CTIS2023-505053-40-00RecruitingPhase 1
Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD
illebaelt Hospital0 sites100 target enrollmentStarted: May 16, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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
Investigators
Similar Trials
Active, not recruiting
Phase 1
Early immunotherapy with intravenous immunoglobulin, cyclophosphamide and methylprednisolone in patients with anti-Hu-associated paraneoplastic sensory neuropathy (NESPA).paraneoplastic sensory neuropathy with anti-Hu antibodiesMedDRA version: 20.0Level: PTClassification code: 10072106Term: Paraneoplastic neurological syndrome Class: 100000004852CTIS2023-506942-22-01Assistance Publique Hopitaux De Paris21
Active, not recruiting
Not Applicable
ndersøgelse af subcutan immunglobulin behandling af patienter med multifokal motorisk neuropatiMultifokal motor neuropathyEUCTR2005-000934-19-DKeurologisk Afdeling Århus Universitetshospital20
Active, not recruiting
Phase 1
Early treatment with intravenous immunoglobulins for newly diagnosed myositis patientsEUCTR2016-004766-26-NLAcademic Medical Center20
Completed
Phase 2
Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.myositisNL-OMON46904Academisch Medisch Centrum20
Completed
Not Applicable
IMMEDIATE study- idiopathic inflammatory myopathies- myositis (practical/clinical synonym)- auto-immune disease- neuromuscular diseaseNL-OMON25293Department of Neurology, Academic Medical Center Amsterdam20