Multiple myeloma
Conditions
Interventions
experimental group:VTD regimen combined with arsenic trioxide
control group:VTD regimen
Sponsors
Hematology department of Huadong hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed as multiple myeloma and have not been treated before; 2. 18-80 years old; 3. ECoG score 60%, no arrhythmia or unstable rhythm; 5. serum bilirubin < 2 x normal upper limit, serum GPT < 2 x normal upper limit; those patients who have no chronic active hepatitis or cirrhosis and whose renal function is below ckd4 stage; 6. Patients with negative pregnancy test. For women with fertility potential, the consent of themselves and their families shall be obtained. 7. Patients who sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with grade 4 hematological adverse reactions during the treatment; 2. Patients with end-stage heart failure found by LV assist device, intra aortic balloon pump (IABP) or any kind of detection means during the treatment, who need coronary revascularization, electrophysiological device implantation, cardiac mechanical support implantation or other cardiac operations due to their condition; 3. Patients with serious diseases or short life expectancy that make it difficult to implement the program or explain the results of the study (cardiovascular diseases include New York Heart Association grade IV, congestive heart failure, respiration, liver, nervous system including stroke, psychosis or active malignant tumor in the treatment process: skin cancer other than melanoma is not excluded, or other major diseases Systemic diseases); 4. Any other actual or expected situation (such as regional and social) that may lead to restrictions on patients' participation in the study, according to the researcher; 5. Any specific laws and regulations of any country that prevent patients from entering the study (for example, restrictions formed by decisions of judicial departments or instructions of administrative organs); 6. Women of childbearing age who are unwilling to take effective contraceptive measures during the study and follow-up period or who are unwilling or unable to accept pregnancy examination during the study; 7. Patients with disease progression during follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| M protein;progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to progress, TTP;objective response rate, ORR;overall survival, ORR;Adverse events; | — |
Countries
China
Contacts
Public ContactChen Pingping
Huadong Hospital
Outcome results
None listed