nctId: NCT06348108 id: 232514 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 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2028-06-30 date: 2024-04-04 date: 2024-04-04 name: Thomas Martin, MD class: OTHER name: Bristol-Myers Squibb name: Janssen Research & Development, LLC 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 conditions: Multiple Myeloma conditions: Refractory Multiple Myeloma conditions: Relapsed Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Talquetamab name: Iberdomide name: Dexamethasone name: Bone Marrow Biopsy measure: Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts) measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts) measure: Recommended phase 2 dose (RP2D) (Dose Escalation Cohorts) measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort) measure: Objective response rate (ORR) (Dose Expansion Cohort) measure: Objective response rate (ORR) (Dose Escalation Cohorts) measure: Number of participants achieving VGPR or CR and MRD (negative (-)) response measure: Proportion of participants with treatment-related adverse events measure: Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time measure: Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Calfornia, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Kenya Gomez role: CONTACT email: Kenya.Gomez@ucsf.edu role: CONTACT phone: 877-827-3222 email: cancertrials@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False