Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD

Phase 1

Recruiting

• Conditions: Multiple Myeloma; MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2023-505053-40-00
• Lead Sponsor: illebaelt Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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/

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.);Secondary Objective: To measure the burden of infections in the study population, To measure quality of life in the study population, To identify blood tests that predict increased susceptibility to infections;Primary end point(s): 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 2 or higher.)