NCT03952091

TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma in Relapse
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-03-27
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2019-05-16
• Last updated: 2024-07-03

Locations

41 sites across 2 countries: China, Taiwan