protocolSection identificationModule nctId: NCT06352866, orgStudyIdInfo id: CASE3A23, briefTitle: Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jack Khouri, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion., conditionsModule conditions: Multiple Myeloma, conditions: Cytokine Release Syndrome, conditions: Refractory Multiple Myeloma, conditions: Immune Effector Cell Associated Neurotoxicity Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study is an open label single cohort feasibility and efficacy study of siltuximab prophylaxis prior to infusion of teclistamab for treatment of RRMM. There is no planned dose escalation and no separate cohorts.Participants will receive a single dose of prophylactic siltuximab, 11 mg/kg, 2 hours prior to the administration of the first dose of teclistamab on day 1. There is no planned dose escalation of siltuximab, and teclistamab dosing will be done following the standard planned ramp-up. Participants will be hospitalized for 9 days according to teclistamab package insert and Cleveland Clinic institutional practice. Participants will be followed for the incidence of CRS and ICANS for the first two 22-day cycles of treatment., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Siltuximab, interventions name: Teclistamab(FDA-approved), outcomesModule primaryOutcomes measure: Change in CRS Rate, secondaryOutcomes measure: Safety assessment of a single dose of siltuximab as CRS prophylaxis, secondaryOutcomes measure: Incidence of grade ≥ 2 cytokine release syndrome after siltuximab prophylaxis, secondaryOutcomes measure: Incidence of all grade ICANS after siltuximab prophylaxis, secondaryOutcomes measure: Incidence of adverse events after siltuximab prophylaxis, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Hospitalization rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Jack Khouri, MD, role: CONTACT, phone: 866-223-8100, email: TaussigResearch@ccf.org, contacts name: Jack Khouri, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False