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

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04287660
Collaborator
Changshu Frist People's Hospital (Other), The Second People's Hospital of Huai'an (Other), Affiliated Hospital of Jiangnan University (Other), Jiangsu Province Hospital of Traditional Chinese Medicine (Other), Jiangyin People's Hospital (Other), Jingjiang People's Hospital (Other), The Third People's Hospital of Kunshan (Other), Lianyungang Hospital Affiliated Bengbu Medical College (Other), Suzhou Municipal Hospital (Other), Zhangjiagang First People's Hospital (Other), Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd (Industry), The First Affiliated Hospital with Nanjing Medical University (Other), The first Affiliated Hospital of Nanjing University Medical School (Other)
20
1
1
87.4
0.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 19, 2017
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BiRd combined with BCMA CAR T-cells infusion

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.

Outcome Measures

Primary Outcome Measures

  1. Overall response rate (ORR) [4 weeks after CAR T-cells infusion (up to 14 weeks)]

    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

  1. Overall survival (OS) [4 years]

    time from enrollment to the date of death from any cause

  2. Event-free survival (EFS) [4 years]

    time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause

  3. Cumulative incidence of relapse(CIR) [4 years]

    time from the date of achievement of a remission until the date of relapse

  4. Number of adverse events [2 years]

    adverse events are evaluated with CTCAE V5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006

Sponsors and Collaborators

  • The First Affiliated Hospital of Soochow University
  • 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

Investigators

  • Principal Investigator: Xiaowen Tang, Ph.D, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT04287660
Other Study ID Numbers:
  • BiRd-01
First Posted:
Feb 27, 2020
Last Update Posted:
Oct 25, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The First Affiliated Hospital of Soochow University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021