drugset / Trial / NCT05054478
Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation
NaSingle-groupOpen-labelTreatment
Summary
Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1 year.
Timeline
- Start
- 2021-10
- Primary completion
- 2024-06
- Completion
- 2028-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |