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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

Must not have

History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 cycles

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.

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I haven't had cancer treatment like radiation or chemotherapy in the last 2 weeks.

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I have stomach or intestine problems that make it hard for me to swallow pills.

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I cannot tolerate or am not allowed to take choline salicylate.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not currently taking blood thinners like DOACs, aspirin, or warfarin.

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I have previously been treated with a SINE compound like selinexor.

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I have another cancer that needs treatment which might affect this study's results.

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I am currently experiencing graft-versus-host disease after a stem cell transplant.

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I am not eligible for or have declined stem cell or CAR-T cell therapy.

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I do not have active hepatitis B or C.

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I have an active lymphoma in my brain or spinal cord.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Clinical benefit rate

Duration of response

Incidence of adverse events

+1 more

Other study objectives

CRM1 expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~1730

0 / 17Eligibility criteria met