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)

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-16008422
• Date of registration: 2016-05-08
• Prospective Registration: No
• 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: Lu Jin
• Affiliation: People's Hospital, Beijing University

• Name: Wang Guomiao
• 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;

Source(s) of Monetary Support

self-paying