 h; light chain type if there is no measurable lesion in the serum or urine: abnormal chain serum immunoglobulin FLC = 10 mg / dL and serum immunoglobulin ? / ? FLC ratio abnormalities; abnormal plasma cells = 20%, or absolute = 2 × 10^9/L in peripheral white blood cell classification; with extracorporeal plasmacytoma diameter greater than 1cm; 5. Have received at least 3 lines of treatment; 6. Scored 0,1 or 2 by ECOG physical status; 7. Screening period Clinical laboratory examination values meet the following criteria: Hemoglobin = 60 g/L; Absolute neutrophil count (ANC) = 2.0 x 10^9/L (G-CSF was allowed to be uesd); Blood platelet count= 50x 10^9/L; Aspartate aminotransferase (AST) = 2.5 x upper limit (ULN); alanine aminotransferase (ALT) = 2.5 x ULN; total bilirubin= 2x ULN, direct bilirubin =2 x ULN except for congenital bilirubinemia (eg, Gilbert syndrome); Creatinine clearance = 30 mL / min 1.73 m2; Corrected serum calcium = 14 mg/dL (= 3.5 mmol/L); or free calcium = 6.5 mg/dL (= 1.6 mmol/L); 8. An informed consent form (ICF) will be signed by the applicant's or his / her legal representative indicating that he has understood the purpose and procedures required for the study and is willing to participate in the study; 9. Before randomization, female subjects must meet the following conditions: have no fertility or using effective contraceptive measures; 10. Expected survival time:> 3 months; 11. Willing to observe the adverse events and efficacy; 12. No other anti-tumor treatment (including steroid drugs).
Exclusion criteria
Exclusion criteria: 1. pregnant or lactating women; 2. uncontrolled infectious diseases: e.g. HIV, hepatitis B, hepatitis C and other deadly diseases of viral or bacterial infections; 3. usage of systemic steroids (Prednisone p.o. 5mg/day or more) in last 2 weeks; 4. other uncontrolled diseases that may lead to death; serious anaphylases to any drugs; 5. patients who need to take immunosuppressive agents to control GHVD after allogeneic stem cell transplantation in the last 6 months; 6. patients with acute autoimmune diseases such as psoriasis, rheumatoid arthritis, etc.; 7. occurrence of myocardial infarction, Grade III or IV heart failure by New York heart Association (NYHA), uncontrollable angina pectoris, severe ventricular arrhythmias, or acute ischemia or clinically significant conduction system abnormalities on electrocardiogram in the last 6 months; 8. Central nervous system metastasis or infection (including cranial neuropathy, occupying or spinal cord compression), or with uncontrollable infection; 9. Infectious fever with temperature above 38 degree C or clinical conditions affect the study; 10. uncontrolled hypertension by drugs (systolic blood pressure exceeds 160 mmHg or the diastolic pressure exceeds 100mmHg); 11. other instances excluded by the clinicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Duration Of Response;Time To Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactLijuan Chen
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Outcome results
None listed