Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD
Key facts
- Where
- Copenhagen Oe, Herning, Odense C és Vejle, DániaSee the 4 sites
- Phase
- 2. fázis
Where in Dánia
- RigshospitaletCopenhagen Oe, DániaNo longer taking part
- Region MidtjyllandHerning, DániaNo longer taking part
- Odense University HospitalOdense C, DániaNo longer taking part
- Sygehus Lillebaelt - Vejle SygehusVejle, DániaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lillebaelt Hospital
- Trial code
- EU 2023-505053-40-00
- Record updated
- 2026. március 10.
- Original description
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.)Read full original descriptionShow less
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.)
Inclusion: 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.
Exclusion: Prior systemic therapy for multiple myeloma (screening will be allowed within 30 days from initiation of systemic therapy for multiple myeloma); 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; 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); Pregnancy.