Phase Ib/II Fixed Duration Study of Teclistamab/Pomalidomide (TP) Versus Carfilzomib/Pomalidomide/Dexamethasone (KPd) in Early Relapse of Multiple Myeloma
National Cancer Institute (NCI)
Summary
This phase Ib/II trial compares the effect of teclistamab and pomalidomide to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Carfilzomib blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. It is a type of proteasome inhibitor. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving teclistamab and pomalidomide may be safe, tolerable and improve response by lowering myeloma cells to undetectable levels when compared to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with relapsed multiple myeloma.
Description
PRIMARY OBJECTIVES: I. To evaluate the toxicity of teclistamab and pomalidomide (TP) combination therapy in multiple myeloma (MM) patients in early relapse after one or two lines of therapy and establish the pomalidomide dose to be used with teclistamab in the Phase II portion of the trial. (Phase Ib) II. To determine whether patients with MM in early relapse after one or two lines of therapy who are randomized to teclistamab and pomalidomide (TP) compared to carfilzomib, pomalidomide, and dexamethasone (KPd) have superior efficacy measured by minimal residual disease (MRD)-negative complete…