Phase 1 Study of Mezigdomide, Talquetamab, and Dexamethasone for Treating Relapsed and Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the combination of mezigdomide and talquetamab, along with dexamethasone, in adults with relapsed and refractory multiple myeloma who have been exposed to three prior lines of therapy including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibodies. This phase 1 open-label study aims to find the recommended dose and schedule of these drugs and to assess their effects on the cancer. The study is estimating treatment duration up to one year or until disease progression or withdrawal. Participants are assigned to one of two cohorts. Cohort A first receives talquetamab with dexamethasone, then a combination of mezigdomide, talquetamab, and dexamethasone. Talquetamab is injected under the skin on specified days within 28-day cycles, while mezigdomide and dexamethasone are taken orally on scheduled days. Cohort B begins after Cohort A and involves a pre-phase with mezigdomide and dexamethasone, followed by treatment with all three drugs in a step-up dosing pattern. Treatment continues until disease progression or participant withdrawal. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, response to treatment, and survival outcomes over an estimated total of three years. The study tracks safety and effectiveness measures such as overall response rate, progression-free survival, and overall survival. Laboratory tests, physical exams, and other evaluations will be performed throughout treatment and follow-up periods to monitor health and treatment effects.

Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma