Study on Belantamab Mafodotin and Feladilimab for Treating Relapsed or Refractory Multiple Myeloma

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT07217119

This clinical trial is testing the safety and best dose of a new combination treatment using belantamab mafodotin and feladilimab for patients with relapsed or refractory multiple myeloma (RRMM).

Patient Parameters

Program Overview

The main goal of this study is to find out if the combination of belantamab mafodotin and feladilimab is safe and well-tolerated in patients with relapsed or refractory multiple myeloma (RRMM). Researchers also aim to determine the best dose for future studies. This study is part of a larger research program.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of multiple myeloma.
  • Must have received at least three previous treatments for multiple myeloma, including specific types of drugs.
  • If you had a stem cell transplant, it must have been more than 100 days ago, and you should not have any active infections.
  • Must be in good general health, with a performance status score of 0 or 1, unless bone issues from multiple myeloma are the only reason for a score of 2.
  • Must have measurable disease, which means certain levels of proteins in the blood or urine.
  • If you have tested positive for Hepatitis B, you can still participate if certain conditions are met.
  • Can be taking low doses of steroids or using inhaled or eye-drop steroids.

Exclusion Criteria

  • Have current eye problems, except for mild issues.
  • Have heart-related health risks.
  • Have allergies to the study drugs or similar medications.
  • Have an active infection needing treatment.
  • Have used other monoclonal antibodies or anti-myeloma treatments recently.
  • Have had radiation therapy recently.
  • Have had a donor stem cell transplant.
  • Have had CAR-T cell therapy with chemotherapy recently.
  • Have had major surgery recently.
  • Have used experimental treatments recently.
  • Have severe side effects from previous treatments.
  • Have had a blood transfusion recently.
  • Should not receive live vaccines recently or during the study.
  • Have active kidney problems, except for protein in urine from multiple myeloma.
  • Have HIV, unless certain conditions are met.
  • Have autoimmune diseases needing treatment in the past two years.
  • Have had heart inflammation recently.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site30322AtlantaGeorgia
GSK Investigational Site53792MadisonWisconsin

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