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

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Treatments: Melphalan

Criteria

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.