Multiple myeloma
Conditions
Interventions
Test group:Daretozumab + bortezomib + lenolidomide + dexamethasone
Sponsors
The first affiliated hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with first recurrent MM according to IMWG diagnostic criteria 2) Age 50-80 3) WBC = 4.0 * 10E9/L, Hb = 75g/L, PLT = 75 * 10e9/L 4) When selected, the ECOG score is 0-2 Liver and kidney function: blood bilirubin = 2mg/dL (35 µ Mol/L), AST/ALT below 2 times the upper limit of normal value, blood creatinine normal or creatinine clearance rate (Ccr) = 30ml/min, calculation formula: Male: creatinine clearance rate=[(140 age) × Weight (kg)]/[0.818 × Blood creatinine concentration( µ Mol/L), or creatinine clearance rate=[(140 age) × Body weight (kg)]/[72 × Blood creatinine concentration (mg/dl); The calculation results for women based on the above formula × 0.85. 5) Normal cardiac function: EF>50% 6) Expected survival time = 3 months 7) Obtaining informed consent signed by the patient or family member
Exclusion criteria
Exclusion criteria: 1) Have a history of other malignant tumors within the past 5 years 2) HIV positive, active tuberculosis, clinically active hepatitis A, B, and C patients; 3) Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes, severe cardiac insufficiency or angina) 4) General condition not suitable for chemotherapy 5) Pregnant or lactating women 6) Combined with other serious organic diseases and Mental disorder; 7) Unable to understand or follow the research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4 course complete remission (CR) rate;negative MRD rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;safety; | — |
Countries
China
Contacts
Public ContactHaitao Meng;Hongyan Tong
The first affiliated hospital of Zhejiang University
Outcome results
None listed