Maintenance Therapy After Stem Cell Transplantation: Iberdomid Versus Lenalidomide in Newly Diagnosed Multiple Myeloma

Multiple myeloma is a cancer that affects certain immune cells, known as plasma cells, in the bone marrow. It can lead to anemia, bone pain, and kidney damage. The exact cause is unknown. It is typically treated with a combination of different medications to suppress the cancer to the point where an autologous stem cell transplant is possible. This is followed by maintenance therapy, which is intended to stabilize the response and prevent a relapse. Lenalidomide is frequently used as maintenance therapy following a successful autologous stem cell transplant. Iberdomid (also known as CC-220) and lenalidomide are immunomodulatory agents, meaning they act directly on cancer cells and stimulate the immune system to fight them.

The goal of this Phase 3 study is to investigate the efficacy and safety of Iberdomid compared to Lenalidomide as maintenance therapy following a stem cell transplant. To this end, patients will be randomly assigned to receive either Iberdomid (at one of three tested doses; the final dose will be determined in advance during an initial phase of the study) or lenalidomide. The study is an international, open-label (unblinded) Phase 3 trial, meaning that both patients and the study team know which treatment is being administered. The most important criterion is how long the disease remains stable (progression-free survival) over a period of 6 years. Additional objectives include assessing quality of life, side effects, achievement of “minimal residual disease” (MRD) negativity, and overall survival (follow-up for up to 12 years).

Women and men aged 18 and older with confirmed, symptomatic multiple myeloma are eligible to participate. A prerequisite is that the patient has already received 3 to 6 cycles of standard prior therapy consisting of a proteasome inhibitor and an immunomodulatory agent (often combined with an anti-CD38 antibody), followed by one or two autologous stem cell transplants; additional consolidation therapy is permitted. Enrollment is possible if the disease has responded to treatment (at least a partial response) and the start of prior therapy occurred no more than 12 months ago (for one transplant) or 15 months ago (for two transplants).