Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Sponsors
CCMU Beijing Chaoyang Hostipital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnosis criteria of MM; 2. Assessment of progressive disease by NCCN criteria after prior treatment; 3. Age>=18 years; 4. Karnofsky Performance Status Score >=70; 5. Life expectancy >=3 months; 6. Prior chemotherapy, radiotherapy, target therapy, angiogenesis inhibitors, interferon or other treatment for MM must have stopped for more than 4 weeks (2 weeks for thalidomide); 7. Normal cardiac and renal function and laboratory tests meeting the following: WBC>=3.0*10^9 /LPlatelet count >=50*10^9/L, Hemoglobin>=80g/L; AST/ALT=60ml/min, Total bilirubin within normal range; 8. Signed Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or women of childbearing potential who cannot take effective contraceptive measures during the study; 2. Prior history of hypersensitivity, especially to the ingredients of the study drug (CPT protein, mannitol, dibasic sodium phosphate or sodium biphosphate); 3. Chronic liver condition requiring medical intervention at enrollment; HBsAg, HBcAb (IgG or IgM) and E Antibody positive (simple HBsAb positive is eligible); 4. Mental disorder; 5. Other conditions contraindicated for the study drug or the high-risk factors for treatment complications; 6. Other types of tumor; Inability to describe treatment response; 7. Active infection or other serious underlying condition, HIV positive; 8. Participation in a clinical study of other investigation product within the last 4 weeks; 9. Poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK;AE;ORR; | — |
Contacts
Public ContactChen Wenming
Outcome results
None listed