NCT05560399

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

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Iberdomide	Route of administration: oral pill. Schedule: Taken Once daily on days 1-21. Dose: will be tested at 1 mg, 1.3 mg, and 1.6mg. 1mg dose may be reduced to 0.75mg if not tolerated.
DRUG	Elotuzumab	Route of administration: IV Dose: 10 mg/kg for cycles 1 and 2. 20 mg/kg for cycle 3 and beyond. Schedule: Days 1, 8, 15, and 22 for cycles 1 and 2. Then taken on Day 1 (every 28 days) of each cycle thereafter.
DRUG	Dexamethasone	Route of administration: Oral pill or IV Dose: 36 mg within 24 hrs of day 1 of each cycle and day 8, 15, and 22 of cycle 1 and 2. 40 mg on days 8, 15, 22 of cycle 3 and all subsequent cycles. (20 mg for \> 75 years old). Schedule: On days that Elotuzumab is administered, Dexamethasone to be taken 28mg orally (for ≤75 years old) or 8mg orally (for \> 75 years old) between 3 and 24 hours before Elotuzumab plus 8 mg IV between 45 and 90 minutes before Elotuzumab for all patients. On days that Elotuzumab is not administered but a dose of Dexamethasone is scheduled (Days 8, 15, and 22 of cycle 3 and all subsequent cycles), 40 mg orally for ≤75 years older and 20 mg for

Timeline

• Start date: 2023-02-06
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2022-09-29
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study