RecruitingPhase 2NCT04661137

A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma

A Phase 2B Study of Selinexor (KPT-330), in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma Relapsing on Current Therapy


Sponsor

Hackensack Meridian Health

Enrollment

96 participants

Start Date

Mar 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, 2-arm (with an additional exploratory arm), open-label, multicenter study looking at the response rate of patients receiving selinexor (KPT-330), in combination with carfilzomib, daratumumab or pomalidomide. Multiple Myeloma patients with documented disease progression or refractory disease while on current treatment with any carfilzomib-containing regimen (arm 1), any pomalidomide-containing regimen (arm 2) or any daratumumab-containing regimen (exploratory arm) will be included in the study. Patients will be assigned to the respective groups according to their current treatment. If a subject has received more than one of the above therapies, then assignment will be made at their physician's discretion (e.g treatment decision can be made based upon patient and physician preferred tolerance.). Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard of care, or withdrawal, whichever occurs first.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Carfilzomib, a drug called Daratumumab, and others for people with multiple myeloma. The study is currently recruiting participants at 2 locations.

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 60 MG

Selinexor 60 mg PO on days 1, 8 and 15

DRUGSelinexor 80 MG

Selinexor 80 mg PO on days 1, 8 and 15

DRUGSelinexor 100 MG

Selinexor 100 mg PO on days 1, 8, 15 and 22

DRUGCarfilzomib

56 mg/m2 IV on days 1, 8 and 15

DRUGPomalidomide

4 mg PO daily for 21 days

DRUGDaratumumab

16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on

DRUGDexamethasone

20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22


Locations(2)

Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT04661137


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