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Active, not recruitingNCT06452446SelinexorUpdated Feb 10, 2025

Telehealth-based Symptom Management for Veterans Treated With Selinexor

An observational study in Multiple Myeloma and Large-cell Lymphoma, sponsored by Durham VA Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Durham VA Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Multiple Myeloma
  • Large-cell Lymphoma

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03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 20 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Durham VA Medical Center is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Enrolled subjects will be Veterans with either relapsed/refractory multiple myeloma or diffuse large B-cell lymphoma who will be initiating Selinexor or Selinexor-based therapy, as recommended by treating oncologist.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • DrugSelinexor

    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.

    Also known as: Xpovio

06

What researchers measure

Primary outcomes

  1. Primary Outcome Measure

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

    Time frame: 2 years

  2. Primary Outcome Measure

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

    Time frame: 2 years

07

Study locations

1 site
  • Durham VA Medical Center
    Durham, North Carolina 27705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06452446
Lead sponsor
Durham VA Medical Center
Collaborators
Duke University
Responsible party
Sponsor
First posted
Jun 11, 2024
Start date
Sep 1, 2024
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Feb 10, 2025

Study contacts

Daphne Friedman, MD
principal investigator · Durham VA Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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