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

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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