RecruitingPhase 1NCT05981209

Elotuzumab, CC-92480, and Dexamethasone for the Treatment of Relapsed or Refractory Myeloma After CD38- and BCMA-Targeted Therapies

Phase 1b Study to Assess Safety and Efficacy of Elotuzumab, CC-92480, and Dexamethasone in Relapsed/Refractory Myeloma After CD38- and BCMA-Targeted Therapies


Sponsor

Abdullah Khan

Enrollment

27 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial tests the safety, side effects, and best dose of CC-92480 in combination with elotuzumab and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment or has not responded to previous treatment (refractory). Multiple myeloma (MM) remains the second most common hematologic malignancy in the United States. A number of therapies have been approved for patients with MM, including CD38- and B-cell maturating antigen (BCMA)-targeted therapies (antibody and plasma cell treatments that help the body's immune system to kill cancer cells); however, patients will often relapse and become refractory to these therapies. Because of this, it is important to identify effective treatment options for patients progressing on anti-CD38 therapy and BCMA-directed therapies. Elotuzumab is a humanized IgG1 monoclonal antibody, which is a type of protein that can bind to other target cells to prevent them from working the way they should or cause them to act differently. Elotuzumab works by targeting a protein called SLAMF7, which is present on myeloma cells, and makes it easier for the immune system to target the cancer. CC-92480 works by binding to a protein called CRBN that triggers the breakdown of proteins: Ikaros and Aiolos, leading to cell death in multiple myeloma cells. Dexamethasone is a synthetic adrenocortical steroid, or steroid normally naturally made by the adrenal gland in the brain which has been produced in a laboratory, that helps to regulate the amount of different chemicals and water that are being processed by the kidneys. It is also used in patients with myeloma to help treat their disease. The combination of CC-92480 with elotuzumab and dexamethasone may be a safe and effective treatment when given to patients with relapsed or recurrent MM.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — elotuzumab, CC-92480, and dexamethasone — for people with multiple myeloma (a cancer of plasma cells) whose cancer has stopped responding to multiple previous treatments, including therapies targeting CD38 and BCMA. **You may be eligible if:** - You are 18 or older with relapsed or refractory multiple myeloma - You have received at least 2 prior treatment regimens, including lenalidomide, a proteasome inhibitor, an anti-CD38 antibody, and a BCMA-targeted therapy - Your blood counts and organ function meet minimum requirements (hemoglobin ≥7 g/dL, adequate platelet and neutrophil counts, normal liver and kidney function) **You may NOT be eligible if:** - Your myeloma progressed as its best response on prior elotuzumab (or less than 6 months have passed since elotuzumab treatment) - You have serious heart problems (ejection fraction below 30%) - You have uncontrolled active infections or autoimmune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDUREComputed Tomography

Undergo CT

DRUGDexamethasone

Given IV or PO

PROCEDUREEchocardiography

Undergo ECHO

BIOLOGICALElotuzumab

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALMezigdomide

Given PO

PROCEDUREX-Ray Imaging

Undergo x-ray imaging


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05981209


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