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| Name | Class |
|---|---|
| Duke University | OTHER |
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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Daphne Friedman, MD | Durham VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C585161 | selinexor |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |