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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-IPR-16008422
Date of registration: 2016-05-08
Prospective Registration: Yes
Primary sponsor: People's Hospital, Beijing University
Public title: Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL)
Scientific title: Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL)
Date of first enrolment: 2016-05-05
Target sample size: the first group:60;the second group:60;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=14274
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  Post-market
Countries of recruitment
China
Contacts
Name: Wang Guomiao   
Address:  11 South Street, Xizhimen, Xicheng District, Beijing 100044
Telephone: +86 15110104853
Email: 13465851837@163.com
Affiliation:  People's Hospital, Beijing University
Name: Lu Jin   
Address:  11 South Street, Xizhimen, Xicheng District, Beijing 100044
Telephone: +86 13311491805
Email: jin1lu@sina.com
Affiliation:  People's Hospital, Beijing University
Key inclusion & exclusion 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: 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.


Age minimum: 18
Age maximum: 75
Gender: Both
Health Condition(s) or Problem(s) studied
primary systemic amyloidosis (AL)
Intervention(s)
the first group: the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD);the second group:the combination regimen of bortezomib +thalidomide + dexamethasone (BTD) ;
Primary Outcome(s)
complete remission;
Secondary Outcome(s)
overall remission rate;partial remission;very good partial remission;Response Rate;Survival Data Analysis;
Secondary ID(s)
Source(s) of Monetary Support
self-paying
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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