A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma
- Patients with greater or equal to 18 years, with a upper age limit of 65 years are
- Multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of
- Patients with responsive disease after induction therapy not more than 6 courses of
- A complete response
- A very good partial response
- A partial response
- At least 4 weeks long from last cytotoxic treatment(exclude Bortezomib, thalidomide,
- Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 Patient has an absolute
neutrophil count of ≥1.5×109/L and platelet count≥80×109/L;
- Calculated creatinine clearance ＞50ml/min by Cockcroft-Gault formula or collect urine
within 24 hours.
- Patient with a total bilirubin ≤1.5 times of normal upper limit, AST,ALT≤2.5times of
normal upper limit;
- Cardio-pulmonary function is adequate to conduct autologous stem cell transplant.
- Ratio of body weight and ideal body weight ＜175%;
- All patients should have a life expectancy of more than 12 weeks
- Signed informed consent form voluntarily
- CD34 positive hematopoietic stem cell collected ＜2.0×106/kg
- Patients have a psychiatric history
- Female subject is pregnant or breast-feeding
- Patients are hypersensitive to this trial product or other alkylating agents
- Participate of other clinical trials within the past 4 weeks Active CNS lesions
- Concomitant of active infection or positive of HIV antibody
- Concomitant of other un-healed malignancy
- Left ventricular ejection fraction≤50%
- Patients with serious thrombosis
- Any severe concomitant disease that will expose study subjects to unacceptable risks.
- Patients not suitable to enroll by investigators considerations.