Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03952091 | TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma | PHASE3 | COMPLETED | 289 | — | — | Mar 27, 2019 | Jun 30, 2024 | Jul 3, 2024 | 41 | China, Taiwan |
| NCT03860038 | TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma | PHASE2 | COMPLETED | 113 | — | — | Jan 28, 2019 | Jan 28, 2023 | Apr 24, 2025 | 18 | China, Taiwan |
defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first
defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)
| Arm | Type | Description |
|---|---|---|
| TJ202, Lenalidomide and Dexamethasone | EXPERIMENTAL | - |
| Lenalidomide and Dexamethasone | ACTIVE_COMPARATOR | - |
| TJ202 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TJ202, Lenalidomide and Dexamethasone | DRUG | 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 Dexamethasone | DRUG | Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered. |
| TJ202 and Dexamethasone | DRUG | 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. |
Inclusion Criteria: 1. Age ≥ 18, male or female; 2. Subjects must have had documented MM; 3. At the screening phase, subject must have one or more measurable disease; 4. Subjects must have received at least 1 prior line treatment\* for relapsed or refractor MM; 5. Subjects who are in a state of pro...