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NCT Number: NCT06793449

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tianjin, China

Location status: Recruiting

Location contact

Gang An, PhD&MD

CONTACT

[email protected]

008613502181109

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

ASCT

Biological

Autologous stem cell infusion

Primary outcomes

  1. Persistent MRD-negative rate

    Time frame: Up to 2 year

    achieving MRD-negative, as determined by NGS/NGF

  2. Progression free survival (PFS)

    Time frame: 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 outcomes

  1. 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

    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

  2. Duration of Remission(DOR)

    Time frame: 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)

  3. Overall Survival (OS)

    Time frame: Up to 5 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gang An, PhD&MD

CONTACT

[email protected]

86-022-23909171

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Acronym: CAREMM-006

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Jan 27, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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