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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
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 belowSelect...
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:Select...
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
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 moreOther study objectives
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 3
~1730
Find a Location
Who is running the clinical trial?
Karyopharm TherapeuticsUNKNOWN
Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,406 Total Patients Enrolled
77 Trials studying Multiple Myeloma
10,050 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,961 Total Patients Enrolled
590 Trials studying Multiple Myeloma
189,318 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a disease that can be measured or assessed according to specific guidelines.I haven't had cancer treatment like radiation or chemotherapy in the last 2 weeks.I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.You have other serious health problems in addition to the one being studied.I have stomach or intestine problems that make it hard for me to swallow pills.I am not pregnant.I cannot tolerate or am not allowed to take choline salicylate.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am not currently taking blood thinners like DOACs, aspirin, or warfarin.I have previously been treated with a SINE compound like selinexor.I have another cancer that needs treatment which might affect this study's results.You have HIV, unless your CD4+ T-cell count and viral load are within specific levels.I am currently experiencing graft-versus-host disease after a stem cell transplant.My multiple myeloma has come back or didn't respond to treatment.I am not eligible for or have declined stem cell or CAR-T cell therapy.I have been diagnosed with a specific type of lymphoma or histiocytic/dendritic cell cancer.I do not have active hepatitis B or C.Your blood test results need to be within certain ranges.I have not had major surgery in the last 3 weeks.You are expected to live for less than 6 months.I am 18 years old or older.I have an active lymphoma in my brain or spinal cord.I am able to care for myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selinexor, choline salicylate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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