Study Comparing Two Treatment Combinations for Relapsed or Refractory Multiple Myeloma

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT04246047

Provider View

This clinical trial is testing the safety and effectiveness of two different treatment combinations for patients with multiple myeloma that has returned or not responded to previous treatments. One group will receive belantamab mafodotin with bortezomib and dexamethasone, while the other group will receive daratumumab with bortezomib and dexamethasone.

Patient Parameters

Program Overview

This Phase 3 study aims to compare the safety and effectiveness of two treatment combinations for patients with multiple myeloma that has come back or not responded to previous treatments. Participants will be randomly assigned to one of two groups: one group will receive belantamab mafodotin with bortezomib and dexamethasone, and the other group will receive daratumumab with bortezomib and dexamethasone. The study will help determine which combination works better for treating relapsed or refractory multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of multiple myeloma.
  • Have been treated with at least one previous therapy for multiple myeloma and have experienced disease progression during or after the last treatment.
  • Have a performance status score between 0 and 2, indicating full activity or some restriction in strenuous activities.
  • Have at least one measurable sign of the disease, such as:
    • Urine protein levels of 200 mg or more per 24 hours.
    • Blood protein levels of 0.5 grams per deciliter or more.
    • Abnormal levels of free light chains in the blood.
  • Have no severe side effects from previous treatments, except for hair loss.
  • Have adequate organ function.

Exclusion Criteria

  • Cannot tolerate daratumumab.
  • Have not responded to daratumumab or other similar treatments.
  • Cannot tolerate bortezomib or have not responded to it when given at a specific dose.
  • Have ongoing moderate to severe nerve pain or damage.
  • Have previously received anti-BCMA therapy.
  • Have had a stem cell transplant from a donor.
  • Have serious or unstable medical or psychiatric conditions, including issues with the kidneys, liver, heart, or certain past cancers.
  • Have corneal epithelial disease.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site85364YumaArizona
GSK Investigational Site80218DenverColorado
GSK Investigational Site66205Kansas CityKansas
GSK Investigational Site45242FairfieldOhio
GSK Investigational Site75702TylerTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.