drugset / Trial / NCT04287660
Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
Phase 3
Unknown
20 enrolled
The First Affiliated Hospital of Soochow University
Affiliated Hospital of Jiangnan University · collabChangshu Frist People's Hospital · collabJiangsu Province Hospital of Traditional Chinese Medicine · collabJiangyin People's Hospital · collabJingjiang People's Hospital · collabLianyungang Hospital Affiliated Bengbu Medical College · collabNanjing Medical University · collabShanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · collabSuzhou Municipal Hospital · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe Second People's Hospital of Huai'an · collabThe Third People's Hospital of Kunshan · collabZhangjiagang First People's Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of BiRd regimen combined with BCMA CAR T cell therapy in newly diagnosed multiple myeloma patients
Timeline
- Start
- 2017-10-19
- Primary completion
- 2023-01-31
- Completion
- 2025-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clarithromycin | Small molecule | 500 mg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | autologous BCMA-directed CAR T-cells | Cell therapy | 2e+07 cells/kg | Intravenous |
| Subject | autologous BCMA-directed CAR T-cells | Cell therapy | 3e+07 cells/kg | Intravenous |