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

Shandong Lanjin Pharmaceuticals

Status

Unknown

Conditions

Multiple Myeloma

Treatments

Drug: Melphalan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01572688

RG0276

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.