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

Start 30 Nov 2023 · Status Ongoing, recruitment ended · 3 EU/EEA countries · 6 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruitment ended

Participants planned 100

Countries 3

Sites 6

Multiple Myeloma

Key facts

Sponsor: Lillebaelt Hospital
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration: 30 Nov 2023 → ongoing
Decision date (initial): 2023-09-08
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Takeda

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

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 objectives 3

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

Conditions and MedDRA coding

Multiple Myeloma

Version	Level	Code	Term	System organ class
21.0	LLT	10028228	Multiple myeloma	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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 criteria 5

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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.)

Secondary endpoints 18

Number of days on systemic antibiotic therapy for the treatment of infections (not prophylaxis)
Number of days on systemic antiviral or antifungal therapy for the treatment of infections (not prophylaxis)
Number of days admitted to hospital due to infections
Number of days on intravenous antibiotic treatment
Time to first severe infection
Time to second severe infection
Number, type, and severity of microbiologically defined infections
Number of blood culture days
Overall survival 6 and 12 months after randomization
Infection-related mortality 6 and 12 months after randomization
Serum non-monoclonal IgG trough levels at 3, 6, 9 and 12 months after randomization
Susceptibility to infections depending on M-protein isotype
Susceptibility to infections based on response to anti-myeloma treatment
Patient reported outcome assessment on health-related quality of life
Susceptibility to infections depending on serum anti-pneumococcal polysaccharide IgG antibody levels
Susceptibility to infections depending on peripheral blood CD4+ lymphocyte counts
Susceptibility to infections depending on estimated serum non-monoclonal IgG levels by Hevylite assay
Susceptibility to infections depending on serum IgG subclass deficiency

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

HyQvia 100 mg/ml solution for infusion for subcutaneous use

PRD3644450 · Product

Active substance: Human Normal Immunoglobulin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 50 g gram(s)
Max total dose: 515 g gram(s)
Max treatment duration: 52 Week(s)
Authorisation status: Authorised
ATC code: J06BA01 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.
Marketing authorisation: EU/1/13/840/001
MA holder: BAXALTA INNOVATIONS GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Lillebaelt Hospital

Sponsor organisation: Lillebaelt Hospital
Address: Beriderbakken 4
City: Vejle
Postcode: 7100
Country: Denmark

Scientific contact point

Organisation: Lillebaelt Hospital
Contact name: Agoston Gyula Szabo

Public contact point

Organisation: Lillebaelt Hospital
Contact name: Agoston Gyula Szabo

Third parties 2

Organisation	City, country	Duties
Specific Pharma A/S ORG-100015041	Copenhagen Sv, Denmark	Code 14
Odense University Hospital ORG-100007716	Odense C, Denmark	On site monitoring, E-data capture, Code 8

Locations

3 EU/EEA countries · 6 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ongoing, recruitment ended	70	4
Estonia	Ongoing, recruitment ended	15	1
Norway	Ongoing, recruitment ended	15	1
Rest of world	—	0	—

Investigational sites

Denmark

4 sites · Ongoing, recruitment ended

Rigshospitalet

Hematology, Blegdamsvej 9, 2100, Copenhagen Oe

Region Midtjylland

Hematology, Hospitalsparken 15, 7400, Herning

Odense University Hospital

Hematology, J B Winsloews Vej 4, 5000, Odense C

Sygehus Lillebaelt Vejle Sygehus

Hematology, Kabbeltoft 25, 7100, Vejle

Estonia

1 site · Ongoing, recruitment ended

North Estonia Medical Centre Foundation

Hematology, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn

Norway