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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04287660
• Other study ID #: BiRd-01
• Status: Recruiting
• Phase: Phase 3
• Start date: October 19, 2017
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: Xiaowen Tang, Ph.D
• Phone: 86-512677801856
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (14)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Soochow University

Affiliated Hospital of Jiangnan University, Changshu Frist People's Hospital, Huai'an Second People's Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Jiangyin People's Hospital, Jingjiang People's Hospital, Lianyungang Hospital Affiliated Bengbu Medical College, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, Suzhou Municipal Hospital, The first Affiliated Hospital of Nanjing University Medical School, The First Affiliated Hospital with Nanjing Medical University, The Third People's Hospital of Kunshan, Zhangjiagang First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	ORR includes stringent complete response (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR). Stringent complete response (sCR): complete response as defined below plus normal free light chain (FLC) and absence of clonal cells in bone marrow biopsy by immunohistochemistry (?/? ratio =4:1 or =1:2 for ? and ? patients, respectively, after counting =100 plasma cells). Complete Response (CR):negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Very good partial response (VGPR):serum and urine M-protein detectable by immunofixation but not on electrophoresis or =90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 h. Partial response (PR): =50% reduction of serum M-protein plus reduction in 24 h urine M-protein by =90% or to <200 mg per 24 h.	4 weeks after CAR T-cells infusion (up to 14 weeks)
Secondary	Overall survival (OS)	time from enrollment to the date of death from any cause	4 years
Secondary	Event-free survival (EFS)	time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause	4 years
Secondary	Cumulative incidence of relapse(CIR)	time from the date of achievement of a remission until the date of relapse	4 years
Secondary	Number of adverse events	adverse events are evaluated with CTCAE V5.0	2 years