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

Phase 2

Completed

• Conditions: Multiple Myeloma in Relapse; Refractory Multiple Myeloma
• Interventions: Drug: TJ202 and Dexamethasone

• Registration Number: NCT03860038
• Lead Sponsor: TJ Biopharma Co., Ltd.

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2019-01-15
• Study Start: 2019-01-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Primary Completion: 2023-01-28
• Study Completion: 2023-01-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TJ202	TJ202 and Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	end of study [ Time Frame: Approximately up to 2 years ]	defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Time to response (TTR)	end of study [ Time Frame: Approximately up to 2 years ]
Time to progression (TTP)	end of study [ Time Frame: Approximately up to 2 years ]
Duration of response (DOR)	end of study [ Time Frame: Approximately up to 2 years ]
Clinical benefit rate (CBR)	end of study [ Time Frame: Approximately up to 2 years ]
Progression-free survival (PFS)	end of study [ Time Frame: Approximately up to 2 years ]
Overall survival (OS)	end of study [ Time Frame: Approximately up to 2 years ]

Trial Locations

Locations (18)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Sir Run Run Shaw Hospital，affiliated with the Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Beijing Chao-Yang Hospital,Capital medical university; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital of SMU; 🇨🇳 Guangzhou, Guandong, China

The second people's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangzhou, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

The first Bethune hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

National Taiwan University Hospital; 🇨🇳 Taiwan, Taiwan, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China

Tri-Service General Hospital; 🇨🇳 Taiwan, Taiwan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital, College of Medicine,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China