Selinexor in Multiple Myeloma and Large-cell Lymphoma - Clinical Trials Registry

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Drug: Selinexor

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Durham, North Carolina, United States, 27705
    - Durham VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durham VA Medical Center

Collaborators

Duke University

Investigators

Principal Investigator: Daphne Friedman, MD, Durham VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

1749975

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Telehealth-based Symptom Management for Veterans Treated With Selinexor (Selinexor)