TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 3, Randomized, Open-label, Parallel-controlled, Multi-center Study Comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 1 Prior Line of Treatment
1 other identifier
interventional
289
2 countries
41
Brief Summary
A phase 3, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in subjects with relapsed or refractory multiple myeloma who received at least 1 prior line of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2019
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2019
CompletedFirst Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 3, 2024
July 1, 2024
5.3 years
May 14, 2019
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first
18.4 months(Active) 30.7 months(experimental)
Study Arms (2)
TJ202, Lenalidomide and Dexamethasone
EXPERIMENTALLenalidomide and Dexamethasone
ACTIVE COMPARATORInterventions
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 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.
Eligibility Criteria
You may qualify if:
- Age ≥ 18, male or female;
- Subjects must have had documented MM;
- At the screening phase, subject must have one or more measurable disease;
- Subjects must have received at least 1 prior line treatment\* for relapsed or refractor MM;
- Subjects who are in a state of progressive disease (PD);
- Subjects must have life expectancy of no less than 6 months;
- Subjects must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0\~2;
- 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;
- 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;
- 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;
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
You may not qualify if:
- Subject has received anti-CD38 monoclonal antibody treatment previously;
- Subject has received CAR-T cell therapy previously;
- 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;
- Primary refractory multiple myeloma;
- Subject's disease shows evidence of resistance to lenalidomide;
- Subject's disease shows evidence of intolerance to lenalidomide;
- Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM;
- Subjects with known moderate or severe persistent asthma within the past 5 years;
- Subject has active hepatitis B or C virus infection15. Subject is seropositive for human immunodeficiency virus (HIV);
- Subject has clinically significant cardiac disease;
- 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;
- Subject with known or suspicious conditions that would lead to failure to abide by the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Capital Medical University (CMU) - Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100083, 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, 130021, China
Hunan Cancer Hospital
Hunan, Changsha, China
Fujian Medical University Union Hospital
Fujian, Fuzhou, 350001, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangdong, Guangzhou, 510060, China
Guangdong General Hospital
Guangdong, Guangzhou, 510080, China
Guangzhou First People's Hospital
Guangdong, Guangzhou, 510180, China
Nanfang Hospital
Guangdong, Guangzhou, 510515, China
The First Affiliated Hospital of Zhejiang University
Zhejiang, Hangzhou, 310003, 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, 833, China
The second affiliated hospital of Kunming medical university
Yunnan, Kunming, 650101, China
The First People's Hospital of Yunnan Province
Yunnan, Kunming, 650221, China
The First Hospital of Lanzhou University
Lanzhou, Lanzhou, 730000, China
Lanzhou University Second Hospital
Lanzhou, Lanzhou, 730030, China
Second Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, Nanjing, 210008, China
Jiangsu Province Hospital
Nanjing, Nanjing, 210029, China
Guangxi Medical Univ. 1st Hospital
Guangxi, Nanning, 530021, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanghai Jiao Tong University School of Medicine - Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
The First Hospital of China Medical University
Shenyang, Shenyang, 110001, China
Shenzhen Second Hospital
Guangdong, Shenzhen, 518035, China
The First Affiliated Hospital of Soochow University
Suzhou, Suzhou, 215006, China
National Taiwan University Hospital
Taiwan, Taibei, 100, China
Taichung Veterans General Hospital
Taiwan, Taichung, 40705, China
Tri-Service General Hospital
Taiwan, Taipei, 114, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital of Wenzhou Medical University
Zhejiang, Wenzhou, 325000, China
The Central Hospital Of Wuhan
Hubei, Wuhan, 430014, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Henan Cancer Hospital
Henan, Zhengzhou, 450008, China
Taipei Veterans General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2019
First Posted
May 16, 2019
Study Start
March 27, 2019
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
July 3, 2024
Record last verified: 2024-07