Multiple myeloma
Conditions
Interventions
Experimental group:Lenalidomide 25mg / d oral, days 6-26
bortezomib 1.3mg / m2, subcutaneous injection, administration on days 6, 9, 13, 16
dexamethasone 20mg / d, oral, days 6, 9, 13 and 16 days of administration
Decitabine, administered on days 1-5, 5-7.5mg / m2, 33 days as a course of treatment, a total.
Control group:Lenalidomide 25mg / d orally, day 1 ~ 21
bortezomib 1.3mg / m2, subcutaneous injection, administration on days 1, 4, 8, 11
dexamethasone 20mg / d, oral, day 1, 4, 8 and 11 days of administration
28 days is a course of treatment, a total of 8 courses of treatment.
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients willing to sign informed consent; 2. Patients over 18 years old; 3. The patients who were diagnosed as multiple myeloma by cell morphology and flow cytometry were not effective after receiving the standard treatment plan. The patients who were diagnosed as relapsed refractory multiple myeloma and relapsed for the first time; 4. At the screening stage, the M protein of myeloma lesions (obtained by serum / urine protein electrophoresis) can be measured, which must meet at least one of the following test indicators: Serum M protein >=10g / L (protein electrophoresis) or IgA >=7.5g/l (turbidimetric immunoglobulin quantification); urine M protein >=0.2g/24h. 5. Patients with ECoG score =1.0x10^9/L; platelet (PLT) >=50x10^9/L; AST / SGOT =30ml/min.
Exclusion criteria
Exclusion criteria: 1. The recipient of stem cell transplantation, manifested as graft-versus-host disease, was active or needed immunosuppressive treatment when signing the informed consent; 2. Patients who have a history of allergic reaction or use contraindications to any of the drug ingredients in this trial; 3. Patients who have received any conventional or research anti multiple myeloma drug treatment within 4 weeks (the instructions indicate that it is used for anti multiple myeloma treatment; thalidomide maintenance treatment is shortened to 2 weeks before the test) or radiotherapy (if they have received restricted field radiotherapy, the time can be shortened to 2 weeks before the test); 4. Patients who have undergone major surgery within 2 weeks; 5. Patients with plasmacytic leukemia; 6. Patients with other malignant tumors; Seven Patients with poorly controlled hypertension or clinically significant (e.g. active) cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months prior to signing the informed consent), unstable angina, congestive heart failure classified as level II or above by the New York Heart Association, or severe arrhythmia control failure Good or has a potential impact on the study treatment; 8. Patients with other serious organic diseases and mental disorders; 9. Patients with systemic active infection requiring treatment; 10. Known HIV positive patients or patients with clinically active hepatitis A, B and C; 11. Pregnant or nursing women; 12. Dementia, mental disorder, or any mental illness that hinders the understanding of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS; | — |
Countries
China
Contacts
Public ContactFang Baijun
He'nan Cancer Hospital
Outcome results
None listed