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Active Not RecruitingNCT06452446

Telehealth-based Symptom Management for Veterans Treated With Selinexor

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Durham VA Medical Center · Federal
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGSelinexorSelinexor 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.

Timeline

Start date
2024-09-01
Primary completion
2026-07-01
Completion
2028-07-01
First posted
2024-06-11
Last updated
2025-02-10

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06452446. Inclusion in this directory is not an endorsement.