Trial | NCT04287660  Report issue

Title

Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
A Phase 3, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of Clarithromycin(Biaxin)-Lenalidomide-Low-Dose-Dexamethasone (BiRd) Combined With B-cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Newly Diagnosed Multiple Myeloma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    20
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
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.
Study Started
Oct 19
2017
Primary Completion
Jan 31
2023
Anticipated
Study Completion
Jan 31
2025
Anticipated
Last Update
Oct 25
2021

Drug clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells [clarithromycin (biaxin), lenalidomide (revlimid), dexamethasone, ciltacabtagene autoleucel (Carvykti)]

clarithromycin: 500mg, PO, twice daily, on days 1~21 for a 28-day cycle. lenalidomide: 25mg, PO, on days 1~21 for a 28-day cycle. dexamethasone: 40mg, PO on days 1,8,15 and 22 for a 28-day cycle. BCMA CAR T cell: (2-3)×10E7/kg, intravenously infusion. Doses should be adjusted according to renal function.

BiRd combined with BCMA CAR T-cells infusion Experimental

Criteria 

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.
No Results Posted