primary systemic amyloidosis (AL)
Conditions
Interventions
the first group: the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD)
the second group:the combination regimen of bortezomib +thalidomide + dexamethasone (BTD)
Sponsors
People's Hospital, Beijing University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged between 18 and 75, men and women not limited; 2. Identification of AL amyloidosis by biopsy, always did not receive chemotherapy; 3. measurable abnormal serum and/or urine M proteins or free light chain (dFLC > 50 mg/l); 4. Cardiac function classification 1-3; 5. No serious arrhythmia; 6. accompanied by infection, thrombosis, hemorrhage and so on; 7. within 14 days before taking part in the group,the patients must meet the following conditions: 8. The absolute count of neutrophil granulocyte >=0.75 x10^9/l; 9. The platelet count 50 x 10^9/L or higher; 10. serum alkaline phosphatase < 3 times the upper limit of normal value; 11. serum total bilirubin < 1.5 times the upper limit of normal value; 12. serum alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value 13. serum aspartate aminotransferase (AST)<=2.5 times the upper limit of normal serum creatinine<=2 mg/dL (<=176.8 / l); 14. patients (or its legal representative) signed the informed consent form, showed that understand the purpose of research and process requirements, and willing to participate in this study.
Exclusion criteria
Exclusion criteria: Meet the following criteria may be subjects will be out of test: L known or suspected experimental drug allergy history; L merge multiple myeloma; L peripheral neuropathy CTCAE level 2 or higher; L pregnancy or lactation women, and not willing to take contraceptive measures in the study of patients;L in the group of the first six months, patients with Subjects who meet one of the following criteria may be will be out of test: Known or suspected experimental drug allergy history; Accompanying with multiple myeloma; peripheral neuropathy =CTCAE class 2; Pregnancy or lactation women, and patients who are not willing to take contraceptive measures in the study; whining the first six months before participating in the group, patients have uncontrolled or serious cardiovascular diseases, including myocardial infarction, the stage IV heart failure defined by NYHA (appendix 3), uncontrolled angina pectoris, pericardial disease, within 30 days with paroxysmal syncope; Accompanying with various types of active infection Accompanying with thrombosis or bleeding and so on; Have serious body disease or mental illness, can interfere with the clinical research; Other conditions unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall remission rate;partial remission;very good partial remission;Response Rate;Survival Data Analysis; | — |
Countries
China
Contacts
Public ContactLu Jin
People's Hospital, Beijing University
Outcome results
None listed