Clinical trial NCT03952091: TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma in Relapse
Refractory Multiple Myeloma
Lead sponsor: TJ Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-16
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18, male or female;
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:

1. Subject has received anti-CD38 monoclonal antibody treatment previously;
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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 18.4 months(Active) 30.7 months(experimental)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University (CMU) - Beijing Chao-Yang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Capital Medical University (CMU) - Beijing Chao-Yang Hospital
state: Beijing
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical college
state: Bengbu
city: Jilin
country: China
facility: The First Bethune Hospital of Jilin University
state: Changchun
city: Hunan
country: China
facility: Hunan Cancer Hospital
state: Changsha
city: Fujian
country: China
facility: Fujian Medical University Union Hospital
state: Fuzhou
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangdong
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangzhou
city: Guangdong
country: China
facility: Guangdong General Hospital
state: Guangzhou
city: Guangdong
country: China
facility: Guangzhou First People's Hospital
state: Guangzhou
city: Guangdong
country: China
facility: Nanfang Hospital
state: Guangzhou
city: Zhejiang
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Hangzhou
city: Zhejiang
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Hangzhou
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Taiwan
country: China
facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
state: Kaohsiung
city: Yunnan
country: China
facility: The second affiliated hospital of Kunming medical university
state: Kunming
city: Yunnan
country: China
facility: The First People's Hospital of Yunnan Province
state: Kunming
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Lanzhou
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Lanzhou
city: Jiangxi
country: China
facility: Second Affiliated Hospital of Nanchang University
state: Nanchang
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Nanjing
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Nanjing
city: Guangxi
country: China
facility: Guangxi Medical Univ. 1st Hospital
state: Nanning
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine - Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Shenyang
city: Guangdong
country: China
facility: Shenzhen Second Hospital
state: Shenzhen
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Suzhou
city: Taiwan
country: China
facility: National Taiwan University Hospital
state: Taibei
city: Taiwan
country: China
facility: Taichung Veterans General Hospital
state: Taichung
city: Taiwan
country: China
facility: Tri-Service General Hospital
state: Taipei
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Zhejiang
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Wenzhou
city: Hubei
country: China
facility: The Central Hospital Of Wuhan
state: Wuhan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Henan
country: China
facility: Henan Cancer Hospital
state: Zhengzhou
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: