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A Trial of Selinexor, Ruxolitinib and Methylprednisolone

NCT06225310 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-16

No results posted yet for this study

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.

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma, Refractory

Interventions

DRUG

Selinexor

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

DRUG

Ruxolitinib

elective inhibitor of Janus kinase (JAK)

DRUG

Methylprednisolone

Glucocorticoid, steroid

Sponsors & Collaborators

  • Oncotherapeutics

    lead INDUSTRY

Principal Investigators

  • James Berenson, MD · Oncotherapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2027-04-01
Completion
2027-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06225310 on ClinicalTrials.gov