drugset / Trial / NCT05257083
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
Phase 3
Active not recruiting
759 enrolled
Stichting European Myeloma Network
Janssen Research & Development, LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
Timeline
- Start
- 2023-10-10
- Primary completion
- 2033-06
- Completion
- 2040-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ciltacabtagene autoleucel | Cell therapy | 750000 cells/kg | Intravenous |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |