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

NCT04640779 | Active Not Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: LS1981P50CA097274NCI-2020-0970419-009349
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This phase Ib trial evaluates the side effects and best dose of choline salicylate given together with a low dose of selinexor in treating patients with non-Hodgkin or Hodgkin lymphoma, or multiple myeloma whose prior treatment did not help their cancer (refractory) or for patients with histiocytic/dendritic cell neoplasm. Anti-inflammatory drugs, such as choline salicylate lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Selinexor may stop the growth of cancer cells by blocking a protein called CRM1 that is needed for cell growth. This trial may help doctors learn more about selinexor and choline salicylate as a treatment for with non-Hodgkin or Hodgkin lymphoma, histiocytic/dendritic cell neoplasm, multiple myeloma.

Conditions

Refractory Histiocytic and Dendritic Cell Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Recurrent Hodgkin Lymphoma; Recurrent Histiocytic and Dendritic Cell Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Refractory Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  Defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).

  Up to 12 cycles (a cycle is 28 days)

Secondary Outcomes (4)

• Incidence of adverse events

  Up to 12 cycles

• Overall response rate

  Up to 12 cycles (a cycle is 28 days)

• Clinical benefit rate

  Up to 12 cycles (a cycle is 28 days)

• Duration of response

  Up to 12 cycles (a cycle is 28 days)

Other Outcomes (1)

• CRM1 expression

  Up to 12 cycles (a cycle is 28 days)

Study Arms (1)

Treatment (selinexor, choline salicylate)

EXPERIMENTAL

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.

Drug: Choline Salicylate; Drug: Selinexor

Interventions

Choline Salicylate DRUG

Given PO

Treatment (selinexor, choline salicylate)

Selinexor DRUG

Given PO

Also known as: ATG-010, CRM1 Nuclear Export Inhibitor KPT-330, KPT-330, Selective Inhibitor of Nuclear Export KPT-330, SINE KPT-330, Xpovio

Treatment (selinexor, choline salicylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Non Hodgkin or Hodgkin lymphoma or histiocytic/dendritic cell neoplasm meeting one of the following criteria:
• Biopsy-proven relapsed and/or refractory Non-Hodgkin or Hodgkin lymphoma or histiocytic/dendritic cell neoplasms
• Relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted \> 26 weeks
• Refractory is no response (stable disease or progressive disease while on therapy) or relapse within 6 months. Refractoriness to autologous stem cell transplant will be defined as disease progression within 52 weeks following transplant OR
• Multiple myeloma neoplasm meeting the following criteria:
• Relapsed and/or refractory multiple myeloma (RRMM) as per the International Myeloma Working Group (IMWG) uniform criteria
• If extramedullary myeloma, most recent tumor biopsy must be \< 26 weeks prior to registration
• Measurable or assessable disease:
• For Non-Hodgkin or Hodgkin Lymphoma and histiocytic/dendritic cell:
• Measurable disease is defined as measurable by computed tomography (CT) \[dedicated CT or the CT portion of a positron emission tomography (PET)/CT\] or MRI: To be considered measurable, there must be at least one lesion that has a single diameter of \>= 1.5 cm NOTE: Skin lesions can be used if the area is \>= 1.5 cm in at least one diameter and photographed with a ruler. Patients with assessable disease by PET/CT are also eligible as long as the assessable disease is biopsy proven lymphoma or histiocytic/dendritic cell neoplasms
• For Multiple myeloma:
• Measurable disease by IMWG criteria as defined by at least one of the following:
• Serum M-protein \>= 0.5 g/dL
• Urine M-protein \>= 200 mg in a 24-hour collection

You may not qualify if:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant women
• Nursing women
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Patients known to have active hepatitis B, or C infection, or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg) \[hepatitis B virus (HBV) surface antigen\]. Patients known to be human immunodeficiency virus (HIV) positive, except those with CD4+ T-cell (CD4+) counts \>= 350 cells/microliter (µL) and on an established antiretroviral therapy (ART) for at least twelve weeks and have an HIV viral load less than 400 copies/mL prior to enrollment
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Life expectancy of \< 6 months
• Active gastrointestinal (GI) dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment
• Known intolerance to or contraindications for choline salicylate therapy. Patients with known allergy to acetylsalicylic acid (ASA) are not eligible
• Prior exposure to a selective inhibitors of nuclear export (SINE) compound, including selinexor
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer to this protocol therapy. Patients with treated malignancies on hormonal therapy (for example breast or prostate cancer) are eligible
• 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. NOTE: Exception: patients on any Bruton tyrosine kinase (BTK) inhibitor (ibrutinib, zanabrutinib, acalabrutinib, etc), or venetoclax, or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion. After the start of protocol therapy, corticosteroids can be used at investigator's discretion and tapered to lowest possible dose
• Active graft versus (vs.) host disease (after allogeneic stem cell transplantation) at registration

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

choline salicylate; selinexor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Jonas Paludo, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 23, 2020
• Study Start: February 8, 2021
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (1)