search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring BiRd, CART, BCMA, MM

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BiRd combined with BCMA CAR T-cells infusion

Arm Description

Outcomes

Primary Outcome Measures

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 (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ 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.

Secondary Outcome Measures

Overall survival (OS)
time from enrollment to the date of death from any cause
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
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse
Number of adverse events
adverse events are evaluated with CTCAE V5.0

Full Information

First Posted
February 19, 2020
Last Updated
October 22, 2021
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Changshu Frist People's Hospital, The Second People's Hospital of Huai'an, Affiliated Hospital of Jiangnan University, Jiangsu Province Hospital of Traditional Chinese Medicine, Jiangyin People's Hospital, Jingjiang People's Hospital, The Third People's Hospital of Kunshan, Lianyungang Hospital Affiliated Bengbu Medical College, Suzhou Municipal Hospital, Zhangjiagang First People's Hospital, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, The First Affiliated Hospital with Nanjing Medical University, The first Affiliated Hospital of Nanjing University Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT04287660
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
BiRd, CART, BCMA, MM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BiRd combined with BCMA CAR T-cells infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
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 (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ 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.
Time Frame
4 weeks after CAR T-cells infusion (up to 14 weeks)
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
time from enrollment to the date of death from any cause
Time Frame
4 years
Title
Event-free survival (EFS)
Description
time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause
Time Frame
4 years
Title
Cumulative incidence of relapse(CIR)
Description
time from the date of achievement of a remission until the date of relapse
Time Frame
4 years
Title
Number of adverse events
Description
adverse events are evaluated with CTCAE V5.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Tang, Ph.D
Phone
86-512677801856
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Depei Wu, Ph.D
Phone
86-512677801856
Email
drwudepei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D
Phone
86-512677801856
Email
xwtang1020@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs