Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Alone Group:CPT+Thal
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. Meet all of the following: 1) relapsed after at least two cycles of first line chemotherapy, or progressed after or refractory to the last therapy (at least 2 cycles); 2) at least one of the latest therapeutic regimens (within 3 months) were based on thalidomide or other maintenance treatment (the dose of thalidomide not lower than 100mg/d); 3. Aged >=18 years; 4. Karnofsky Performance Status Score >=60; 5. Life expectancy >=3 months; 6. No prior chemotherapy or radiotherapy other than thalidomide within the last 4 weeks; 7. No significant organ disorder (at least Grade I toxicity, unless specified below) and laboratory tests meeting the following: Hematology: WBC>=3.0*10^9/L, neutrophil>=1.0*10^9/L, platelet count>=30*10^9/L, hemoglobin>=60g/LLiver function: serum total bilirubin, ALT and AST within normal rangesRenal function: CrCl>=30ml/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 or history of mental disorder; 5. Serious or uncontrolled disorder of major organs within 12 months prior to enrollment; history of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, active bleeding or de novo thrombus, concurrent use of anticoagulant, or history of hemorrhagic tendency 6. History of other tumors (with the exception of basal cell carcinoma or squamous cell carcinoma of the skin that achieved CR, or history of carcinoma in situ of the cervix or breast); 7. Serious infection or serious dysbolism; 8. Concomitant use of any drug label-indicated for tumor (including TMC and immunomodulators, etc); 9. Prior intolerance to thalidomide dose>=100mg/d; 10. Non-secretory MM (M-protein or free light chain not measurable); 11. Other conditions that in the investigator’s opinion preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;OR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DOR; | — |
Countries
China
Contacts
Public ContactWenming Chen
CCMU Beijing Chaoyang Hostipital
Outcome results
None listed