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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.

Choline Salicylate

Selinexor

Clinical Trials Referral Office

Jonas Paludo, M.D.

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.

PRIMARY OBJECTIVE:

I. To evaluate the maximum tolerated dose (MTD) of choline salicylate (CS) that can be combined with selinexor twice weekly in patients with relapsed/refractory non-Hodgkin, Hodgkin lymphoma, histiocytic/dendritic cell neoplasms, or relapsed/refractory (RR) multiple myeloma (MM).

SECONDARY OBJECTIVE:

I. To evaluate the response (overall response rate \[ORR\], clinical benefit rate \[CBR\] and duration of response \[DOR\]) of selinexor and CS in patients with relapsed/refractory non-Hodgkin or Hodgkin lymphoma, histiocytic/dendritic cell neoplasms, or multiple myeloma.

CORRELATIVE RESEARCH OBJECTIVE:

I. To determine if CRM1, RAD51, gH2AX, BRCA1 and 53BP1 expressions in malignant lymphoma cells, extramedullary myeloma, or histiocytic/dendritic cell neoplasm cells from those patients treated on this study have a predictive role.

OUTLINE: This is a dose-escalation study.

Patients receive selinexor orally (PO) twice a week (BIW) on days 1, 3, 8, 10, 15, 17, 22, and 24, and choline salicylate PO three times daily (TID) on days 1-28. Patients undergoing pharmacokinetic analysis receive choline salicylate beginning on day 3 of cycle 1 (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.

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

Phase Ib Trial of Low-Dose Selinexor (KPT-330) in Combination With Choline Salicylate (CS) for the Treatment of Patients With Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasms, or Multiple Myeloma

Will determine if the CRM1 expression grade, via immunohistochemistry and reported as grade 1 (low), grade 2 (moderate) and grade 3 (high), in malignant cells correlates with overall response rate after treatment with selinexor.

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).

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns (overall and by dose level). Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

Response will be evaluated using all cycles of treatment. Exact binomial 95% confidence intervals for the true response rate will be calculated.

The distribution of duration of response will be estimated using the method of Kaplan-Meier.

National Cancer Institute (NCI)

Mayo Clinic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma	NCT04640779	Recurrent Histi... Recurrent Hodgk... Recurrent Non-H... Recurrent Plasm... Refractory Hist... Refractory Hodg... Refractory Non-... Refractory Plas...	Choline Salicyl... Selinexor	18 Years -	Mayo Clinic
Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma	NCT04640779	Recurrent Histi... Recurrent Hodgk... Recurrent Non-H... Recurrent Plasm... Refractory Hist... Refractory Hodg... Refractory Non-... Refractory Plas...	Choline Salicyl... Selinexor	18 Years -	Mayo Clinic

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