TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952091
• Other study ID #: TJ202001MMY301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 27, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: TJ Biopharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 291
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Capital Medical University (CMU) - Beijing Chao-Yang Hospital	Beijing	Beijing
China	Capital Medical University (CMU) - Beijing Chao-Yang Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical college	Bengbu	Bengbu
China	Fujian Medical University Union Hospital	Fujian	Fuzhou
China	Guangdong General Hospital	Guangdong	Guangzhou
China	Guangzhou First People's Hospital	Guangdong	Guangzhou
China	Nanfang Hospital	Guangdong	Guangzhou
China	Shenzhen Second Hospital	Guangdong	Shenzhen
China	Sun Yat-Sen University Cancer Center	Guangdong	Guangzhou
China	Guangxi Medical Univ. 1st Hospital	Guangxi	Nanning
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Henan Cancer Hospital	Henan	Zhengzhou
China	The Central Hospital Of Wuhan	Hubei	Wuhan
China	Hunan Cancer Hospital	Hunan	Changsha
China	Second Affiliated Hospital of Nanchang University	Jiangxi	Nanchang
China	The First Bethune Hospital of Jilin University	Jilin	Changchun
China	Lanzhou University Second Hospital	Lanzhou	Lanzhou
China	The First Hospital of Lanzhou University	Lanzhou	Lanzhou
China	Jiangsu Province Hospital	Nanjing	Nanjing
China	Nanjing Drum Tower Hospital	Nanjing	Nanjing
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai Jiao Tong University School of Medicine - Ruijin Hospital	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Shenyang
China	The First Affiliated Hospital of Soochow University	Suzhou	Suzhou
China	Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital	Taiwan	Kaohsiung
China	National Taiwan University Hospital	Taiwan	Taibei
China	Taichung Veterans General Hospital	Taiwan	Taichung
China	Tri-Service General Hospital	Taiwan	Taipei
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The First People's Hospital of Yunnan Province	Yunnan	Kunming
China	The second affiliated hospital of Kunming medical university	Yunnan	Kunming
China	The First Affiliated Hospital of Wenzhou Medical University	Zhejiang	Wenzhou
China	The First Affiliated Hospital of Zhejiang University	Zhejiang	Hangzhou
China	The First Affiliated Hospital of Zhejiang University	Zhejiang	Hangzhou
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TJ Biopharma Co., Ltd.

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)