Status:
UNKNOWN
Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Changshu Frist People's Hospital
The Second People's Hospital of Huai'an
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04287660
Start Date
October 19 2017
End Date
January 31 2025
Last Update
October 25 2021
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006