Study of Selinexor with Carfilzomib, Isatuximab, and Dexamethasone for Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Natalie Callander

Sponsor score: 0

ClinicalTrials ID:NCT07479979

This clinical trial is testing a combination of four drugs—Selinexor, Carfilzomib, Isatuximab, and Dexamethasone—to see if they are safe and can help treat patients with multiple myeloma that has returned or is difficult to treat after previous therapies.

Patient Parameters

Program Overview

The main goal of this study is to find out if a combination of four drugs—Selinexor, Carfilzomib, Isatuximab, and Dexamethasone—is safe and can help treat patients with multiple myeloma that has come back or is hard to treat. The study will start with a small group of 6-12 patients to test safety, and if needed, the dose of Selinexor can be reduced. Then, up to 50 more patients will be treated with the best dose found to see how well it works.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a diagnosis of relapsed or hard-to-treat multiple myeloma and have received at least one previous treatment.
  • Have certain high-risk features in the cancer cells, such as specific genetic changes.
  • Have measurable disease, meaning the cancer can be measured by tests or scans.
  • Have good overall health with a performance status of 2 or less, unless bone pain is causing the higher score.
  • Have adequate organ function based on blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception and not donate sperm during the study.
  • Be willing to provide blood and bone marrow samples for research.
  • Patients with controlled HIV or hepatitis B/C infections may participate if the viral load is undetectable.
  • Must be able to understand and agree to the study procedures.

Exclusion Criteria

  • Have an active infection requiring treatment.
  • Be pregnant or breastfeeding.
  • Have another active cancer needing treatment, except for certain skin or cervical cancers.
  • Have cancer that has spread to the brain unless treated and stable.
  • Have had a severe allergic reaction to anti-CD38 antibodies.
  • Have uncontrolled health issues like heart failure or unstable heart conditions.
  • Have taken an investigational drug within 14 days before starting the study.
  • Have digestive issues that prevent taking oral medication.
  • Be taking certain medications that affect how the study drugs work and cannot stop them.
  • Have had previous treatment with Selinexor or similar drugs.
  • Have had anti-CD38 therapy within 6 months before the study.
  • Have a heart function test showing less than 40% function.
  • Have plasma cell leukemia or certain other blood disorders.

Locations

FACILITYZIPCITYSTATE
University of Wisconsin53705MadisonWisconsin

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.