Study on Mezigdomide, Ixazomib, and Dexamethasone for Treating Relapsed and Refractory Multiple Myeloma
Sponsor: Kathleen Dorritie
ClinicalTrials ID:NCT06050512
This clinical trial is testing a new combination of drugs, Mezigdomide, Ixazomib, and Dexamethasone, to see if they can help treat patients with multiple myeloma that has returned or not responded to previous treatments.
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Program Overview
Multiple myeloma is a type of blood cancer that affects many people each year. Although it is not yet curable, new treatments have greatly improved patient outcomes. This study is exploring a new combination of drugs to see if they can help patients whose multiple myeloma has come back or not responded to other treatments. The study will use a lower starting dose of Ixazomib and Mezigdomide to ensure safety, with regular monitoring for side effects. Dexamethasone will be given at different doses depending on the patient's age and health condition.
Description
Mezigdomide is a new type of drug that helps the body target and destroy multiple myeloma cells. It works by affecting certain proteins in the cancer cells, leading to their death. In earlier studies, Mezigdomide has shown promising results when used with Dexamethasone, and even better results when combined with another drug called Bortezomib. This study aims to see if Mezigdomide, when used with Ixazomib and Dexamethasone, can be an effective treatment for patients with relapsed or refractory multiple myeloma. The study will monitor important outcomes like overall survival and how long patients remain free from disease progression. The goal is to find out if this combination can be a new, effective oral treatment option for these patients.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of less than 2, meaning you are able to carry out all self-care activities but may be unable to carry out any work activities.
- Must have a confirmed diagnosis of multiple myeloma and have received 1-3 previous treatments.
- Must have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody before joining the study.
- Must have measurable signs of multiple myeloma, such as a certain level of M protein in the blood or urine.
- Must have certain blood counts and organ function levels within specified limits.
- Must have access to the drug Ixazomib.
- Women who can become pregnant must have two negative pregnancy tests before starting the study and agree to ongoing pregnancy testing.
- All participants must agree to follow the study's pregnancy prevention plan.
Exclusion Criteria
- Cannot have multiple myeloma that has spread to the central nervous system.
- Cannot have plasma cell leukemia or certain other specific conditions like Waldenstrom's Macroglobulinemia.
- Cannot have been resistant to proteasome inhibitors or have had a bad reaction to Ixazomib.
- Cannot have been previously treated with Mezigdomide.
- Cannot be pregnant or planning to become pregnant.
- Cannot be unwilling to follow the pregnancy prevention plan.
- Cannot be using certain medications that affect the liver or stomach within two weeks of starting the study.
- Cannot have serious heart or lung conditions.
- Cannot have had another cancer within the last two years, except for certain skin cancers.
- Cannot have active infections or certain viral infections like HIV or hepatitis.
- Cannot have had major surgery or radiation therapy recently.
- Cannot have allergies to the study drugs or have severe nerve damage.
- Cannot be participating in another clinical trial or have done so recently.
- Cannot have any medical or psychiatric conditions that would interfere with the study.
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