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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

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma in Relapse Refractory Multiple Myeloma Drug: TJ202 and Dexamethasone Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: TJ202 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860038


Contacts
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Contact: Shanshan Gao, Bachelor 86-021-60578024 shanshan.gao@i-mabbiopharma.com

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Tzeon-Jye Chiou, Doctor         
Sponsors and Collaborators
I-Mab Biopharma HongKong Limited
Investigators
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Principal Investigator: Lugui Qiu, Doctor Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC

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Responsible Party: I-Mab Biopharma HongKong Limited
ClinicalTrials.gov Identifier: NCT03860038     History of Changes
Other Study ID Numbers: TJ202001MMY201
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors