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Trial record 1 of 2 for:    TJ202
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TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03860038
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma HongKong Limited

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE January 28, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
Overall response rate (ORR) [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03860038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
  • Clinical benefit rate (CBR) [ Time Frame: end of study [ Time Frame: Approximately up to 2 years ] ]
  • Duration of response (DOR) [ Time Frame: end of study [ Time Frame: Approximately up to 2 years ] ]
  • Time to progression (TTP) [ Time Frame: end of study [ Time Frame: Approximately up to 2 years ] ]
  • Time to response (TTR) [ Time Frame: end of study [ Time Frame: Approximately up to 2 years ] ]
  • Progression-free survival (PFS) [ Time Frame: end of study [ Time Frame: Approximately up to 2 years ] ]
  • Overall survival (OS) [ Time Frame: end of study [ Time Frame: Approximately up to 2 years ] ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2019)
minimal residual disease (MRD) assessment [ Time Frame: end of study [ Time Frame: Approximately up to 2 years ] ]
For subjects reaching CR and above, their bone marrow samples will be collected for exploratory minimal residual disease (MRD) assessment at the central laboratory.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma in Relapse
  • Refractory Multiple Myeloma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: TJ202
Intervention: Drug: TJ202 and Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2019)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shanshan Gao, Bachelor 86-021-60578024 shanshan.gao@i-mabbiopharma.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03860038
Other Study ID Numbers  ICMJE TJ202001MMY201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party I-Mab Biopharma HongKong Limited
Study Sponsor  ICMJE I-Mab Biopharma HongKong Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lugui Qiu, Doctor Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
PRS Account I-Mab Biopharma HongKong Limited
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP