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）
Phase: PHASE4
Conditions: Immunoglobulin Light-Chain Amyloidosis
Sponsor: Guangdong Provincial People's Hospital

Project Name: BTD program and BCD program for the treatment of light 
amyloidosis: prospective, randomized, controlled clinical study program 
No.: v1.4 version date: August 9, 2019  
study unit: Guangdong People's Hospital  
sponsor: Guangdong People's Hospital  
thank you for your attention to this clinical study project! This informed 
consent is to introduce you to the project "prospective, randomized and 
controlled clinical study of BTD regimen and BCD regimen in the 
treatment of light amyloidosis". You have the right to choose whether to 
participate in this study or not. Information about this study is provided 
below to help you make your choice. Please read the following carefully. 
If you have any questions, please ask the researcher to make sure you 
understand the content correctly. If you decide to participate in this study, 
please sign on the last page. 
 
Objective  
There is no standard treatment plan for light chain (AL) amyloidosis at 
present. The purpose of this study is to explore the difference between 
bortezomib + thalidomide + dexamethasone (VTD) plan and bortezomib 
+ cyclophosphamide + dexamethasone (VCD) plan, and to provide more 
clinical evidence for the standard treatment of AL amyloidosis. 
 
Research contents 
Bortezomib (gjz-h20120299) is a proteasome inhibitor, thalidomide (gjz-
h32026129) 
and 
cyclophosphamide 
(gjz-h20110407) 
are 
immunosuppressants, which play a certain role in the treatment of AL 
amyloidosis and plasma cell disease. 
VTD group: bortezomib (1, 8, 15, 22 days, 1.3mg / m2, subcutaneous 
injection); thalidomide (long-term oral, 100mg, oral); dexamethasone (1, 
2, 8, 9, 15, 16, 22, 23 days, 40mg, oral) as a course of treatment, the 
patients will complete six courses of treatment, the overall observation 
time is one year after the end of treatment. VCD Scheme Group: 
bortezomib (1, 8, 15, 22 days, 1.3mg / m2, subcutaneous injection); 

cyclophosphamide (1, 2 days, 900MG / m2, intravenous drip); 
dexamethasone (1, 2, 8, 9, 15, 16, 22, 23 days, 40mg, oral 
administration) as a course of treatment, the patients will complete 6 
courses of treatment after entering the group, the overall observation 
time is treatment 1 year after the end. 
Before treatment and every month in the treatment cycle, relevant 
examinations should be done [blood routine (1 EDTA tube, 2ml 
peripheral blood), liver and kidney function (1 separate rubber tube, 5ml 
peripheral blood), infection index (2 glass drying tubes, 2ml peripheral 
blood), 24-hour urine protein quantification, blood light chain (1 glass 
drying tube, 2ml peripheral blood), urine light chain (1 urine tube, 2ml 
urine)], regular Bone marrow examination to evaluate the efficacy [bone 
marrow smear (1 EDTA tube, 0.5ml of bone marrow fluid, once every 
three months), bone marrow flow cytometry (1 EDTA tube, 3ml of bone 
marrow fluid, once every three months), bone marrow fusion gene fish 
examination (2 EDTA tubes, 4ml of bone marrow fluid, once at the initial 
diagnosis), bone marrow biopsy, etc.]. According to the research 
process 
and clinical visit 
plan, the chest 
CT, color Doppler 
echocardiography, ECG, 24-hour ambulatory blood pressure and other 
examinations were completed during the treatment. These tests are also 
necessary for your follow-up and examination in the treatment of AL 
amyloidosis. 
 
Risk of participation in this study 
 
In the study, the drugs that the patients will use have the following side 
effects: (1) bortezomib may have the following side effects in the use 
process: 
1. 
Blood 
system: 
anemia, 
thrombocytopenia; 
2. 
Gastrointestinal tract: constipation, diarrhea, nausea, vomiting, anorexia; 
3. Infection; 4. Benign, nausea and undefined tumors; 5. Systemic 
reaction: 
fatigue, 
lethargy, 
etc. 
（2 ） 
During 
the 
use 
of 
cyclophosphamide, the following side effects may occur: 1. 2. Liver 
damage. 3. Myelosuppression. 4. Immunosuppression, easy to infect. 5. 
Gastrointestinal tract: anorexia, nausea, vomiting, stomatitis, etc. 6. 

