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

Last updated: October 22, 2021
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

3

Condition

Platelet Disorders

Leukemia

Cancer

Treatment

N/A

Clinical Study ID

NCT04287660
BiRd-01
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Patients are pregnant or lactating.
  2. Nonsecretory MM.
  3. History of previous treatment of MM.
  4. Patients with uncontrolled active infection.
  5. Patients with active hepatitis B or hepatitis C infection.
  6. Patients with HIV infection.
  7. Patients with atrial or venous thrombosis or embolism.
  8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
  9. Other comorbidities that investigators considered not suitable for this study.

Study Design

Total Participants: 20
Study Start date:
October 19, 2017
Estimated Completion Date:
January 31, 2025

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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