NCT05860036

A Study of VRd-based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With New-diagnosed Multiple Myeloma

Safety and Efficiency of VRd-based Regimen Followed by BCMA CAR-T for New-diagnosed Transplant-ineligible Multiple Myeloma Patients: a Prospective, Single-arm, Single-center, Phase II Study.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRd(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma

Detailed description

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of treatment with VRd (Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma. Patients received 3 courses of induction therapy with VRd-based regimen followed by infusion of BCMA CAR-T cells. Patients then received 3 courses of VR-based consolidation therapy, followed by R maintenance therapy.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	anti-BCMA CAR-T	Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg.
DRUG	VRd	Bortezomib, Lenalidomide and Dexamethasone

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-06-01
• Completion: 2028-03-10
• First posted: 2023-05-16
• Last updated: 2025-08-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study