NCT01572688UnknownNot Applicable
A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma
Shandong Lanjin Pharmaceuticals Co.,Ltd1 site in 1 country60 target enrollmentStarted: November 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1 year Progression Free Survival
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
autologous stem cell transplant
Experimental
Intervention: Melphalan (Drug)
Outcomes
Primary Outcomes
1 year Progression Free Survival
Time Frame: 20 months
Plan to enroll all trial subjects within 8 months and follow up 1 year for each subject after enrollment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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