drugset / Trial / NCT04923893
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
Timeline
- Start
- 2021-08-19
- Primary completion
- 2029-02-14
- Completion
- 2036-09-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ciltacabtagene autoleucel | Cell therapy | 750000 cells/kg | — |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |