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

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

Conditions

• Multiple Myeloma

Interventions

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.

Sponsors & Collaborators

• Changshu Frist People's Hospital

  collaborator UNKNOWN

• The Second People's Hospital of Huai'an

  collaborator OTHER

• Affiliated Hospital of Jiangnan University

  collaborator OTHER

• Jiangsu Province Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Jiangyin People's Hospital

  collaborator OTHER

• Jingjiang People's Hospital

  collaborator OTHER

• The Third People's Hospital of Kunshan

  collaborator UNKNOWN

• Lianyungang Hospital Affiliated Bengbu Medical College

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• Zhangjiagang First People's Hospital

  collaborator OTHER

• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

  collaborator INDUSTRY

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  lead OTHER

Principal Investigators

• Xiaowen Tang, Ph.D · The First Affiliated Hospital of Soochow University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-19

Primary Completion

2023-01-31

Completion

2025-01-31

Countries

• China

Study Locations