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: 2024年7月22日

适应症

试验速览

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•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/

•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

发起方

illebaelt Hospital