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

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma; Large-cell Lymphoma
• 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

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	• VSAS: Veteran Symptom Assessment Scale (VSAS), a cancer symptom measurement tool.	2 years
Primary Outcome Measure	• CTCAE: Common Terminology Criteria for Adverse Events, version 5.0, an adverse event measuring tool used in clinical trials.	2 years

Collaborators and Investigators

• Sponsor: Durham VA Medical Center
• Collaborators: Duke University
• Investigators: Principal Investigator: Daphne Friedman, MD, Durham VA Medical Center

Study record dates

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: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma
• 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