Multiple Myeloma
Conditions
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
Interventions
DRUGMelphalan
powder for injection, 200mg/m2, uses after reconstituted within 24 hours
Sponsors
Shandong Lanjin Pharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed