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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04612582
Date of registration: 15/06/2020
Prospective Registration: Yes
Primary sponsor: Guangdong Provincial People's Hospital
Public title: Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis
Scientific title: A Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial(BTD-CHINA-TRIAL)
Date of first enrolment: January 1, 2020
Target sample size: 70
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04612582
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
China
Contacts
Name:     Wenjian Wang, PhD
Address: 
Telephone: 0086-020-83827812-61421
Email: wwjph@126.com
Affiliation: 
Name:     Wenjian Wang, PhD
Address: 
Telephone: 0086-020-83827812-61421
Email: wwjph@126.com
Affiliation: 
Name:     Wenjian Wang, PhD
Address: 
Telephone:
Email:
Affiliation:  Guangdong Provincial People's Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

1.Signed the written informed consent; 2.18 years old = age = 80 years old, no restriction
on gender; 3.AL amyloidosis was confirmed by pathological biopsy in the accumulated system
or organ (kidney, heart, liver, skin), and excluded other secondary factors; 4.The
proliferation of monoclonal plasma cells was confirmed by fixed electrophoresis of bone
marrow or blood/urine.

Exclusion Criteria:

1. Pathological biopsy showed non-AL amyloidosis;

2. Abnormal proliferation of plasma cells reached the standard of multiple myeloma;

3. Other hematological system tumors;

4. Cushing's syndrome;

5. Active hepatitis;

5.Pregnant or lactating women;



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Immunoglobulin Light-Chain Amyloidosis
Intervention(s)
Drug: Cyclophosphamide
Drug: Thalidomide
Primary Outcome(s)
Hematologic Response [Time Frame: 1 year]
Secondary Outcome(s)
Organ Response [Time Frame: 1 year]
Secondary ID(s)
WJWang001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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