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

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT07084896

This clinical trial is testing the safety and appropriate dosage of a new combination treatment using belantamab mafodotin and nirogacestat 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 nirogacestat is safe and well-tolerated in patients with relapsed or refractory multiple myeloma (RRMM). Researchers also aim to determine the best dose to use in future studies. This study is part of a larger research project.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of multiple myeloma.
  • 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 over 100 days ago, and you should not have any active infections.
  • Have a performance status score of 0 or 1, or 2 if due to bone issues from multiple myeloma.
  • 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.

Exclusion Criteria

  • Have current eye disease, except for mild conditions.
  • Have heart-related health risks.
  • Have allergies to drugs similar to belantamab mafodotin or its components.
  • Have active infections needing treatment.
  • Have used other monoclonal antibodies recently or had certain cancer treatments within the last few weeks.
  • Have had a recent allogeneic transplant or CAR-T therapy.
  • Have had major surgery recently, except for bone-stabilizing surgery.
  • Have had investigational treatments recently.
  • Have severe side effects from previous treatments that led to stopping those treatments.
  • Have had a blood transfusion recently.
  • Have received live vaccines recently or plan to during the study.
  • Have active kidney conditions affecting safety.
  • Have HIV unless specific conditions are met.
  • Have uncontrolled digestive or skin diseases.
  • Have conditions causing low levels of certain minerals that can't be corrected.
  • Have used a gamma secretase inhibitor before.
  • Are taking certain strong medications that affect how the body processes drugs.

Locations

FACILITYZIPCITYSTATE
23899530322AtlantaGeorgia
24059302215BostonMassachusetts
25116449546Grand RapidsMichigan
23901553792MadisonWisconsin

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