Study of Iberdomide Alone or with Dexamethasone in Adults with Intermediate- or High-Risk Smoldering Multiple Myeloma Phase 2 Clinical Trial to Evaluate Treatment Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the effects of iberdomide alone or combined with dexamethasone in patients with intermediate- or high-risk smoldering multiple myeloma, a condition where abnormal plasma cells are present but symptoms have not yet developed. This phase II study aims to understand how these treatments may impact the immune system and potentially slow the progression to symptomatic myeloma while monitoring their safety and tolerability. Participants are randomly assigned to one of two groups. One group receives oral iberdomide daily on days 1 to 21 of a 28-day cycle along with dexamethasone on days 1, 8, 15, and 22 for four cycles, followed by iberdomide alone in the same dosing schedule. The other group receives only oral iberdomide daily on days 1 to 21 of each 28-day cycle. Treatments continue unless the disease progresses or side effects become unacceptable. During the study, participants undergo regular assessments to track their response to treatment, including overall response rate, progression-free survival, time to disease progression, and overall survival. Safety is monitored by recording adverse events, and specific tests evaluate blood cell counts, organ function, and stem cell mobilization. After the treatment period, patients have a follow-up visit four weeks later and then every six months to monitor their health and disease status.

Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma