Clinical trial NCT04287660: Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: BiRd
CART
BCMA
MM
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Changshu Frist People's Hospital
name: The Second People's Hospital of Huai'an
name: Affiliated Hospital of Jiangnan University
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Jiangyin People's Hospital
name: Jingjiang People's Hospital
name: The Third People's Hospital of Kunshan
name: Lianyungang Hospital Affiliated Bengbu Medical College
name: Suzhou Municipal Hospital
name: Zhangjiagang First People's Hospital
name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
name: The First Affiliated Hospital with Nanjing Medical University
name: Nanjing Medical University
First posted: 2020-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 newly diagnosed MM patients. The study participation will be 4 years including treatment and follow-up periods.

Eligibility criteria: 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 grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL

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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 4 weeks after CAR T-cells infusion (up to 14 weeks)
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 4 years
measure: Event-free survival (EFS)
timeFrame: 4 years
measure: Cumulative incidence of relapse(CIR)
timeFrame: 4 years
measure: Number of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Xiaowen Tang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: