A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT05560399
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Iberdomide, Elotuzumab and Dexamethasone Dexamethasone Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase). Iberdomide, Elotuzumab and Dexamethasone Elotuzumab Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase). Iberdomide, Elotuzumab and Dexamethasone Iberdomide Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase).
- Primary Outcome Measures
Name Time Method Iberdomide dose limiting toxicity 28 days The dose limiting toxicity (DLT) rate at the Maximum Tolerated Dose, defined as the proportion of patients in the safety population of the study that experience at least 1 DLT within the first cycle of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone treated at the maximum tolerated dose (MTD).
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) up to 3 months PFS: is defined as the duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier
Number of adverse events (AE) up to 3 months Number of Adverse Events (AE) - an AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Best Overall Response Rate (BOR) up to 3 months Best Overall Response Rate (BOR) is defined as the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved sCR, CR, VGPR, PR, minimal response, and Stable Disease (SD), according to IMWG criteria at any evaluation assessment prior to progression of disease as their best response.
Overall Response Rate (ORR) up to 3 months Overall Response Rate (ORR) is defined as the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved best overall response of PR or better (Stringent Complete Response (sCR); Complete Response (CR); Very good partial response (VGPR); Partial Response (PR), according to International Myeloma Working Group (IMWG) criteria at Cycle 4 Day 1 (C4D1).
Clinical Benefit Rate up to 3 months Clinical Benefit Rate is the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved best overall response of minimal response or better (sCR + CR + VGPR + PR + minimal response \[MR\]) according to the IMWG criteria at C4D1
Duration of Response (DOR) up to 3 months Duration of Response (DOR) is defined as the time from achieving a PR or better to progression, per 2016 IMWG criteria
Overall Survival (OS) up to 3 months Overall survival is defined from time from initiation of treatment to death by any cause
Disease Control Rate up to 3 months Disease Control Rate is the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved best overall response of stable disease or better (sCR + CR + VGPR + PR + MR + SD) according to the IMWG criteria at C4D1
Trial Locations
- Locations (1)
Icahn School of Medicine
🇺🇸New York, New York, United States