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

Phase 2

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Biological: ASCT; Biological: anti-BCMA CAR-T

• Registration Number: NCT06793449
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASCT	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.
BCMA CAR-T	anti-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.

Primary Outcome Measures

Name	Time	Method
Persistent MRD-negative rate	Up to 2 year	achieving MRD-negative, as determined by NGS/NGF
Progression free survival (PFS)	Up to 5 year	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

Secondary Outcome Measures

Name	Time	Method
Duration of Remission(DOR)	Up to 5 year	Duration from the first evaluation of at least partial remission (PR) to the onset of disease progression or death due to disease progression (whichever occurs first)
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	CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria
Overall Survival (OS)	Up to 5 year	Overall survival is measured from the date of diagnosis to the date of the participant's death.

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China