Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05530421

Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma

Led by University of Miami · Updated on 2026-02-23

33

Participants Needed

3

Research Sites

365 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

K

Karyopharm Therapeutics Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this research is to determine whether the combination of selinexor, venetoclax, and dexamethasone therapy can increase anti-cancer effects in patients with translocation 11;14-positive (t(11;14)), relapsed/refractory myeloma (RRMM).

CONDITIONS

Official Title

Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with multiple myeloma according to International Myeloma Working Group criteria
  • Bone marrow biopsy confirming t(11;14) translocation by certified lab test
  • Relapsed or refractory multiple myeloma after at least two prior therapies
  • Refractory to, ineligible for, or intolerant of at least one immunomodulatory drug, one proteasome inhibitor, and one anti-CD38 antibody
  • Measurable disease by IMWG guidelines within 4 weeks before registration
  • Age 18 years or older at time of consent
  • ECOG performance status of 3 or less
  • Adequate organ function shown by lab tests within 4 weeks before treatment
  • Negative pregnancy test for women of childbearing potential
  • Use of effective contraception during study and for 90 days after last dose
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment with selinexor or another nuclear export inhibitor
  • Any active medical condition likely to interfere with study procedures
  • Uncontrolled active infection needing intravenous antibiotics, antivirals, or antifungals within 1 week before treatment
  • Known intolerance or allergy to glucocorticoids
  • Pregnant or breastfeeding women
  • Unstable heart conditions including symptomatic ischemia, severe heart failure, or recent heart attack
  • Active hepatitis B without adequate antiviral therapy or uncontrolled hepatitis C
  • Active gastrointestinal problems affecting swallowing or absorption of tablets
  • Unable or unwilling to take recommended supportive medications for nausea or anorexia
  • Serious psychiatric or medical conditions that could affect treatment or consent
  • Contraindications to required concomitant drugs
  • Inability or unwillingness to comply with study protocol or cooperate with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Miami, Lennar Foundation Medical Center

Coral Gables, Florida, United States, 33146

Actively Recruiting

2

University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States, 33442

Actively Recruiting

3

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

A

Alanna Vossen

CONTACT

D

Dickran Kazandjian, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma | DecenTrialz