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A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma — CC-220  

Multiple Myeloma Clinical Trial

Official title:
A Multicenter Phase 1-DEC (Dose Expansion Cohort) Open-label Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Clinical Trial Summary

This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in patients with RRMM. The researchers hypothesize that the combination of Iberdomide and Elotuzumab will synergize to promote myeloma cell death, resulting in an overall response rate of at least 53%, with an acceptable safety profile. Patients will be enrolled in a 3+3 dose escalation cohort to evaluate the safety of this combination and to establish the MTD (maximum tolerated dose). The MTD will be the dose for the patients enrolled in dose expansion cohort. A total maximum of 37 patients will be recruited: maximum 18 patients will be recruited in the dose escalation phase, followed by an additional 19 patients in the dose expansion cohort for a total of 25 patients treated at the MTD.

Clinical Trial Description

Part 1 is an open-label, sequential allocation, dose-finding evaluation of the sequential administration of Iberdomide in combination with Elotuzumab and Dexamethasone at their approved doses for patients with relapsed/refractory multiple myeloma. This phase will follow a standard 3+3 design. During this phase, the maximum tolerated dose of Iberdomide in combination with Elotuzumab and Dexamethasone will be determined and recommended for the dose expansion cohort. Part 2 of this study is an open-label, single-arm dose expansion cohort that will enroll additional patients at the recommended maximum tolerated dose of Iberdomide as determined in Part 1. Researchers will continue to verify the safety and tolerability of this combination and examine the anti-myeloma activity of the regimen. In addition to measuring overall response rate, duration of response, and survival data, researchers will explore the effect of this combination on the biology of multiple myeloma and the immune system in order to gain insight into patterns of response that may help predict patient population most-likely to benefit from this treatment in the future. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05560399
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Enrolling by invitation
Phase Early Phase 1
Start date February 6, 2023
Completion date August 2027
View Details
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