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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: 2 October 2017
Main ID:  ChiCTR-IPR-17012637
Date of registration: 2017-09-11
Prospective Registration: Yes
Primary sponsor: Guangdong General Hospital
Public title: Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis
Scientific title: Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis
Date of first enrolment: 2017-10-01
Target sample size: Group 1:35;Group 2:35;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=21447
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  Post-market
Countries of recruitment
China
Contacts
Name: Li Sheng   
Address:  106 Second Zhongshan Road, Guangzhou, Guangdong, China
Telephone: +86 13824454728
Email: lishirea@163.com
Affiliation:  Guangdong General Hospital
Name: Wang Wenjian   
Address:  106 Second Zhongshan Road, Guangzhou, Guangdong, China
Telephone: +86 13928985527
Email: wwjph@126.com
Affiliation:  Guangdong General Hospital
Key inclusion & exclusion criteria
Inclusion criteria: (1) signed a written informed consent;
(2) aged between 18 and 75 years male or female;
(3) primary disease accumulated by the system or organ (kidney, heart, liver, skin biopsy) clear AL amyloidosis, investigation and other secondary factors;
(4) bone marrow or blood / urine fixed electrophoresis tips monoclonal plasmacytosis.

Exclusion criteria: (1) biopsy for non AL amyloidosis;
(2) plasma cells of multiple myeloma or other hematologic malignancies;
(3) related diseases complicated with glaucoma, severe osteoporosis and peptic ulcer hemorrhage / history, mental disorders, Cushing syndrome and other hormone taboo;
(4) combined infection, hepatitis, tuberculosis or other immunosuppressive taboo of the disease;
(5) pregnant or lactating women;
(6) there is a history of allergies or nearly 4 weeks of acute or chronic allergy to drugs used in clinical trials; (10) the life of less than expected 1 years;
(11) the researchers estimate the compliance of patients is not suitable to participate in this study;
(12) the past or present a history of cancer, the risk of tumor recurrence or metastasis.


Age minimum: 18
Age maximum: 75
Gender: Both
Health Condition(s) or Problem(s) studied
type AL amyloidosis
Intervention(s)
Group 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD);
Primary Outcome(s)
complete remission;Organ response rate;
Secondary Outcome(s)
very good partial remission;partial remission;Survival Data Analysis;Overall survival rate;Progression free survival;
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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