Trial record 1 of 2 for:
tj202
TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT03860038 |
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Recruitment Status :
Recruiting
First Posted : March 1, 2019
Last Update Posted : September 21, 2020
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Sponsor:
I-Mab Biopharma Co. Ltd.
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.
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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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 82 participants |
| Allocation: | N/A |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| 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 :
- 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 :
- 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 ] ]
Other Outcome Measures:
- 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:
- 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.
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
| Contact: Shanshan Gao, Bachelor | 86-021-60578024 | shanshan.gao@i-mabbiopharma.com |
Locations
Show 25 study locations
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
Investigators
| Principal Investigator: | Lugui Qiu, Doctor | Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC |
| Responsible Party: | I-Mab Biopharma Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT03860038 |
| Other Study ID Numbers: |
TJ202001MMY201 |
| First Posted: | March 1, 2019 Key Record Dates |
| Last Update Posted: | September 21, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 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 |