Safety and Efficacy Study of High Dose Melphalan to Treat Multiple Myeloma (MM)

This is an interventional treatment trial for Multiple Myeloma Read More

Inclusion Criteria:

• Patients with greater or equal to 18 years, with a upper age limit of 65 years are eligible.
• Multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of IMWG2003/WHO2008 criteria.
• Patients with responsive disease after induction therapy not more than 6 courses of treatment
• A complete response
• A very good partial response
• A partial response
• At least 4 weeks long from last cytotoxic treatment(exclude Bortezomib, thalidomide, dexamethasone);
• 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

Exclusion Criteria:

• 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.