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
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Gang An, PhD&MD
angang@ihcams.ac.cn
86-022-23909171
Time Frame
Start Date:2025-02-05
Estimated Completion Date:2030-12
Participants
Target number of participants:80
Treatments
Active_comparator: ASCT
Patients will receive 3-4 cycles induction treatment, and high-dose melphalan conditioning, followed by autologous transplantation.Three months post-transplant, patients will undergo 2-3 cycles of consolidation therapy, followed by maintenance therapy for ≥2 years or until disease progression, death, intolerance, withdrawal for other reasons, or the study's termination/completion.
Experimental: BCMA CAR-T
Patients will receives 3-4 cycles of induction therapy, 2-3 cycles of consolidation treatment, followed by Fc-based conditioning and CAR-T cell infusion. One month after CAR-T cell therapy, patients will begin maintenance therapy for ≥2 years or until disease progression, death, intolerance, withdrawal for other reasons, or the study's termination/completion.