Multiple Myeloma in RelapsePhase 3NCT03952091
TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 3 study testing TJ202, Lenalidomide and Dexamethasone and Lenalidomide and Dexamethasone in people with Multiple Myeloma in Relapse and Refractory Multiple Myeloma, run by TJ Biopharma Co., Ltd. at 41 sites in 2 countries.
Trial summary
A phase 3, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in subjects with relapsed or refractory multiple myeloma who received at least 1 prior line 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, Lenalidomide and Dexamethasone and Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 27 Mar 2019to 30 Jun 2024
- Phase
- Phase 3
- 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;
- Subjects must have had documented MM;
- At the screening phase, subject must have one or more measurable disease;
- Subjects must have received at least 1 prior line treatment* for relapsed or refractor MM;
- Subjects who are in a state of progressive disease (PD);
- Subjects must have life expectancy of no less than 6 months;
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- Subjects must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;
- A woman of child-bearing potential must have a negative serum pregnancy test within 14 days prior to the first study agent administration, and a negative urine pregnancy test on the day of the first study agent administration; as well as those should avoid sexual intercourse with the opposite sex or should adopt two reliable methods of contraception at the same time during the study period. A woman of child-bearing potential is required to take effective contraceptive measures throughout this study and within 6 months after the last dosing; female subjects must agree not to donate any eggs for the purpose of assisted reproduction throughout this study and within 6 months after completion of this study;
- Male subjects who are sexually active with women of child-bearing potential and have not undergone vasoligation must agree to use barrier methods of birth control, or that their partners use block caps (cervical cap or dome cap), spermicidal foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, or suppository, and all male subjects are not allowed to donate sperms throughout this study and within 6 months after the last dosing;
- Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study;
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
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's disease shows evidence of resistance to lenalidomide;
- Subject's disease shows evidence of intolerance to lenalidomide;
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- Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM;
- Subjects with known moderate or severe persistent asthma within the past 5 years;
- Subject has active hepatitis B or C virus infection15. Subject is seropositive for human immunodeficiency virus (HIV);
- Subject has clinically significant cardiac disease;
- Subject has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products;
- Subject with known or suspicious conditions that would lead to failure to abide by the study protocol.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
China40 sites
Capital Medical University (CMU) - Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
Capital Medical University (CMU) - Beijing Chao-Yang Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Bengbu Medical college
Bengbu, Bengbu
Fujian Medical University Union Hospital
Fujian, Fuzhou, 350001
Sun Yat-Sen University Cancer Center
Guangdong, Guangzhou, 510060
Guangdong General Hospital
Guangdong, Guangzhou, 510080
Guangzhou First People's Hospital
Guangdong, Guangzhou, 510180
Nanfang Hospital
Guangdong, Guangzhou, 510515
Shenzhen Second Hospital
Guangdong, Shenzhen, 518035
Guangxi Medical Univ. 1st Hospital
Guangxi, Nanning, 530021
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Henan Cancer Hospital
Henan, Zhengzhou, 450008
The Central Hospital Of Wuhan
Hubei, Wuhan, 430014
Hunan Cancer Hospital
Hunan, Changsha
Second Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, 330006
The First Bethune Hospital of Jilin University
Jilin City, Changchun, 130021
The First Hospital of Lanzhou University
Lanzhou, Lanzhou, 730000
Lanzhou University Second Hospital
Lanzhou, Lanzhou, 730030
Nanjing Drum Tower Hospital
Nanjing, Nanjing, 210008
Jiangsu Province Hospital
Nanjing, Nanjing, 210029
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200000
Shanghai Jiao Tong University School of Medicine - Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
The First Hospital of China Medical University
Shenyang, Shenyang, 110001
The First Affiliated Hospital of Soochow University
Suzhou, Suzhou, 215006
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Taiwan, Kaohsiung, 833
National Taiwan University Hospital
Taiwan, Taibei, 100
Taichung Veterans General Hospital
Taiwan, Taichung, 40705
Tri-Service General Hospital
Taiwan, Taipei, 114
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Hubei Cancer Hospital
Wuhan, Hubei
The second affiliated hospital of Kunming medical university
Yunnan, Kunming, 650101
The First People's Hospital of Yunnan Province
Yunnan, Kunming, 650221
The First Affiliated Hospital of Zhejiang University
Zhejiang, Hangzhou, 310003
The First Affiliated Hospital of Zhejiang University
Zhejiang, Hangzhou
The First Affiliated Hospital of Wenzhou Medical University
Zhejiang, Wenzhou, 325000
About this study
Official title: A Phase 3, Randomized, Open-label, Parallel-controlled, Multi-center Study Comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 1 Prior Line of Treatment
A phase 3, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in subjects with relapsed or refractory multiple myeloma who received at least 1 prior line of treatment
- Being tested
- TJ202, Lenalidomide and Dexamethasone, Lenalidomide 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, Lenalidomide and DexamethasoneDrug
One dose of TJ202 will be given on Day 1 and Day 4 of Week 1, respectively, every week from Week 2 to Week 12, every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter.Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
Lenalidomide and DexamethasoneDrug
Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.
