2023-505053-40-00CompletedPhase 2
Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 16 May 2023
- Start date
- 30 Nov 2023
- Lead sponsor
- Lillebaelt Hospital
- Diseases
- Multiple myeloma
- EU CT number
- 2023-505053-40-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Hyperviscosity syndrome
Lab values
- 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)
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet | Copenhagen Oe | Denmark | Completed |
| Region Midtjylland | Herning | Denmark | Completed |
| Odense University Hospital | Odense C | Denmark | Completed |
| Sygehus Lillebaelt - Vejle Sygehus | Vejle | Denmark | Completed |
| North Estonia Medical Centre Foundation | Tallinn | Estonia | Completed |
| Oslo University Hospital HF | Oslo | Norway | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.