Multiple meyloma
Conditions
Interventions
bendamustine and melphalan group:bendamustine and melphalan
melphalan group:melphalan alone
Sponsors
Department of Hematology and oncology, Cancer Hospital Affiliated to Chongqing University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects aged from 18 to 75 were male and female; 2. Patients with multiple myeloma who received induction therapy and prepared for autologous stem cell transplantation, including untreated and relapsed refractory patients; 3. Subjects with ECoG <= 2; 4. Subjects with an expected survival of more than 3 months; 5. For TBIL <= 2.0mg/dl, AST and alt <= 3.0 x ULN; 6. Subjects who have signed informed consent. Informed consent was signed by the patient or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family members should sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergy to bendamustine, melphalan or their excipients; 2. Patients with other tumors or previous tumor history at the same time; 3. Known patients with hepatitis B virus or hepatitis C virus (HCV) activity, or human immunodeficiency virus (HIV) serological positive; 4. Patients with uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before enrollment, grade III - IV heart failure defined by New York Heart Association (NYHA), uncontrolled angina pectoris, congestive heart failure, clinically significant pericardial disease or cardiac amyloidosis (NT Pro BNP >= 1800pg / ml); 5. Patients with severe infectious diseases at the same time; 6. According to the protocol or the judgment of the researcher, patients with severe physical or mental diseases may interfere with the participation in this clinical study; Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the results of the study; 7. Patients receiving other experimental drugs; 8. Pregnant or lactating women; 9. Subjects considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal residual disease negative rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival rate;Overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactYao Liu
Cancer Hospital Affiliated to Chongqing University
Outcome results
None listed