Phase III Study of Elotuzumab, Iberdomide, and Dexamethasone After Idecabtagene Vicleucel in Adults with Relapsed and Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the use of Elotuzumab and Iberdomide therapy following Idecabtagene Vicleucel treatment in adults with relapsed and refractory multiple myeloma. This phase III, open-label, non-randomized study aims to assess the effectiveness and safety of this combination, with Elotuzumab and dexamethasone already approved for multiple myeloma, while Iberdomide is still under investigation. The study is supported by Bristol-Myers Squibb and Celgene, providing the study drugs and funding. Participants will receive study treatment through a dose escalation phase followed by a dose expansion phase. Treatment involves cycles of Iberdomide taken orally daily for 21 days, alongside dexamethasone and Elotuzumab given on specific days within each 28-day cycle. The dose escalation phase determines the maximum tolerated dose of Iberdomide, starting at Dose Level 0 and increasing to Dose Level 1. After treatment concludes, participants have a follow-up visit at 14 days and regular follow-ups every 28 days for up to two years. During the study, participants undergo various assessments including bone marrow biopsies, blood and urine tests, ECGs, X-rays, and imaging scans such as PET, CT, or MRI. Researchers monitor treatment effects, side effects, and disease progression through measures like dose limiting toxicities, maximum tolerated dose, and progression-free survival at 12 months. Secondary outcomes include evaluating minimal residual disease, time to progression, response duration, overall survival, and treatment-related toxicities. Participants are expected to be involved in study visits and evaluations from treatment start through follow-up periods lasting up to four years.

Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM