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

Phase 2RecruitingNCT06793449

Institute of Hematology & Blood Diseases Hospital, China80 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

anti-BCMA CAR-TBIOLOGICAL

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.

ASCTBIOLOGICAL

Autologous stem cell infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Tianjin, China

RECRUITING

Outcomes

Primary Outcomes

Persistent MRD-negative rate

achieving MRD-negative, as determined by NGS/NGF

Time frame: 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

Time frame: Up to 5 year

Secondary Outcomes

Complete response rate (CRR)

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

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)

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)

Time frame: Up to 5 year

Overall Survival (OS)

Overall survival is measured from the date of diagnosis to the date of the participant's death.

Time frame: Up to 5 year

Central Contacts

Gang An, PhD&MD

CONTACT

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

Data from ClinicalTrials.gov

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