Main
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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:
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ChiCTR |
Last refreshed on:
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2 October 2017 |
Main ID: |
ChiCTR-IPR-17012637 |
Date of registration:
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2017-09-11 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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2017-10-01 |
Target sample size:
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Group 1:35;Group 2:35; |
Recruitment status: |
Pending |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=21447 |
Study type:
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Interventional study |
Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Li Sheng
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Address:
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106 Second Zhongshan Road, Guangzhou, Guangdong, China
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Telephone:
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+86 13824454728 |
Email:
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lishirea@163.com |
Affiliation:
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Guangdong General Hospital |
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Name:
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Wang Wenjian
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Address:
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106 Second Zhongshan Road, Guangzhou, Guangdong, China
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Telephone:
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+86 13928985527 |
Email:
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wwjph@126.com |
Affiliation:
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Guangdong General Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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type AL amyloidosis
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Intervention(s)
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Group 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD);
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Primary Outcome(s)
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complete remission;Organ response rate;
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Secondary Outcome(s)
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very good partial remission;partial remission;Survival Data Analysis;Overall survival rate;Progression free survival;
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Source(s) of Monetary Support
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self-paying
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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