Phase III Study of Iberdomide, Belantamab Mafodotin, and Dexamethasone Combination Compared to Belantamab Mafodotin and Dexamethasone in Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety, side effects, best dose, and effectiveness of iberdomide combined with belantamab mafodotin and dexamethasone in patients with relapsed or refractory multiple myeloma. Multiple myeloma is a cancer affecting plasma cells in the bone marrow, which have a protein called BCMA that helps the cancer cells grow. This trial aims to see if this combination treatment can slow or stop the cancers growth and improve survival compared to treatment without iberdomide. In the first phase, patients receive iberdomide orally on specific days, belantamab mafodotin intravenously on day 1, and dexamethasone orally on multiple days in each 56-day cycle. The second phase randomizes patients into two groups one receiving belantamab mafodotin and dexamethasone, and the other receiving the combination including iberdomide. Treatment cycles repeat every 56 days unless the disease progresses or side effects become unacceptable. Patients may cross over to the combination group if their disease worsens. Participants undergo various tests including echocardiography, CT, MRI, and PET scans during screening and as needed. Bone marrow biopsies and blood samples are collected throughout the trial. After treatment, patients are followed every six months for up to three years. Researchers monitor progression-free survival, overall survival, treatment responses, side effects, immune cell changes, and disease markers to assess the treatments impact and safety.

Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma