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临床试验/NCT03619252
NCT03619252已完成4 期

Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Incidence of clinically/radiologically confirmed pneumonia and episodes of febrile neutropenia during one year period after initiation of novel agents.

研究概览

简要总结

Multiple myeloma is an incurable blood cancer of plasma cells that occurs in older individuals. Novel agents (proteasome inhibitors, immunomodulatory agents) have substantially improved the overall response rates, progression-free survival and overall survival in patients with multiple myeloma. Patients with multiple myeloma are at high risk of developing life-threatening Streptococcus pneumoniae infections, while clinical efficacy and safety of conjugate pneumococcal vaccines in multiple myeloma patients receiving novel agents have not been studied before. The main aim of this study is to assess the clinical efficacy and safety of 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents.

详细描述

Multiple myeloma is an incurable blood cancer of plasma cells that occurs in older individuals with a median age at diagnosis of 69 years and a median overall survival of 6-7 years [Kumar S.K., et al. Leukemia, 2014; Rollig C., et al. Lancet., 2015]. Over the past years novel agents have been introduced into clinical practice, showing improved overall response rates, progression-free survival and overall survival in patients with multiple myeloma. The main classes of novel agents include proteasome inhibitors, immunomodulatory agents and monoclonal antibodies. These agents are typically used in doublet or triplet regimens that include a chemotherapeutic drug and/or corticosteroid.

Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality. Patients with multiple myeloma are at high risk of developing life-threatening Streptococcus pneumoniae infections due to chemotherapy-associated immunosuppression. Vaccination is an important preventive strategy against infections caused by S. pneumoniae. In the past, the 23-valent pneumococcal polysaccharide vaccine was recommended. However, polysaccharide vaccines have limited efficacy in cancer and hematology patients, because of the decreased T- and B-cell responses. Clinical efficacy and safety of conjugate pneumococcal vaccines in multiple myeloma patients receiving novel agents have not been studied before.

In this study the investigators wish to study the effect of vaccination with 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents (proteasome inhibitors and immunomodulatory drugs). The main aim of this study is to assess the clinical efficacy and safety of 13-valent pneumococcal conjugate vaccine in multiple myeloma patients treated with novel agents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with proven diagnosis of multiple myeloma
  • Patients must be enrolled in treatment with novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab)
  • Patients must have Creatinine Clearance above 30 mL/min on the Day 1 of trial
  • Patients must have given informed consent to participate in trial.

排除标准

  • Contraindication to the use of one of the study drug/vaccines (including known hypersensitivity)
  • Creatinine Clearance below 30 mL/min on the Day 1 of trial
  • Psychiatric disorder or unable to understand or to follow the protocol directions
  • Active bacterial, viral, fungal or protozoal infection on the Day 1 of trial

研究组 & 干预措施

Vaccination group

Experimental

Patients receiving novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab) and enrolled in vaccination by pneumococcal conjugate vaccine (PCV13): 3 doses with 1 month interval, and fourth dose planned to be administered 6 months later.

干预措施: Vaccination with pneumococcal conjugate vaccine (PCV13) (Biological)

Standard prophylaxis

Active Comparator

Patients receiving novel agents (Bortezomib/Lenalidomide/Ixazomib/Daratumumab) and receiving standard institutional antibacterial prophylaxis by Levofloxacin 500 mg daily during the median four cycles of treatment by novel agents

干预措施: Standard Antibacterial Prophylaxis (Drug)

结局指标

主要结局

Incidence of clinically/radiologically confirmed pneumonia and episodes of febrile neutropenia during one year period after initiation of novel agents.

时间窗: One year

次要结局

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.(One year)

研究者

发起方
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ihar Iskrou

Head of Cell Transplant Division

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

研究点 (1)

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