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

Not Applicable

• Conditions: Multiple Myeloma
• Interventions: Drug: Melphalan

• Registration Number: NCT01572688
• Lead Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous stem cell transplant	Melphalan	-

Primary Outcome Measures

Name	Time	Method
1 year Progression Free Survival	20 months	Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment

Trial Locations

Locations (1)

Hematologic Hospital of Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China