Study on Belantamab Mafodotin with Nirogacestat, Lenalidomide, and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT07150091

This clinical trial is testing a combination of drugs, including belantamab mafodotin, nirogacestat, lenalidomide, and dexamethasone, to see if they are safe and well-tolerated in patients with relapsed or refractory multiple myeloma (RRMM). The study aims to find the best dose for future research.

Patient Parameters

Program Overview

The main goal of this study is to determine if the combination of belantamab mafodotin with nirogacestat, lenalidomide, and dexamethasone is safe and can be tolerated by patients with relapsed or refractory multiple myeloma (RRMM). Researchers also want to establish the recommended dose for further studies. This study is part of a larger research protocol.

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 have had a stem cell transplant, it must have been over 100 days ago, and you should not have any active infections.
  • Must have a performance status score of 0 or 1, or 2 if due to bone issues from multiple myeloma.
  • Must have measurable disease based on specific medical tests.
  • If you have tested positive for Hepatitis B, certain conditions must be met to participate.
  • Can be on low-dose steroids or certain other medications.
  • Must have a platelet count of at least 75 x 10^9/L.

Exclusion Criteria

  • Have current eye disease, except mild conditions.
  • Have heart-related health risks.
  • Have allergies to the study drugs or similar medications.
  • Have active infections needing treatment.
  • Have used other monoclonal antibodies or anti-myeloma therapy recently.
  • Have had recent radiotherapy or major surgery.
  • Have had an allogeneic transplant or recent CAR-T therapy.
  • Have received investigational drugs recently.
  • Have severe side effects from previous treatments.
  • Have had recent blood transfusions.
  • Cannot receive live vaccines recently or during the study.
  • Have active kidney issues or need dialysis.
  • Have HIV unless specific conditions are met.
  • Have uncontrolled digestive or skin diseases.
  • Have electrolyte imbalances that can't be corrected.
  • Have used a gamma secretase inhibitor before.
  • Are taking certain medications that affect drug metabolism.
  • Have had recent blood clots or bleeding issues.
  • Cannot or will not take blood clot prevention medications.
  • Stopped lenalidomide due to severe side effects.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site02215BostonMassachusetts

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