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

Sponsor
I-Mab Biopharma Co. Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03952091
Collaborator
(none)
291
Enrollment
41
Locations
2
Arms
40.1
Anticipated Duration (Months)
7.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: TJ202, Lenalidomide and Dexamethasone
  • Drug: Lenalidomide and Dexamethasone
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
291 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 27, 2019
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TJ202, Lenalidomide and Dexamethasone

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.
Active Comparator: Lenalidomide and Dexamethasone

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [18.4 months(Active) 30.7 months(experimental)]

    defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Capital Medical University (CMU) - Beijing Chao-Yang Hospital Beijing Beijing China 100020
2 Peking University Third Hospital Beijing Beijing China 100083
3 Capital Medical University (CMU) - Beijing Chao-Yang Hospital Beijing Beijing China
4 The First Affiliated Hospital of Bengbu Medical college Bengbu Bengbu China
5 The First Bethune Hospital of Jilin University Jilin Changchun China 130021
6 Hunan Cancer Hospital Hunan Changsha China
7 Fujian Medical University Union Hospital Fujian Fuzhou China 350001
8 The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong China
9 Sun Yat-Sen University Cancer Center Guangdong Guangzhou China 510060
10 Guangdong General Hospital Guangdong Guangzhou China 510080
11 Guangzhou First People's Hospital Guangdong Guangzhou China 510180
12 Nanfang Hospital Guangdong Guangzhou China 510515
13 The First Affiliated Hospital of Zhejiang University Zhejiang Hangzhou China 310003
14 The First Affiliated Hospital of Zhejiang University Zhejiang Hangzhou China
15 Hubei Cancer Hospital Wuhan Hubei China
16 Affiliated Hospital of Nantong University Nantong Jiangsu China
17 Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital Taiwan Kaohsiung China 833
18 The second affiliated hospital of Kunming medical university Yunnan Kunming China 650101
19 The First People's Hospital of Yunnan Province Yunnan Kunming China 650221
20 The First Hospital of Lanzhou University Lanzhou Lanzhou China 730000
21 Lanzhou University Second Hospital Lanzhou Lanzhou China 730030
22 Second Affiliated Hospital of Nanchang University Jiangxi Nanchang China 330006
23 Nanjing Drum Tower Hospital Nanjing Nanjing China 210008
24 Jiangsu Province Hospital Nanjing Nanjing China 210029
25 Guangxi Medical Univ. 1st Hospital Guangxi Nanning China 530021
26 Shanghai Changzheng Hospital Shanghai Shanghai China 200000
27 Shanghai Jiao Tong University School of Medicine - Ruijin Hospital Shanghai Shanghai China 200025
28 Shanghai Sixth People's Hospital Shanghai Shanghai China 200233
29 The First Hospital of China Medical University Shenyang Shenyang China 110001
30 Shenzhen Second Hospital Guangdong Shenzhen China 518035
31 The First Affiliated Hospital of Soochow University Suzhou Suzhou China 215006
32 National Taiwan University Hospital Taiwan Taibei China 100
33 Taichung Veterans General Hospital Taiwan Taichung China 40705
34 Tri-Service General Hospital Taiwan Taipei China 114
35 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
36 Tianjin Cancer Hospital Tianjin Tianjin China 300060
37 The First Affiliated Hospital of Wenzhou Medical University Zhejiang Wenzhou China 325000
38 The Central Hospital Of Wuhan Hubei Wuhan China 430014
39 Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China
40 Henan Cancer Hospital Henan Zhengzhou China 450008
41 Taipei Veterans General Hospital Taipei Taiwan

Sponsors and Collaborators

  • I-Mab Biopharma Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov Identifier:
NCT03952091
Other Study ID Numbers:
  • TJ202001MMY301
First Posted:
May 16, 2019
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101

Study Results

No Results Posted as of Jul 26, 2022