NCT04640779

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Choline Salicylate	Given PO
DRUG	Selinexor	Given PO

Timeline

• Start date: 2021-02-08
• Primary completion: 2026-06-18
• Completion: 2026-06-18
• First posted: 2020-11-23
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study