A Study of VRd-based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With New-diagnosed Multiple Myeloma
NCT05860036 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-08-03
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
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-04
- Primary Completion
- 2025-06-01
- Completion
- 2028-03-10
- FDA Drug
- Yes
Countries
- China
Study Locations
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