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Two drugs, dexamethasone and pomalidomide, in combination with belantamab mafodotin or bortezomib, to treat multiple myeloma that has come back (relapsed) or has not gotten better with treatment (refractory)

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Phase 3

5 Locations

NCT04484623

Clinical Trial Goal


To find out if the combination of belantamab mafodotin, dexamethasone and pomalidomide is safe and works better to treat multiple myeloma that has relapsed or is refractory compared to bortezomib, dexamethasone and pomalidomide

You may be able to join this trial if you:


  • Are 18 years or older 
  • Have multiple myeloma that has relapsed or is refractory
  • Have been treated with lenalidomide. Your doctor can tell you this 
  • Have not been treated with pomalidomide. Your doctor can tell you this
  • Have not been treated with belantamab or another beta cell maturation antigen (BCMA) targeted therapy. Your doctor can tell you this
  • Do not have multiple myeloma that is refractory to treatment with bortezomib. Your doctor can tell you this
  • Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Belantamab mafodotin is an antibody-drug conjugate, or combination, that targets BCMA on certain cells. 
Bortezomib is a small molecule inhibitor that blocks proteasome function in certain cells. Pomalidomide is a drug that blocks the growth of cancer cells.  

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in: 
  • Group 1dexamethasone and pomalidomide plus belantamab mafodotin
  • Group 2 dexamethasone and pomalidomide plus bortezomib  

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.  

You’ll get:
  • Dexamethasone – A pill that you take by mouth 
  • Pomalidomide – A pill that you take by mouth 
  • Belantamab mafodotin (Group 1 only) – Given as intravenous (IV) infusions
  • Bortezomib – (Group 2 only) – Given as IV infusions. These infusions are shorter than typical infusions.  

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 7 years.    

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial to treat multiple myeloma. Using them together in this way to treat multiple myeloma that has relapsed or is refractory is new and unproven.

Contacts


US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center, +44 (0) 20 89904466, GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational SiteACTIVE_NOT_RECRUITING

Tucson, Arizona

GSK Investigational SiteACTIVE_NOT_RECRUITING

Fort Myers, Florida

GSK Investigational SiteACTIVE_NOT_RECRUITING

Boston, Massachusetts

GSK Investigational SiteACTIVE_NOT_RECRUITING

Kansas City, Missouri

GSK Investigational SiteACTIVE_NOT_RECRUITING

Nashville, Tennessee

ClinicalTrials.gov record


NCT04484623. First posted on 7/23/20

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