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临床试验/2023-505053-40-00
2023-505053-40-00招募中2 期

Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD

Lillebaelt Hospital6 个研究点 分布在 3 个国家目标入组 100 人开始时间: 2023年9月8日最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
100
试验地点
6
主要终点
The primary endpoint of the study is the annualized incidence of severe infections. (Severe is defined as Common Terminology Criteria for Adverse Events version 5.0 grade 2 or higher.)
研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this study is to assess primary immunoglobulin prophylaxis with HyQvia in transplant-ineligible patients with newly diagnosed multiple myeloma. The study hypothesis is that primary immunoglobulin prophylaxis with HyQvia will reduce the number of infections and early mortality compared to standard of care. The primary endpoint of the study is the annualized incidence of severe infections. (Severe is defined as Common Terminology Criteria for Adverse Events version 5.0 grade of 2 or higher.)

入排标准

年龄范围
18 years 至 65+ years（18-64 Years, 65+ Years）
接受健康志愿者
否

入选标准

  • •Age ≥ 18 years
  • •Able to provide informed consent in accordance with national and institutional guidelines
  • •Newly diagnosed multiple myeloma satisfying the CRAB criteria or with the presence of a biomarker for malignancy based on the International Myeloma Work Group criteria
  • •Ineligible to high-dose melphalan with autologous stem cell transplantation
  • •Hypogammaglobulinemia defined as reduction of at least one uninvolved immunoglobulin below the following concentrations: IgG: 6 g/L; IgA: 0.7 g/L; IgM 0.4 g/L

排除标准

  • •Prior systemic therapy for multiple myeloma (screening will be allowed within 30 days from initiation of systemic therapy for multiple myeloma)
  • •Hyperviscosity syndrome
  • •History of anaphylactic or severe systemic hypersensitivity reaction to any of the following: human immunoglobulin; to human IgA in patients with IgA deficiency; to hyaluronidase including recombinant human hyaluronidase of HyQvia; to human albumin (in the hyaluronidase solution)
  • •Concurrent somatic or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study

结局指标

主要结局

The primary endpoint of the study is the annualized incidence of severe infections. (Severe is defined as Common Terminology Criteria for Adverse Events version 5.0 grade 2 or higher.)

The primary endpoint of the study is the annualized incidence of severe infections. (Severe is defined as Common Terminology Criteria for Adverse Events version 5.0 grade 2 or higher.)

次要结局

  • Number of days on systemic antibiotic therapy for the treatment of infections (not prophylaxis)
  • Number of days on systemic antiviral or antifungal therapy for the treatment of infections (not prophylaxis)
  • Number of days admitted to hospital due to infections
  • Number of days on intravenous antibiotic treatment
  • Time to first severe infection
  • Time to second severe infection
  • Number, type, and severity of microbiologically defined infections
  • Number of blood culture days
  • Overall survival 6 and 12 months after randomization
  • Infection-related mortality 6 and 12 months after randomization
  • Serum non-monoclonal IgG trough levels at 3, 6, 9 and 12 months after randomization
  • Susceptibility to infections depending on M-protein isotype
  • Susceptibility to infections based on response to anti-myeloma treatment
  • Patient reported outcome assessment on health-related quality of life
  • Susceptibility to infections depending on serum anti-pneumococcal polysaccharide IgG antibody levels
  • Susceptibility to infections depending on peripheral blood CD4+ lymphocyte counts
  • Susceptibility to infections depending on estimated serum non-monoclonal IgG levels by Hevylite assay
  • Susceptibility to infections depending on serum IgG subclass deficiency

研究者

发起方
Lillebaelt Hospital
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Agoston Gyula Szabo

Scientific

Lillebaelt Hospital

研究点 (6)

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