| Study group | Role | What they receive |
|---|---|---|
| TJ202, Lenalidomide and Dexamethasone | Experimental | Not described Receives: Drug: TJ202, Lenalidomide and Dexamethasone |
| Lenalidomide and Dexamethasone | Active comparator | Not described Receives: Drug: Lenalidomide and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first
Measured: 18.4 months(Active) 30.7 months(experimental)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start27 Mar 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- TJ Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952091
- Sponsor's protocol ID
- TJ202001MMY301
- Status last verified
- Jul 2024
- First submitted
- 14 May 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He H, Shang J, Wang Y, Xia Z, Zhu F, Yang Y, Fang B, Chen W, Chen B, Cai Z, Zhou H, Li Y, Liu H, Chen L, Liu Y, Huang Z, Zeng P, Jin J, Li Y, Mi J, Zhou Z, Gao S, Xi Y, Wang Q, Chang C, Du X, Huang SY, Wang HY, Ko PS, Shao Z, Luo J, Wang S, Huang J, Dai M, Yang T, Zhan R, Liang B, Wang MC, Wu S, Zhong L, Wei Y, Wang H, Wu H, Li J, Teng CL, Meng Y, Wu M, Yang P, Chen X, Zhu AX, Fu W, Wu D, Fu C. Felzartamab plus lenalidomide-dexamethasone versus lenalidomide-dexamethasone for relapsed or refractory multiple myeloma: an open-label, parallel-controlled, randomised, phase 3 trial. Lancet Haematol. 2026 Oct;13(10):e722-e736. doi: 10.1016/S2352-3026(26)00223-1.
PubMed 42822478
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label, Parallel-controlled, Multi-center Study Comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 1 Prior Line of Treatment
- ClinicalTrials.gov ID
- NCT03952091
- Acronym / sponsor ID
- TJ202001MMY301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 16 May 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.
A phase 3, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in subjects with relapsed or refractory multiple myeloma who received at least 1 prior line of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TJ202, Lenalidomide and Dexamethasone | Experimental | Drug: TJ202, Lenalidomide and Dexamethasone |
| Lenalidomide and Dexamethasone | Active comparator | Drug: Lenalidomide and Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18, male or female;
- Subjects must have had documented MM;
- At the screening phase, subject must have one or more measurable disease;
- Subjects must have received at least 1 prior line treatment* for relapsed or refractor MM;
- Subjects who are in a state of progressive disease (PD);
Key exclusion criteria (12 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's disease shows evidence of resistance to lenalidomide;
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, Lenalidomide and DexamethasoneOne dose of TJ202 will be given on Day 1 and Day 4 of Week 1, respectively, every week from Week 2 to Week 12, every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter.Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter. | Drug | TJ202, Lenalidomide and Dexamethasone |
| Lenalidomide and DexamethasoneLenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered. | Drug | Lenalidomide and Dexamethasone |
Primary outcome
Progression-free survival (PFS)
Time frame: 18.4 months(Active) 30.7 months(experimental)
defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first
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 3 Jul 2024.
- Derived from this study: PubMed 42822478He H, Shang J, Wang Y, Xia Z, Zhu F, Yang Y, Fang B, Chen W, Chen B, Cai Z, Zhou H, Li Y, Liu H, Chen L, Liu Y, Huang Z, Zeng P, Jin J, Li Y, Mi J, Zhou Z, Gao S, Xi Y, Wang Q, Chang C, Du X, Huang SY, Wang HY, Ko PS, Shao Z, Luo J, Wang S, Huang J, Dai M, Yang T, Zhan R, Liang B, Wang MC, Wu S, Zhong L, Wei Y, Wang H, Wu H, Li J, Teng CL, Meng Y, Wu M, Yang P, Chen X, Zhu AX, Fu W, Wu D, Fu C. Felzartamab plus lenalidomide-dexamethasone versus lenalidomide-dexamethasone for relapsed or refractory multiple myeloma: an open-label, parallel-controlled, randomised, phase 3 trial. Lancet Haematol. 2026 Oct;13(10):e722-e736. doi: 10.1016/S2352-3026(26)00223-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TJ202, Lenalidomide and Dexamethasone and Lenalidomide and Dexamethasone in people with Multiple Myeloma in Relapse and Refractory Multiple Myeloma, run by TJ Biopharma Co., Ltd. at 41 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 11 inclusion and 12 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-free survival (PFS) (time frame: 18.4 months(Active) 30.7 months(experimental)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952091, which also lists 1 linked publication.
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 3 Jul 2024.