Multiple MyelomaSelinexorNCT06452446
Telehealth-based Symptom Management for Veterans Treated With Selinexor
An observational study of Multiple Myeloma and Large-cell Lymphoma, run by Durham VA Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Multiple Myeloma, Large-cell Lymphoma
- What is being tested?
- Selinexor
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center
Durham, North Carolina, 27705
About this study
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.
- Conditions
- Multiple Myeloma, Large-cell Lymphoma
- Being tested
- Selinexor
- Medical subject headings
- Multiple Myeloma, Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called Xpovio
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
- VSAS: Veteran Symptom Assessment Scale (VSAS), a cancer symptom measurement tool.
Measured: 2 years
Primary Outcome Measure
- CTCAE: Common Terminology Criteria for Adverse Events, version 5.0, an adverse event measuring tool used in clinical trials.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Durham VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Daphne Friedman, MD, Principal investigator, Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452446
- Sponsor's protocol ID
- 1749975
- Acronym
- Selinexor
- Status last verified
- Feb 2025
- First submitted
- 5 Jun 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-based Symptom Management for Veterans Treated With Selinexor
- ClinicalTrials.gov ID
- NCT06452446
- Acronym / sponsor ID
- Selinexor / 1749975
- Conditions
- Multiple Myeloma, Large-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Durham VA Medical CenterUS federal agency
- Collaborators
- Duke University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorAlso: XpovioSelinexor 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. | Drug | – |
Primary outcome
Primary Outcome Measure
Time frame: 2 years
• VSAS: Veteran Symptom Assessment Scale (VSAS), a cancer symptom measurement tool.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne Friedman, MD principal investigator
Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Large-cell Lymphoma, run by Durham VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.