Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the diagnosis criteria; 2. MM that is refractory to standard of care or relapsed from response; 3. Age >=18 years; 4. Karnofsky Performance Status Score >=60; 5. Life expectancy >=3 months; 6. No prior chemotherapy, radiotherapy, target therapy, angiogenesis inhibitor or interferon within the last 2 weeks; 7. No significant major organ disorder and laboratory tests meeting the following: Hematology: WBC>=2.0*10^9/L, neutrophil>=1.5*10^9/L, Platelet count>=30*10^9/L, hemoglobin>=60g/L; Liver function: serum total bilirubin, ALT and AST10ml/min; 8. Signed Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Prior history of hypersensitivity to biological products including protein or allergic constitution; 3.Prior history of viral hepatitis or other liver diseases; 4.Present orA history of mental disorder; 5. Serious or uncontrolled disorder of major organs (cardiovascular, respiratory, gastrointestinal, neurologic, etc.) within 6 months prior to enrollment, including cardiac infarction, Grade III-IV heart failure, angina, heart disease with significant clinical manifestations, left ventricular ejection fraction <0.5, serious conduction dysfunction; or hypotension (sitting SBP<=90mmHg or sitting DBP<=60mmHg.); 6. Other types of tumor; 7. Other conditions that in the investigator’s opinion preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;AE; | — |
Countries
China
Contacts
Beijing Chaoyang Hostipital