A Phase 1b Trial of Teclistamab in Combination With Iberdomide for Relapsed/Refractory Multiple Myeloma
National Cancer Institute (NCI)
Summary
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving iberdomide in combination with teclistamab may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma.
Description
PRIMARY OBJECTIVE: I. Estimate the recommended phase 2 dose (RP2D) of iberdomide in combination with teclistamab. SECONDARY OBJECTIVES: I. To evaluate the safety and toxicity profile of iberdomide in combination with teclistamab. II. To observe and record antitumor activity. CORRELATIVE OBJECTIVES: I. To evaluate the changes in the tumor immune microenvironment (exhausted T-cell phenotypes, percent T regulatory cells \[T regs\], T-cell activation) in peripheral blood and bone marrow caused by the addition of iberdomide to teclistamab and how they relate to minimal residual disease (MRD)…