Hair loss, rash, mucosal ulcer, etc. 7. Renal hemorrhage, bladder 
fibrosis, hemorrhagic cystitis, hydronephrosis, vesicourethral reflux, etc. 
8. Carcinogenesis. 9. Pulmonary fibrosis. 10. Blurred vision, etc. * (three) 
during the use of hormone drugs, the following side effects may occur: 
1. gastrointestinal irritation, abdominal pain, nausea, vomiting, peptic 
ulcer, even gastrointestinal bleeding, perforation; 2. immunosuppression, 
easy to infect; 3. osteoporosis, including pathological fractures, 
vertebral compression fractures, femoral head necrosis, 4. diabetes, 5. 
water sodium retention, edema, hypertension, 6. full moon face. , 
centripetal obesity, purple lines, acne; 7. Menstrual disorders; 8. 
Children's growth and development are inhibited; 9. Mental disorders. 
（4） The main side effects of thalidomide are: 1. Teratogenicity. 2. Dry 
oral mucosa. 3. Burnout. 4. Rash. 5. Constipation, nausea and 
abdominal pain. 6. Neuralgia, postherpetic neuralgia, peripheral 
neuropathy, sensory abnormality, sensory disturbance, dizziness 
(excluding vertigo), headache, taste disturbance, 7. Hyperbilirubinemia, 
hepatitis, alt, AST, ALP and γ - glutamyltransferase. 8. Allergic reaction. 
9. 
Thrombocytopenia, 
anemia, 
neutropenia, 
lymphocytopenia, 
pancytopenia, febrile neutropenia, septicemia, bacteremia, leukopenia. 
Disseminated intravascular coagulation is rare. Platelet dysfunction may 
also occur. 10. Blurred vision, conjunctival infection and irritation. 
Herpes oculi is rare. Hearing loss. Bilateral deafness is rare. According 
to the literature reports, the main side effects that may be caused by the 
combination of drugs include infection (7-10%), anemia (4.1-9.5%), 
gastrointestinal symptoms (3.5-5.3%), peripheral neurotoxicity (12-21%). 
Doctors will regularly detect the side effects of drugs and give preventive 
and treatment measures to reduce the damage of side effects of drugs. 
These adverse events are not necessarily related to drugs. If the 
symptoms are mild, special treatment is not needed. If there are adverse 
events related to the study, the study doctor will take appropriate 
treatment measures according to the situation. 
 
 
 

Benefits of participating in this study 
During your participation in this study, you will receive comprehensive 
medical services and standardized treatment of amyloidosis. During the 
treatment, we will inform you the results of each examination, evaluate 
the safety of the drug and deal with possible adverse events. 
 
Voluntary participation / withdrawal from the study 
This study is approved by the ethics committee of our hospital. The 
subjects are totally voluntary. You can refuse to participate or withdraw 
at any time. You will not be punished or lose your rights and interests, 
and will not be treated unfairly. If you want to withdraw from the study, 
you must inform the research doctor. If you need other treatment, or do 
not follow the study plan, or have injury related to the study or for any 
other reason, you can be withdrawn from the study without your consent. 
If the study doctor is sure that it will be bad for you to continue to 
participate in the study, he can terminate your continued participation in 
the study at any time, or even without your consent, if You quit the study 
in advance, and your doctor will ask you to go to the hospital for the final 
examination and evaluation (including physical examination and 
laboratory examination). If you quit the study, to the extent permitted by 
the relevant laws / regulations, the research materials obtained before 
you quit may still be adopted. 
 
Cost description of participating in the study 
The implementation of the study plan needs to be carried out by patients 
in hospital. Therefore, the cost of drug use and inspection is the inpatient 
cost, which is borne by the patients themselves. No free drugs and 
inspection. 
 
Subjects cooperation 
During the whole study period, the subjects will be treated in the form of 
hospitalization according to the arrangement of the researchers, and 
your blood, urine and bone marrow samples collected during the study 
period will be tested. The researchers will determine the treatment time 
of the next treatment course according to the patient's condition changes 
during each treatment course. 

Protection of privacy 
The data of this study will be finally archived in Guangdong People's 
Hospital, and the research results may also be published. But your 
identity will not be revealed in the publication. 
 
Contact information 
For research related injuries or discomfort during the research, please 
contact Dr. Li Sheng, researcher, at 13824454728. If you have any 
questions about the rights and interests or ethics of subjects in this study, 
please contact the ethics committee of Guangdong People's Hospital at 
83827812-20984 
 
After signing the informed consent form, I agree: (the following "I" refers 
to the subject) A kind of I have read this informed consent.  
A kind of I have the opportunity to ask questions and all questions have 
been answered.  
A kind of I understand that participation in this study is entirely voluntary. 
A kind of As described in this consent, I agree to allow the sponsor, 
clinician and interested parties to use and share my medical information 
to the extent permitted by law.  
A kind of I can choose not to participate in this study, or withdraw after 
informing the study doctor at any time. I will not be punished or lose any 
due benefits.  
A kind of If I need other treatment, or if I fail to follow the study plan, or 
if there is a study-related injury or for any other reason, the clinician can 
withdraw me from the study without my consent. 
A kind of If for any reason I withdraw from this study, the researchers 
may request some final examination for me. 
I will receive a signed copy of the informed consent.  
Subject's signature:                 Date: MM DD YY;  
Witness's signature:                 Date: MM DD YY;  
Researcher's signature:              Date: MM DD YY;  
Researcher's phone number: