RecruitingPhase 1NCT06225310

A Trial of Selinexor, Ruxolitinib and Methylprednisolone

A Phase I Trial of Selinexor, Ruxolitinib and Methylprednisolone for Patients With Relapsed/Refractory Multiple Myeloma

Sponsor

Oncotherapeutics

Enrollment

30 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma in Relapse Multiple Myeloma, Refractory

Summary

Selinexor, a first-in-class, oral selective exportin 1 (XPO1) inhibitor, has shown promise in pre-clinical and clinical studies. It functions by inhibiting the nuclear export protein XPO1, resulting in the accumulation of tumor suppressor proteins and inhibition of oncoprotein mRNAs, which is selectively lethal to myeloma cells. Selinexor has demonstrated activity in combination with various drugs, including glucocorticoids and proteasome inhibitors, leading to its FDA approval for the treatment of relapsed or refractory multiple myeloma.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — selinexor, ruxolitinib, and methylprednisolone — in people with heavily pre-treated relapsed or refractory multiple myeloma (a type of blood cancer) who have already tried at least three prior treatment regimens. **You may be eligible if...** - You have been diagnosed with multiple myeloma - Your myeloma has relapsed or stopped responding to at least three prior treatments - Your prior treatment included an anti-CD38 antibody, an immunomodulatory drug, and a proteasome inhibitor - Your myeloma is currently measurable (detectable on blood, urine, or imaging tests) - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have active brain involvement from myeloma - You have serious uncontrolled infections or heart problems - You are pregnant or breastfeeding - You have had a recent serious cardiovascular event (heart attack, etc.) - Your liver or kidney function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor

Selinexor (KPT-330) is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in t

DRUGRuxolitinib

elective inhibitor of Janus kinase (JAK)

DRUGMethylprednisolone

Glucocorticoid, steroid