NCT05177536

Iberdomide Maintenance Therapy in Patients With Multiple Myeloma

Phase 2 Study of Iberdomide Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lenalidomide maintenance therapy following autologous stem cell transplant (ASCT) is standard of care for patients with multiple myeloma. However, nearly all patients will experience disease relapse and lenalidomide's toxicity profile leads to treatment discontinuation in 30% of patients after one year. Iberdomide is a novel potent cereblon E3 ligase modulator with a favorable side effect profile. Investigators hypothesize that iberdomide maintenance therapy may result in at least 80% of subjects completing one year of maintenance. This study will determine the feasibility, safety and efficacy of iberdomide maintenance therapy post-autologous stem cell transplant (ASCT). Around day 100 after ASCT, patients will be assessed to determine study eligibility. Enrolled participants will take iberdomide pills by mouth on days 1-21 of each 28 day cycle. Physical exams, well-being status and blood and/or urine sampling will be conducted and evaluated before each cycle. Treatment will continue until disease progression or toxicity. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun.The results from this study will inform the feasibility of pursuing a study comparing iberdomide to lenalidomide maintenance post-ASCT.

Detailed description

Lenalidomide maintenance therapy following autologous stem cell transplant (ASCT) is standard of care for patients with multiple myeloma. However, nearly all patients will experience disease relapse and lenalidomide's toxicity profile leads to treatment discontinuation in 30% of patients after one year. Iberdomide is a novel potent cereblon E3 ligase modulator with a favorable side effect profile. Investigators hypothesize that iberdomide maintenance therapy may result in at least 80% of subjects completing one year of maintenance. This is a phase II study to determine the feasibility, safety and efficacy of iberdomide maintenance therapy post-autologous stem cell transplant (ASCT). Around day 100 after ASCT, patients will be assessed to determine study eligibility. Prior to each 28 day cycle, enrolled participants will have health evaluations, well-being assessment and lab tests. Blood and/or urine will be collected for routine tests, disease status and drug effects. Participants will take iberdomide pills by mouth at 1.0 mg PO daily on days 1-21 of each cycle. Treatment will continue until disease progression or toxicity. Participants on study drug at year 1 \& 2 will have bone marrow biopsies to assess the disease. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun. Study objectives include determination of the proportion of participant completing one year of maintenance treatment, median progression free survival (PFS), minimal residual disease (MRD)-negativity rate at one year post-study drug initiation, sustained MRD-negativity rate, rate of conversion from MRD-positive to negative; overall survival (OS); and safety profile. The results from this study will inform the feasibility of pursuing a phase 3 study comparing iberdomide to lenalidomide maintenance post-ASCT.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Iberdomide	Iberdomide is a novel potent cereblon E3 ligase modulator

Timeline

• Start date: 2022-04-15
• Primary completion: 2026-01-01
• Completion: 2031-01-01
• First posted: 2022-01-04
• Last updated: 2025-05-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study