| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma in Relapse Refractory Multiple Myeloma | Drug: TJ202, Lenalidomide and Dexamethasone Drug: Lenalidomide and Dexamethasone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 291 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 27, 2019 |
| Estimated Primary Completion Date : | July 31, 2022 |
| Estimated Study Completion Date : | July 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: TJ202, Lenalidomide and Dexamethasone |
Drug: TJ202, Lenalidomide and Dexamethasone
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.
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| Active Comparator: Lenalidomide and Dexamethasone |
Drug: Lenalidomide and Dexamethasone
Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Liang Wang, Master | 021-60575731 | liang.wang@i-mabbiopharma.com |
Show 42 study locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 16, 2019 | ||||
| Last Update Posted Date | April 5, 2021 | ||||
| Actual Study Start Date ICMJE | March 27, 2019 | ||||
| Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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 | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
291 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 31, 2022 | ||||
| Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China, Taiwan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03952091 | ||||
| Other Study ID Numbers ICMJE | TJ202001MMY301 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | I-Mab Biopharma Co. Ltd. | ||||
| Study Sponsor ICMJE | I-Mab Biopharma Co. Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | I-Mab Biopharma Co. Ltd. | ||||
| Verification Date | April 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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