Study Comparing Belantamab Mafodotin with Pomalidomide and Dexamethasone Versus Bortezomib with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04484623

This clinical trial is testing two different treatment combinations to see which is more effective and safe 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 compare the effectiveness and safety of two treatment combinations for patients with relapsed or refractory multiple myeloma. One group will receive belantamab mafodotin with pomalidomide and dexamethasone, while the other group will receive bortezomib with pomalidomide and dexamethasone. The study aims to determine which combination works better in controlling the disease.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent.
  • Male or female, 18 years or older.
  • Diagnosed with multiple myeloma according to specific medical criteria.
  • In good general health with a performance status score of 0 to 2.
  • Previously treated with at least one line of therapy for multiple myeloma, including a regimen with lenalidomide, and have shown disease progression during or after the last treatment.
  • Have at least one measurable sign of the disease, such as specific levels of proteins in the blood or urine.
  • Have had a stem cell transplant or are not eligible for one. If previously transplanted, it must have been over 100 days ago and without active infections.
  • Any previous treatment side effects must be mild or resolved, except for hair loss.
  • Have adequate organ function as specified in the study protocol.
  • Agree to use effective birth control methods as required by the study.

Exclusion Criteria

  • Have active plasma cell leukemia, amyloidosis, or certain other conditions at screening.
  • Have had an allogeneic stem cell transplant.
  • Have received anti-myeloma treatment or certain medications recently before starting the study.
  • Have had plasmapheresis within 7 days before starting the study.
  • Have been treated with or cannot tolerate pomalidomide.
  • Have received treatment targeting BCMA.
  • Cannot tolerate or did not respond to bortezomib.
  • Have certain heart conditions or recent heart events.
  • Have had major surgery in the last 4 weeks.
  • Have another invasive cancer, unless stable for at least 2 years or only receiving hormonal therapy.
  • Have allergies to study drugs or their components.
  • Have active bleeding or certain liver diseases.
  • Have active infections requiring treatment.
  • Have HIV, hepatitis B, or hepatitis C unless meeting specific criteria.
  • Have severe kidney conditions or other conditions affecting safety.
  • Have significant nerve pain or damage.
  • Have had blood clots in the last 3 months.
  • Cannot or will not take required blood clot prevention.
  • Have certain eye diseases.
  • Have serious or unstable medical or psychiatric conditions.
  • Are pregnant or breastfeeding.

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