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Anti-inflammatory Drug

Selinexor + Choline Salicylate for Lymphoma and Multiple Myeloma

Phase 1

Recruiting

Led By Jonas Paludo, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test for women of childbearing potential

Patients with relapsed and/or refractory multiple myeloma (RRMM) as per the International Myeloma Working Group (IMWG) uniform criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 cycles

Awards & highlights

Study Summary

This trial is testing the effects of choline salicylate and selinexor in treating patients with non-Hodgkin lymphoma or histiocytic/dendritic cell neoplasm.

Who is the study for?

Adults with certain types of blood cancers like non-Hodgkin or Hodgkin lymphoma, multiple myeloma, or histiocytic/dendritic cell neoplasm that haven't responded to previous treatments. Participants must be over 18, not pregnant, able to consent and follow-up, provide samples for research, have a specific level of disease severity and physical fitness (ECOG 0-2), and meet certain blood count criteria.Check my eligibility

What is being tested?

The trial is testing the combination of low-dose Selinexor with Choline Salicylate in patients whose cancer hasn't improved after prior treatment. It aims to find the safest dose while assessing how well these drugs work together against various types of lymphomas and multiple myeloma.See study design

What are the potential side effects?

Potential side effects may include immune system suppression due to Choline Salicylate's anti-inflammatory properties and growth inhibition-related effects from Selinexor blocking a protein necessary for cancer cells' survival.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant.

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My multiple myeloma has come back or didn't respond to treatment.

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I have been diagnosed with a specific type of lymphoma or histiocytic/dendritic cell cancer.

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I am 18 years old or older.

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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 cycles

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 cycles

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 cycles for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose of the combination of low-dose selinexor with choline salicylate

Secondary outcome measures

Clinical benefit rate

Duration of response

Incidence of adverse events

+1 more

Other outcome measures

CRM1 expression

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (selinexor, choline salicylate)Experimental Treatment2 Interventions

Patients receive selinexor PO BIW on days 1, 3, 8, 10, 15, 17, 22, and 24, and choline salicylate PO TID on days 1-28. Patients undergoing pharmacokinetic analysis receive choline salicylate beginning on D3C1 and beginning on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patents who achieve >= stable disease continue treatment for an additional 6 cycles (maximum of 12 cycles) at the discretion of the treating physician and patient.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selinexor

2020

Completed Phase 2

~1360

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Karyopharm TherapeuticsUNKNOWN

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,766,999 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,815 Total Patients Enrolled

Media Library

Choline Salicylate (Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04640779 — Phase 1

Hodgkin's Lymphoma Research Study Groups: Treatment (selinexor, choline salicylate)

Hodgkin's Lymphoma Clinical Trial 2023: Choline Salicylate Highlights & Side Effects. Trial Name: NCT04640779 — Phase 1

Choline Salicylate (Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04640779 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this medical research endeavor?

"The clinical trial data on clinicialtrials.gov attest to the fact that this experiment is actively recruiting participants, with initial posting occurring February 8th 2021 and a subsequent edit taking place April 4th 2022."

Answered by AI

What is the participant count for this medical study?

"Indeed, according to the clinicaltrials.gov directory, this investigation is currently open for enrolment. The inaugural posting of this trial was on February 8th 2021 and it has been recently updated as of April 4th 2022 with a goal of 39 participants at one site."

Answered by AI

Has the Food and Drug Administration greenlighted Choline Salicylate for consumer use?

"Assigning a score of 1, our team at Power has concluded that Choline Salicylate is safe enough to be tested on humans. This judgment was made based on the fact this trial is in Phase 1 and there are limited data points regarding its safety and effectiveness."

Answered by AI

What medical purpose is Choline Salicylate typically administered for?

"Delayed hypersensitivity is frequently treated with Choline Salicylate. This medication has also been known to offer relief from pain, catarrh, and epiphora."

Answered by AI

Does this medical experiment possess any groundbreaking characteristics?

"Ever since 2014, Choline Salicylate has been under intense clinical investigation. Initially sponsored by Karyopharm Therapeutics Inc., the first trial in 2014 had a sample size of 16 and successfully achieved Phase 1 drug approval afterwards. Currently, around 48 separate studies are being undertaken across 28 countries, with 259 cities involved."

Answered by AI

Have any previous experiments investigated Choline Salicylate?

"Presently, Bethesda is the epicenter for 48 active clinical trials exploring Choline Salicylate. Of those, 4 are in Phase 3. Furthermore, 922 medical centres across the globe are running these studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma

2021. "Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04640779.

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