CTIS2023-505053-40-00招募中1 期
Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD
illebaelt Hospital0 个研究点目标入组 100 人开始时间: 2023年5月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
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/
排除标准
- •Prior systemic therapy for multiple myeloma (inclusion will be allowed within 30 days from initiation of systemic therapy for multiple myeloma), Pregnancy, 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
研究者
相似试验
进行中(未招募)
1 期
Early immunotherapy with intravenous immunoglobulin, cyclophosphamide and methylprednisolone in patients with anti-Hu-associated paraneoplastic sensory neuropathy (NESPA).paraneoplastic sensory neuropathy with anti-Hu antibodiesMedDRA version: 20.0Level: PTClassification code: 10072106Term: Paraneoplastic neurological syndrome Class: 100000004852CTIS2023-506942-22-01Assistance Publique Hopitaux De Paris21
进行中(未招募)
不适用
ndersøgelse af subcutan immunglobulin behandling af patienter med multifokal motorisk neuropatiMultifokal motor neuropathyEUCTR2005-000934-19-DKeurologisk Afdeling Århus Universitetshospital20
进行中(未招募)
1 期
Early treatment with intravenous immunoglobulins for newly diagnosed myositis patientsEUCTR2016-004766-26-NLAcademic Medical Center20
已完成
2 期
Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.myositisNL-OMON46904Academisch Medisch Centrum20
已完成
不适用
IMMEDIATE study- idiopathic inflammatory myopathies- myositis (practical/clinical synonym)- auto-immune disease- neuromuscular diseaseNL-OMON25293Department of Neurology, Academic Medical Center Amsterdam20
