Multiple Myeloma
Conditions
Interventions
younger than 65 years patients with more than 75% PR post-induction:bortezomib based maintenance therapy
younger than 65 years patients with less than 75% PR post-induction:lenalidomide based maintenance therapy
younger than 65 years patients post-induction:bortezomib and lenalidomide combined treatment
older than 65 years patients with less than 75%PR post-induction:bortezomib and lenalidomide combined treatment
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. newly diagnosed symptomatic MM with measurable disease: (1) age of at least 18 years, male and female; (2) fulfill the criteria for MM diagnosis; (3) present at least one of the CRAB symptoms. 2. ECOG performance status smaller than 2 and a life expectancy of more than 2 months; 3. measurable paraprotein in serum more than 10g/L or urine more than 200mg/24h; 4. no active infectious disease; no severe organ failure (except renal failure secondary to MM); 5. baseline parameters within 14 days of enrollment: platelet count more than 50*10^9/L; heart rate more than 50 bpm; total bilirubin less than 1.5 ULN; AST and ALT less than 2.5 ULN; no recent ischemic cardiac event (unstable angina, myocardial infarction within 6 months of enrollment); 6) capable of taking medicine per os; 7) all screening procedures and evaluations should be completed; 8) all patients should provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. allergy to borate; 2. severe impaired liver function; HIV positive or had active hepatitis A, B or C infection; HBV-DNA more than 10^4/L; AST and ALT more than 2.5 ULN; 3. at least grade 2 peripheral neuropathy with or without pain prior to treatment; 4. any disease that could put patients at high risk, including but not limited to unstable cardiac disease, defined as myocardial infarction in the previous 6 months, NYHA class III-IV heart failure, uncontrolled atrial fibrillation or hypertension; conditions requiring longterm steroids or immunosuppressive drugs; 5. renal failure requiring hemodialysis or peritoneal dialysis; 6. severe prior thrombosis-event; 7. major surgery within 30 days of enrollment; 8. history of other malignancy, unless cured for more than 3 years; 9. pregnancy, lactation or disagreement to take contraceptive measures; 10. severe infectious disease (uncured tuberculosis, pulmonary aspergillosis); 11. epilepsia, dementia or any mental disease requiring treatment; 12. any drug abuse, medical, pychiatric or social condition that could interfere with the results or evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR;VGPR;PR;time to progression, TTP;progression-free survival, PFS;overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival, DFS; | — |
Countries
China
Contacts
Public ContactJIANQING MI
Outcome results
None listed