Telehealth-based Symptom Management for Veterans Treated With Selinexor

NCT06452446 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: 1749975
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma; Large-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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.

Also known as: Xpovio

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Durham VA Medical Center: lead
• Duke University: collaborator

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Dendritic Cell Sarcoma, Interdigitating

Interventions

selinexor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis; Lymphatic Diseases

Study Officials

• Daphne Friedman, MD

  Durham VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (1)