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

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.

Inclusion Criteria:

1. Be informed and voluntarily sign the Informed Consent Form (ICF).
2. Age between 18 and 70 years (inclusive).
3. Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L.
4. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry.
5. Assessed by the investigator as transplant-eligible.

Exclusion Criteria:

1. Primary plasma cell leukemia.
2. Concurrent amyloidosis.
3. Involvement of the central nervous system (CNS).
4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.