Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 19 February 2024
dexamethasone
ejection fraction
multiple myeloma
lenalidomide
clarithromycin
cellular therapy
bcma
car t-cell therapy

Summary

The purpose of this study is to evaluate the safety and efficacy of BiRd regimen combined with BCMA CAR T cell therapy in newly diagnosed multiple myeloma patients

Description

This is a phase 3, single arm, multi-center study. The patients will receive BiRd regimen (clarithromycin,lenalidomide, dexamethasone) combined with infusion of autologous BCMA-directed CAR T-cells in newly diagnosed MM patients. The study participation will be 4 years including treatment and follow-up periods.

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age 18-75 years
Treatment clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
Clinical Study IdentifierNCT04287660
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)
Age 18-75
Eastern Cooperative Oncology Group (ECOG) score 0-2
BCMA positive as detected with flowcytometry or ELISA
Patients with left ventricular ejection fraction 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification
Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL

Exclusion Criteria

Patients are pregnant or lactating
Nonsecretory MM
History of previous treatment of MM
Patients with uncontrolled active infection
Patients with active hepatitis B or hepatitis C infection
Patients with HIV infection
Patients with atrial or venous thrombosis or embolism
Patients with myo-infarction or severe arrythmia in the recent 6 months
Other comorbidities that investigators considered not suitable for this study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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