Clinical trial NCT03860038: TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma in Relapse
Refractory Multiple Myeloma
Lead sponsor: TJ Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
Secondary outcomes:
measure: Clinical benefit rate (CBR)
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
measure: Duration of response (DOR)
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
measure: Time to progression (TTP)
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
measure: Time to response (TTR)
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
measure: Progression-free survival (PFS)
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
measure: Overall survival (OS)
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
Other outcomes:
measure: minimal residual disease (MRD) assessment
timeFrame: end of study [ Time Frame: Approximately up to 2 years ]
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital,Capital medical university
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital of SMU
state: Guandong
city: Shenzhen
country: China
facility: The second people's Hospital of Shenzhen
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangzhou
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: The first Bethune hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Taiwan
country: China
facility: National Taiwan University Hospital
state: Taiwan
city: Taiwan
country: China
facility: Tri-Service General Hospital
state: Taiwan
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital，affiliated with the Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine,Zhejiang University
state: Zhejiang
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
name: Lugui Qiu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: