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OpenTrials
Active, Not Recruiting

NCT Number: NCT06452446

Telehealth-based Symptom Management for Veterans Treated With Selinexor

The purpose of this study is to find out if continued monitoring of side effects from Selinexor and prescribed medication to prevent side effects helps improve symptoms, quality of life, and ability to continue the treatment longer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

The primary objective of this study is to evaluate control of treatment-related and cancer-associated symptoms over the first three months of therapy with selinexor in Veterans who participate in a telehealth symptom management intervention.

The secondary objectives are:

  • To describe characteristics of patients treated with selinexor.
  • To describe adherence with the telehealth intervention.
  • To define the type and frequency of adverse events that patients experience while taking selinexor.
  • To describe the duration of selinexor therapy and evaluate adherence and dose intensity of selinexor in VA cancer patients receiving a telehealth symptom management intervention.
  • To describe concomitant medication usage in patients treated with selinexor.
  • To assess quality of life in patients treated with selinexor in the VA.
  • To estimate progression-free survival in VA cancer patients treated with selinexor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of B-cell malignancy: either relapsed or refractory multiple myeloma or diffuse large B-cell lymphoma, meeting the FDA-approved indication for Selinexor treatment.
  • Requiring therapy as assessed by the treating oncology provider.
  • Prior authorization drug request for selinexor approved by VA oncology pharmacist.
  • Subject age 18 years or older.
  • Subject willing and able to perform video or telephone research visits.
  • Subjects must be able to read and comprehend English.
  • Subject must be a Veteran receiving cancer care from a VA facility affiliated with the National Teleoncology Program.
  • Patients must be enrolled prior to starting Selinexor.

Exclusion criteria

  • Any prior or current therapy with selinexor.
  • Any medical, psychiatric, or cognitive issue that the principal investigator or the subject's oncologists believes would prevent participation or completion of the study.
  • Individuals who are vulnerable to coercion or undue influence.
  • Any individuals or populations that may temporarily or permanently require additional considerations include such as those susceptible to coercion or undue influence (e.g., patients with limited or no treatment options, socially and economically disadvantaged persons).
  • Current selinexor therapy that is part of an investigational clinical trial.

Treatment and study plan

Selinexor

Drug

Selinexor is an oral therapy that is FDA approved for multiple myeloma and diffuse large B-cell lymphoma that have returned after prior therapy. Side effects like nausea, vomiting, and fatigue can affect how long a patient is able to continue taking Selinexor, which could mean that treatment might stop sooner.

Other names: Xpovio

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 2 years

    • VSAS: Veteran Symptom Assessment Scale (VSAS), a cancer symptom measurement tool.
  2. Primary Outcome Measure

    Time frame: 2 years

    • CTCAE: Common Terminology Criteria for Adverse Events, version 5.0, an adverse event measuring tool used in clinical trials.

Sponsors and collaborators

Lead sponsor

Durham VA Medical Center

Fed

Collaborators

  • Duke University

Registry information

Acronym: Selinexor

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 11, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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