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

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

Official Title
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A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Melphalan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous stem cell transplant<br> | Drug: Melphalan<br>* powder for injection, 200mg/m2, uses after reconstituted within 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year Progression Free Survival | Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment | 20 months |