RecruitingPhase 2NCT06793449

BCMA CAR-T Versus ASCT in Transplant-eligible Patients With Multiple Myeloma

A Prospective, Non-inferiority Study Comparing VRD±D Followed by BCMA CAR-T Cell Therapy Versus VRD±D Followed by Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly-diagnosed Multiple Myeloma


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

80 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, non-inferiority study comparing VRD±D followed by BCMA CAR-T cell therapy versus VRD±D followed by autologous hematopoietic stem cell transplantation in the treatment of newly diagnosed multiple myeloma patients.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for newly diagnosed multiple myeloma patients who are fit enough for a stem cell transplant: the traditional autologous stem cell transplant (using the patient's own stem cells) versus a newer CAR-T cell therapy targeting a protein called BCMA on myeloma cells. **You may be eligible if...** - You are 18–70 years old with newly diagnosed multiple myeloma - You have measurable disease that can be tracked with blood or urine tests - Your myeloma cells have the BCMA protein - Your doctor considers you healthy enough for a stem cell transplant **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal cord - You have plasma cell leukemia or amyloidosis - You have previously received CAR-T therapy or BCMA-targeted treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALanti-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.

BIOLOGICALASCT

Autologous stem cell infusion


Locations(1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

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NCT06793449


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