TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Refractory Multiple Myeloma Clinical Trial

Official title:

A Phase 2, Multi-center, Single-arm Study of TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 2 Prior Lines of Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03860038
• Other study ID #: TJ202001MMY201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 28, 2019
• Est. completion date: December 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

This trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.

Description:

A total of 82 subjects with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of treatment will be enrolled in this study. Prior lines of treatment must include a proteasome inhibitor (PI) and an immunomodulator (IMiD). All subjects will receive TJ202 and dexamethasone (DEX) in the study. The treatment will continue until endpoint events such as intolerance or progressive disease (PD).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: December 31, 2024
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Age = 18, male or female;

2. Subject must have had documented MM;

3. At screening phase, subject must have measurable disease;

4. Subject is in a state of progressive disease (PD);

5. Subject must have life expectancy of no less than 6 months;

6. Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;

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 (subject failed to generate any minimal response or any degree of response to any therapy);

5. Subject has received anti-myeloma treatment (radiotherapy is excluded) within 4 weeks or 5 PK half-lives of the treatment, whichever longer, before the first study agent administration.

Related Conditions & MeSH terms

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

Intervention

Drug:
• TJ202 and Dexamethasone
one dose of TJ202 16 mg/kg or an adjusted dose will be administered on Day 1 and Day 4 of Week 1, then every week from Week 2 to Week 12, then every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter, until the subjects experience an onset of endpoint events like intolerance or PD. DEX 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital,Capital medical university	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The first Bethune hospital of Jilin University	Changchun	Jilin
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Nanfang Hospital of SMU	Guangzhou	Guandong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangzhou
China	Sir Run Run Shaw Hospital,affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital, College of Medicine,Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	The second people's Hospital of Shenzhen	Shenzhen	Guangdong
China	National Taiwan University Hospital	Taiwan	Taiwan
China	Tri-Service General Hospital	Taiwan	Taiwan
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan
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
Other	minimal residual disease (MRD) assessment	For subjects reaching CR and above, their bone marrow samples will be collected for exploratory minimal residual disease (MRD) assessment at the central laboratory.	end of study [ Time Frame: Approximately up to 2 years ]
Primary	Overall response rate (ORR)	defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)	end of study [ Time Frame: Approximately up to 2 years ]
Secondary	Clinical benefit rate (CBR)		end of study [ Time Frame: Approximately up to 2 years ]
Secondary	Duration of response (DOR)		end of study [ Time Frame: Approximately up to 2 years ]
Secondary	Time to progression (TTP)		end of study [ Time Frame: Approximately up to 2 years ]
Secondary	Time to response (TTR)		end of study [ Time Frame: Approximately up to 2 years ]
Secondary	Progression-free survival (PFS)		end of study [ Time Frame: Approximately up to 2 years ]
Secondary	Overall survival (OS)		end of study [ Time Frame: Approximately up to 2 years ]