Study on Different Dosing Schedules of Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05064358

Provider View

This clinical trial is exploring different dosing schedules of the drug belantamab mafodotin to see if changing the dose or timing can improve treatment outcomes for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test different ways of giving the drug belantamab mafodotin to patients with relapsed or refractory multiple myeloma. Researchers want to find out if adjusting the dose or schedule of this medication can provide better results and fewer side effects for patients whose cancer has come back or hasn't responded to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of multiple myeloma and have either had a stem cell transplant or are not eligible for one.
  • Have tried at least three different treatments for multiple myeloma, including a CD38 antibody and are resistant to certain other drugs.
  • In France, must have tried at least four different treatments.
  • Have measurable disease according to specific criteria.
  • Have a life expectancy of at least 6 months.
  • Agree to use contraception as defined in the study.
  • Be able to give informed consent.
  • Meet any additional country-specific criteria.

Exclusion Criteria

  • Have certain other conditions like amyloidosis, active POEMS syndrome, or active plasma cell leukemia.
  • Have current eye problems, except for mild cases.
  • Have active bleeding issues.
  • Have an active kidney condition.
  • Have any serious or unstable medical or psychiatric conditions.
  • Have had another cancer, unless it has been in remission for over 2 years or is a non-threatening type like certain skin cancers.
  • Have certain heart risks.
  • Be pregnant or breastfeeding.
  • Have an active infection needing treatment.
  • Have HIV, unless specific criteria are met.
  • Have hepatitis B or C, unless specific criteria are met.
  • Have liver disease or cirrhosis.
  • Have high liver enzyme levels.
  • Have received certain treatments recently, like systemic anti-myeloma therapy or high-dose steroids.
  • Have had a stem cell transplant from a donor.
  • Have had certain antibody treatments recently.
  • Have had treatment targeting BCMA or have allergies to study drugs.
  • Have had major surgery recently, except for bone-stabilizing surgery.
  • Have low blood cell counts or poor organ function as specified in the study.
  • In the UK, have specific lower blood cell count thresholds.

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