Phase II Study of Mezigdomide, Carfilzomib, and Dexamethasone for Relapsed or Refractory Multiple Myeloma with Tumors Outside Bone Marrow

What this Trial Is About

Researchers are evaluating a combination treatment of mezigdomide, carfilzomib, and dexamethasone MeziKD for adults with multiple myeloma that has returned after treatment or does not respond to treatment, especially in those with tumors outside the bone marrow extramedullary disease. Mezigdomide works by blocking processes in myeloma cells and may activate immune cells, while carfilzomib blocks enzymes needed for cancer growth. Dexamethasone, a corticosteroid, is also used to kill myeloma cells alongside these drugs. Participants receive mezigdomide orally once daily on days 1 to 21 of each 28-day cycle. Carfilzomib is given intravenously over 30 minutes on days 1, 8, and 15, and dexamethasone is taken orally on days 1, 8, 15, and 22 of each cycle. Treatment continues up to six cycles unless the disease worsens or side effects become unacceptable. Patients responding after six cycles may continue treatment as part of their standard care. Throughout the study, participants undergo various imaging tests like echocardiography, PETCT, MRI, CT-guided tumor biopsy, bone marrow aspiration and biopsy, and blood and saliva sample collection. During the study, researchers assess overall response and clinical benefit rates after six treatment cycles. They also monitor side effects for up to 30 days after the last dose and evaluate how long responses last, progression-free survival, overall survival, and imaging responses for up to three years. These evaluations include regular scans and biopsies to understand treatment effects and disease status. Participants are carefully monitored to ensure safety and treatment adherence during the trial period.

Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease