TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT03952091
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
289 participants
INTERVENTIONAL
2019-03-27
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TJ202, Lenalidomide and Dexamethasone
TJ202, Lenalidomide and Dexamethasone
One dose of TJ202 will be given on Day 1 and Day 4 of Week 1, respectively, every week from Week 2 to Week 12, every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter.Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
Lenalidomide and Dexamethasone
Lenalidomide and Dexamethasone
Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.
Interventions
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TJ202, Lenalidomide and Dexamethasone
One dose of TJ202 will be given on Day 1 and Day 4 of Week 1, respectively, every week from Week 2 to Week 12, every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter.Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
Lenalidomide and Dexamethasone
Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.
Eligibility Criteria
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Inclusion Criteria
2. Subjects must have had documented MM;
3. At the screening phase, subject must have one or more measurable disease;
4. Subjects must have received at least 1 prior line treatment\* for relapsed or refractor MM;
5. Subjects who are in a state of progressive disease (PD);
6. Subjects must have life expectancy of no less than 6 months;
7. Subjects must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0\~2;
8. A woman of child-bearing potential must have a negative serum pregnancy test within 14 days prior to the first study agent administration, and a negative urine pregnancy test on the day of the first study agent administration; as well as those should avoid sexual intercourse with the opposite sex or should adopt two reliable methods of contraception at the same time during the study period. A woman of child-bearing potential is required to take effective contraceptive measures throughout this study and within 6 months after the last dosing; female subjects must agree not to donate any eggs for the purpose of assisted reproduction throughout this study and within 6 months after completion of this study;
9. Male subjects who are sexually active with women of child-bearing potential and have not undergone vasoligation must agree to use barrier methods of birth control, or that their partners use block caps (cervical cap or dome cap), spermicidal foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, or suppository, and all male subjects are not allowed to donate sperms throughout this study and within 6 months after the last dosing;
10. Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study;
11. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion Criteria
2. Subject has received CAR-T cell therapy previously;
3. Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent;
4. Primary refractory multiple myeloma;
5. Subject's disease shows evidence of resistance to lenalidomide;
6. Subject's disease shows evidence of intolerance to lenalidomide;
7. Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM;
8. Subjects with known moderate or severe persistent asthma within the past 5 years;
9. Subject has active hepatitis B or C virus infection15. Subject is seropositive for human immunodeficiency virus (HIV);
10. Subject has clinically significant cardiac disease;
11. Subject has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products;
12. Subject with known or suspicious conditions that would lead to failure to abide by the study protocol.
18 Years
ALL
No
Sponsors
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TJ Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Capital Medical University (CMU) - Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Capital Medical University (CMU) - Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Bengbu Medical college
Bengbu, Bengbu, China
The First Bethune Hospital of Jilin University
Jilin, Changchun, China
Hunan Cancer Hospital
Hunan, Changsha, China
Fujian Medical University Union Hospital
Fujian, Fuzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangdong, Guangzhou, China
Guangdong General Hospital
Guangdong, Guangzhou, China
Guangzhou First People's Hospital
Guangdong, Guangzhou, China
Nanfang Hospital
Guangdong, Guangzhou, China
The First Affiliated Hospital of Zhejiang University
Zhejiang, Hangzhou, China
The First Affiliated Hospital of Zhejiang University
Zhejiang, Hangzhou, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Taiwan, Kaohsiung, China
The second affiliated hospital of Kunming medical university
Yunnan, Kunming, China
The First People's Hospital of Yunnan Province
Yunnan, Kunming, China
The First Hospital of Lanzhou University
Lanzhou, Lanzhou, China
Lanzhou University Second Hospital
Lanzhou, Lanzhou, China
Second Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, Nanjing, China
Jiangsu Province Hospital
Nanjing, Nanjing, China
Guangxi Medical Univ. 1st Hospital
Guangxi, Nanning, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Shanghai Jiao Tong University School of Medicine - Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
The First Hospital of China Medical University
Shenyang, Shenyang, China
Shenzhen Second Hospital
Guangdong, Shenzhen, China
The First Affiliated Hospital of Soochow University
Suzhou, Suzhou, China
National Taiwan University Hospital
Taiwan, Taibei, China
Taichung Veterans General Hospital
Taiwan, Taichung, China
Tri-Service General Hospital
Taiwan, Taipei, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical University
Zhejiang, Wenzhou, China
The Central Hospital Of Wuhan
Hubei, Wuhan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Henan Cancer Hospital
Henan, Zhengzhou, China
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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TJ202001MMY301
Identifier Type: -
Identifier Source: org_study_id
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