Overview

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.