Phase 2 Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone Combination and Iberdomide Alone for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are studying a combination of iberdomide, carfilzomib, daratumumab, and dexamethasone Iber-KDd to see if it works better than current treatments for patients with relapsed or refractory multiple myeloma MM. This phase 2 study aims to evaluate how well this combination shrinks or prevents the return of MM and how tolerable it is for patients. The trial is led by Dr. Benjamin T Diamond and focuses on patients who have already received prior therapies. Participants will receive up to eight 28-day cycles of the Iber-KDd combination therapy, including pre-treatment with acetaminophen, diphenhydramine, and montelukast. Iberdomide is given orally daily for 21 days each cycle, carfilzomib intravenously on specific days, daratumumab either subcutaneously or intravenously on scheduled days, and dexamethasone orally or intravenously at varying doses during the cycles. After these cycles, patients without disease progression will continue with up to twelve 28-day cycles of iberdomide alone. The total study participation can last up to five years, including follow-up after treatment. During the study, participants will be regularly monitored for response, including the rate of minimal residual disease MRD negativity, treatment-related toxicity, overall response rates, and survival outcomes. Assessments include blood and urine tests for disease markers, kidney and liver function, and performance status. Safety is closely tracked, and participants will be followed for up to three years after finishing therapy. The study evaluates both the combination therapy and subsequent iberdomide monotherapy to understand their effects over time.

Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma