Phase II Study of VRD Regimen Combined with BCMA CAR-T Therapy for Adults 18 to 75 Years Old with Primary Plasma Cell Leukemia Ineligible for Transplant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment involving a VRD-based regimen and BCMA CAR-T therapy for patients with primary plasma cell leukemia who are not eligible for transplant. This phase II, single-arm, open-label study aims to assess outcomes in this specific patient group at a single center, focusing on key measures such as safety and the rate of minimal residual disease negativity after consolidation treatment. Participants receive three courses of induction therapy with the VRD-based regimen, consisting of Bortezomib, Lenalidomide, and Dexamethasone administered in a 28-day cycle. This is followed by an intravenous infusion of autologous BCMA-directed CAR-T cells at a targeted dose. After the CAR-T infusion, patients undergo three courses of VR consolidation therapy and then continue with VR maintenance therapy. Throughout the study, participants will be closely monitored with evaluations including safety and tolerability assessments up to two years, and measurement of minimal residual disease negativity shortly after consolidation therapy. Additional outcomes include complete response rates at various time points, progression-free survival up to two years, overall survival up to five years, and duration of remission. The total study duration and follow-up periods allow for comprehensive assessment of treatment effects and patient outcomes.

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia