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    DRUG:

    Sylvant (siltuximab)

    i
    Other names: CNTO 328, cCLB8, CNTO-328
    Company:
    BeOne Medicines, Jazz
    Drug class:
    IL-6 inhibitor
    Related drugs:
    21d
    Early intervention for high-risk smoldering multiple myeloma (SMM). (PubMed, Cochrane Database Syst Rev)
    Early intervention with daratumumab may reduce the risk of disease progression and mortality in people with high-risk SMM. The evidence on the risk of adverse events with daratumumab is very uncertain. For immunomodulatory agents, the available evidence is of very low certainty, partly due to conflicting results, so we are unable to draw conclusions about their effects. There is insufficient evidence to support the use of older agents like alkylating agents or cytokine inhibitors. The decision to initiate early treatment in high-risk SMM requires a careful, individualized risk-benefit assessment and shared decision-making.
    Clinical • Review • Journal
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    CD40LG (CD40 ligand)
    |
    lenalidomide • Darzalex (daratumumab) • prednisone • thalidomide • melphalan • Sylvant (siltuximab)
    1m
    Case Report: Targeted interleukin-6 blockade by siltuximab for cytokine release syndrome control and infection limitation in thirteen patients treated with bi-specific T-cell engagers. (PubMed, Front Immunol)
    This approach was associated with only three grade 1-2 infections, indicating a favorable safety profile. These preliminary results support the design of a prospective multicenter study to evaluate the feasibility of home-based BiTE administration, integrating point-of-care testing, a digital health platform, and 24/7 remote monitoring via a dedicated call center, within a comprehensive medico-economic framework.
    Clinical • Journal
    |
    IL6 (Interleukin 6) • CRP (C-reactive protein)
    |
    Sylvant (siltuximab)
    2ms
    20240178: Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide versus Durvalumab, Carboplatin, and Etoposide in First-Line ES-SCLC (DeLLphi-312) (2024-520050-38-00)
    P2/3, N=129, Recruiting, Amgen Inc.
    New P2/3 trial
    |
    carboplatin • Imfinzi (durvalumab) • etoposide IV • Imdelltra (tarlatamab-dlle) • Sylvant (siltuximab)
    2ms
    20230239: Phase 3 Study of Xaluritamig Plus Abiraterone vs Investigator's Choice in Chemotherapy-nave Metastatic Castration-resistant Prostate Cancer (2025-520555-89-00)
    P2/3, N=295, Recruiting, Amgen Inc.
    New P2/3 trial
    |
    docetaxel • abiraterone acetate • cabazitaxel • Sylvant (siltuximab) • xaluritamig (AMG 509)
    4ms
    Siltux-AMR: A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation (clinicaltrials.gov)
    P1, N=30, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carfilzomib • Sylvant (siltuximab)
    5ms
    Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Sylvant (siltuximab)
    5ms
    Screening Trial for Pain Relief in Schwannomatosis (STARFISH) (clinicaltrials.gov)
    P2, N=40, Recruiting, Massachusetts General Hospital | Trial primary completion date: Mar 2026 --> Nov 2026
    Trial primary completion date
    |
    Sylvant (siltuximab)
    6ms
    Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease (clinicaltrials.gov)
    P2, N=14, Recruiting, University of Pennsylvania | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Jakafi (ruxolitinib) • Sylvant (siltuximab)
    7ms
    Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, University of Alabama at Birmingham | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Sylvant (siltuximab)
    8ms
    The Evolution and Recent Advances in Diagnostic Criteria for Idiopathic Multicentric Castleman Disease. (PubMed, Am J Hematol)
    Key drivers of iMCD pathogenesis, such as interleukin-6 dysregulation and other dysfunctional cytokine signaling, have been identified and led to the development of targeted therapies like siltuximab and tocilizumab. Emerging technologies, including single-cell sequencing, spatial transcriptomics, and digital pathology, offer promise in refining diagnostic precision and advancing personalized medicine. This review synthesizes historical frameworks, recent breakthroughs, and future directions in iMCD diagnostics, emphasizing the importance of multidisciplinary approaches for improved patient outcomes.
    Review • Journal
    |
    IL6 (Interleukin 6)
    |
    Actemra IV (tocilizumab) • Sylvant (siltuximab)
    8ms
    Siltuximab in Large Granular Lymphocytic Leukemia (LGLL) (clinicaltrials.gov)
    P1, N=6, Terminated, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2027 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2026 --> Oct 2024; lack of efficacy/futility
    Trial completion date • Trial termination • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • B3GAT1 (Beta-1,3-Glucuronyltransferase 1)
    |
    Sylvant (siltuximab)
    8ms
    Sirolimus in Previously Treated Idiopathic Multicentric Castleman Disease (clinicaltrials.gov)
    P2, N=7, Active, not recruiting, University of Pennsylvania | Trial completion date: Jun 2025 --> Jun 2026
    Trial completion date
    |
    sirolimus • Sylvant (siltuximab)