Study on Selinexor, Venetoclax, and Dexamethasone for Treating Relapsed or Refractory Multiple Myeloma with t(11;14) Mutation
Sponsor: University of Miami
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT05530421
This clinical trial is testing a combination of three drugs—selinexor, venetoclax, and dexamethasone—to see if they can improve treatment outcomes for patients with a specific type of multiple myeloma that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The aim of this study is to find out if a combination of the drugs selinexor, venetoclax, and dexamethasone can enhance the anti-cancer effects in patients with a specific genetic mutation (t(11;14)) in their multiple myeloma, which has either come back after treatment or has not responded to previous therapies.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of multiple myeloma with specific criteria, such as certain levels of proteins in the blood or bone marrow, or specific symptoms like anemia or bone lesions.
- Must have a specific genetic mutation called t(11;14) in their myeloma cells, confirmed by a lab test.
- Must have relapsed or refractory multiple myeloma, meaning the cancer has returned or not responded to at least two previous treatments.
- Must have measurable disease based on specific medical guidelines.
- Must be 18 years or older.
- Must have a performance status that allows for daily activities with some limitations.
- Must have adequate organ function based on specific blood test results.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
- Must be willing to provide informed consent and comply with study procedures.
Exclusion Criteria
- Have previously received selinexor or similar drugs.
- Have any medical condition that could interfere with the study, such as uncontrolled high blood pressure or diabetes.
- Have an active infection requiring treatment within a week before starting the study.
- Have an allergy or intolerance to steroids.
- Are pregnant or breastfeeding.
- Have unstable heart conditions or recent heart attack.
- Have active hepatitis B or untreated hepatitis C, unless under specific conditions.
- Have difficulty swallowing pills or any condition affecting drug absorption.
- Are unable or unwilling to take supportive medications for nausea or appetite.
- Have any serious psychiatric or medical conditions that could interfere with the study.
- Have any contraindications to the study drugs or required treatments.
- Are unable or unwilling to comply with the study protocol.
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