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Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD
EU CTIS ID: 2023-505053-40-00
What this study is testing
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.)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Prior systemic therapy for multiple myeloma (screening 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.