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

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.

Locations

FACILITYZIPCITYSTATE
University of Miami, Lennar Foundation Medical Center33146Coral GablesFlorida
University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach33442Deerfield BeachFlorida
University of Miami, Sylvester Comprehensive Cancer Center33136MiamiFlorida

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