Study on Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone for Patients with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: Carl Ola Landgren, MD, PhD
ClinicalTrials ID:NCT05896228
This clinical trial is testing a new combination of medications to see if it can improve treatment outcomes for patients with multiple myeloma that has returned or is not responding to current treatments. The study will evaluate how well the combination works and how well patients tolerate it.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if a new combination of drugs—iberdomide, carfilzomib, daratumumab, and dexamethasone—can provide better results for patients with multiple myeloma that has come back or is not responding to standard treatments. Researchers will look at how well this combination can shrink the cancer or stop it from returning, as well as how well patients tolerate the treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma that is getting worse despite treatment or has returned after treatment.
- Have received 1 to 3 previous treatments, including one with lenalidomide, and have measurable disease.
- Previous treatment with CD38-targeted therapy is allowed if it was effective and did not cause progression or side effects leading to discontinuation.
- Previous treatment with carfilzomib is allowed under similar conditions.
- Have good kidney function.
- Be between 18 and 75 years old.
- Be in good overall health with a performance status score of 0 to 2.
- Have adequate blood cell counts and liver function.
- Be able to tolerate blood clot prevention medications.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control. Men must agree to use condoms during sexual activity.
Exclusion Criteria
- Currently receiving other treatments for multiple myeloma, with some exceptions for certain conditions.
- Have not responded to previous CD38-targeted therapy.
- Have plasma cell leukemia, POEMS syndrome, or amyloidosis.
- Have severe lung disease or uncontrolled high blood pressure or diabetes.
- Have active hepatitis B or C infections or HIV.
- Have significant heart disease or recent heart attack.
- Have severe nerve damage or gastrointestinal issues that affect medication absorption.
- Have uncontrolled illnesses or psychiatric conditions that affect study participation.
- Have had major surgery recently or plan to become pregnant or father a child during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33136 | Miami | Florida |
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