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临床试验/NCT04287660
NCT04287660招募中3 期

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

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月19日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Overall response rate (ORR)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)
  • 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

排除标准

  • 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.

研究组 & 干预措施

BiRd combined with BCMA CAR T-cells infusion

Experimental

干预措施: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells (Drug)

结局指标

主要结局

Overall response rate (ORR)

时间窗: 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.

次要结局

  • Event-free survival (EFS)(4 years)
  • Overall survival (OS)(4 years)
  • Cumulative incidence of relapse(CIR)(4 years)
  • Number of adverse events(2 years)

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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