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

NCT06793449 | Recruiting Phase 2

• 1 other identifier: IIT2024104
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Persistent MRD-negative rate

  achieving MRD-negative, as determined by NGS/NGF

  Up to 2 year

• Progression free survival (PFS)

  Progression free survival is defined as the time from the date of diagnosis to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first

  Up to 5 year

Secondary Outcomes (3)

• Complete response rate (CRR)

  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)

  Up to 5 year

• Overall Survival (OS)

  Up to 5 year

Study Arms (2)

ASCT

ACTIVE COMPARATOR

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.

Biological: ASCT

BCMA CAR-T

EXPERIMENTAL

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.

Biological: anti-BCMA CAR-T

Interventions

anti-BCMA CAR-T BIOLOGICAL

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.

BCMA CAR-T

ASCT BIOLOGICAL

Autologous stem cell infusion

ASCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Gang An, PhD&MD

CONTACT

86-022-23909171; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)