RecruitingPhase 2NCT05530421

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

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


Sponsor

University of Miami

Enrollment

33 participants

Start Date

Mar 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — selinexor, venetoclax, and dexamethasone — in people with relapsed or treatment-resistant multiple myeloma that has a specific chromosomal change called t(11;14), which makes venetoclax potentially more effective. **You may be eligible if...** - You are 18 or older with confirmed multiple myeloma - Your myeloma cells have the t(11;14) chromosomal translocation (confirmed by a certified lab test) - You have received at least 2 prior lines of therapy, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody - Your disease has relapsed or is refractory (not responding) to these prior treatments **You may NOT be eligible if...** - Your myeloma does NOT have the t(11;14) translocation - You have not received the required prior lines of therapy - You have severe organ dysfunction or other health conditions that make these drugs unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor

Selinexor tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.

DRUGVenetoclax

Venetoclax tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.

DRUGDexamethasone

Dexamethasone tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.


Locations(3)

University of Miami, Lennar Foundation Medical Center

Coral Gables, Florida, United States

University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT05530421