Multiple Myeloma in RelapsePhase 2NCT03860038
TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing TJ202 and Dexamethasone in people with Multiple Myeloma in Relapse and Refractory Multiple Myeloma, run by TJ Biopharma Co., Ltd. at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Refractory Multiple Myeloma
- What is being tested?
- TJ202 and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 28 Jan 2019to 28 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
China17 sites
Beijing Chao-Yang Hospital,Capital medical university
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
The first Bethune hospital of Jilin University
Changchun, Jilin
Fujian Medical University Union Hospital
Fuzhou, Fujian
Nanfang Hospital of SMU
Guangzhou, Guandong
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou
Sir Run Run Shaw Hospital，affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital, College of Medicine,Zhejiang University
Hangzhou, Zhejiang
Jiangsu Province Hospital
Nanjing, Jiangsu
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
The second people's Hospital of Shenzhen
Shenzhen, Guangdong
National Taiwan University Hospital
Taiwan, Taiwan
Tri-Service General Hospital
Taiwan, Taiwan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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
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.
Read the 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).
- Being tested
- TJ202 and Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ202 and DexamethasoneDrug
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 group | Role | What they receive |
|---|---|---|
| TJ202 | Experimental | Not described Receives: Drug: TJ202 and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)
Measured: end of study [ Time Frame: Approximately up to 2 years ]
Secondary outcomes (6)
Clinical benefit rate (CBR)
Measured: end of study [ Time Frame: Approximately up to 2 years ]
Duration of response (DOR)
Measured: end of study [ Time Frame: Approximately up to 2 years ]
Time to progression (TTP)
Measured: end of study [ Time Frame: Approximately up to 2 years ]
Time to response (TTR)
Measured: end of study [ Time Frame: Approximately up to 2 years ]
Progression-free survival (PFS)
Measured: end of study [ Time Frame: Approximately up to 2 years ]
Overall survival (OS)
Measured: end of study [ Time Frame: Approximately up to 2 years ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start28 Jan 2019
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- TJ Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Doctor, Principal investigator, Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860038
- Sponsor's protocol ID
- TJ202001MMY201
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2019
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03860038
- Acronym / sponsor ID
- TJ202001MMY201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJ202 | Experimental | Drug: TJ202 and Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ202 and Dexamethasoneone 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. | Drug | TJ202 |
Primary outcome
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)
6 secondary outcomes
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 ]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lugui Qiu, Doctor principal investigator
Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TJ202 and Dexamethasone in people with Multiple Myeloma in Relapse and Refractory Multiple Myeloma, run by TJ Biopharma Co., Ltd. at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: end of study [ Time Frame: Approximately up to 2 years ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.