protocolSection identificationModule nctId: NCT06348108, orgStudyIdInfo id: 232514, secondaryIdInfos id: NCI-2024-01992, type: REGISTRY, domain: NCI Clinical Trials Reporting Program, briefTitle: Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Thomas Martin, MD, class: OTHER, collaborators name: Bristol-Myers Squibb, collaborators name: Janssen Research & Development, LLC, descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is approved for use by the Food and Drug Administration (FDA) to treat RRMM when given alone. Talquetamab can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain types of cancer including myeloma. Giving talquetamab in combination with iberdomide and dexamethasone may be safe, tolerable and effective in treating patients with RRMM, conditionsModule conditions: Multiple Myeloma, conditions: Refractory Multiple Myeloma, conditions: Relapsed Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Talquetamab, interventions name: Iberdomide, interventions name: Dexamethasone, interventions name: Bone Marrow Biopsy, outcomesModule primaryOutcomes measure: Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts), primaryOutcomes measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts), primaryOutcomes measure: Recommended phase 2 dose (RP2D) (Dose Escalation Cohorts), primaryOutcomes measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort), primaryOutcomes measure: Objective response rate (ORR) (Dose Expansion Cohort), secondaryOutcomes measure: Objective response rate (ORR) (Dose Escalation Cohorts), secondaryOutcomes measure: Number of participants achieving VGPR or CR and MRD (negative (-)) response, secondaryOutcomes measure: Proportion of participants with treatment-related adverse events, secondaryOutcomes measure: Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time, secondaryOutcomes measure: Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Calfornia, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Kenya Gomez, role: CONTACT, email: Kenya.Gomez@ucsf.edu, contacts role: CONTACT, phone: 877-827-3222, email: cancertrials@ucsf.edu, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False