BCMA CAR-T Versus ASCT in Transplant-eligible Patients With Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: anti-BCMA CAR-T, ASCT.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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. - Biological ASCT
Autologous stem cell infusion
Primary outcome measures
- Persistent MRD-negative rate [Time frame: Up to 2 year]
- Progression free survival (PFS) [Time frame: Up to 5 year]
Secondary outcome measures (3)
- Complete response rate (CRR) [Time frame: within 1 week after induction therapy, 1 month after the CAR-T cell infusion or ASCT, within 1 week after consolidation therapy]
- Duration of Remission(DOR) [Time frame: Up to 5 year]
- Overall Survival (OS) [Time frame: Up to 5 year]
Eligibility criteria
Inclusion criteria
- Be informed and voluntarily sign the Informed Consent Form (ICF).
- Age between 18 and 70 years (inclusive).
- 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.
- Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry.
- Assessed by the investigator as transplant-eligible.
Exclusion criteria
- Primary plasma cell leukemia.
- Concurrent amyloidosis.
- Involvement of the central nervous system (CNS).
- Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT06793449 · IIT2024104