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Completed

NCT Number: NCT03860038

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Chao-Yang Hospital,Capital medical university, Beijing, Beijing Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18, male or female;
  • Subject must have had documented MM;
  • At screening phase, subject must have measurable disease;
  • Subject is in a state of progressive disease (PD);
  • Subject must have life expectancy of no less than 6 months;
  • Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;

Exclusion criteria

  • Subject has received anti-CD38 monoclonal antibody treatment previously;
  • Subject has received CAR-T cell therapy previously;
  • 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;
  • Primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy);
  • 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.

Treatment and study plan

TJ202 and Dexamethasone

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Clinical benefit rate (CBR)

    Time frame: end of study [ Time Frame: Approximately up to 2 years ]

  2. Duration of response (DOR)

    Time frame: end of study [ Time Frame: Approximately up to 2 years ]

  3. Time to progression (TTP)

    Time frame: end of study [ Time Frame: Approximately up to 2 years ]

  4. Time to response (TTR)

    Time frame: end of study [ Time Frame: Approximately up to 2 years ]

  5. Progression-free survival (PFS)

    Time frame: end of study [ Time Frame: Approximately up to 2 years ]

  6. Overall survival (OS)

    Time frame: end of study [ Time Frame: Approximately up to 2 years ]

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

TJ Biopharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2019
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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