drugset / Trial / NCT05054478

Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation

NCT05054478 ↗

Phase 2 Not yet recruiting 29 enrolled Assistance Publique - Hôpitaux de Paris
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

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 1800 mg Subcutaneous

Indications