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A drug, linvoseltamab, compared to standard of care, to treat multiple myeloma that has come back (relapsed) or has not gotten better with treatment (refractory)

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Phase 3

10 Locations

NCT05730036

Clinical Trial Goal


To find out if linvoseltamab is safe and works well to treat multiple myeloma that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have multiple myeloma that has relapsed or is refractory 
  • Have been treated with lenalidomide 
  • Do not have any of the following:
    • Plasma cell leukemia
    • POEMS syndrome
    • Waldenstrom macroglobulinemia
  • Have not been treated with elotuzumab or pomalidomide. Your doctor can tell you this
  • Have not had an autologous (your own cells) blood or marrow transplant (BMT) in the last 3 months
  • Have not had an allogeneic (cells from a donor) BMT in the last 6 months
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Dexamethasone is a drug that reduces inflammation. 
Elotuzumab is a monoclonal antibody that targets SLAMF7 in some cancer cells.
Linvoseltamab is a bispecific antibody that targets BCMA and CD3 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 1 – Linvoseltamab
  • Group 2Dexamethasone, elotuzumab and pomalidomide

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 – Group 1 only - A pill that you take by mouth or given as intravenous (IV) infusions
  • Elotuzumab – Group 2 only - Given as IV infusions
  • Linvoseltamab - Group 1 only - Given as IV infusions The number of doses you'll get depends on when you start the trial and how safe it has been
  • Pomalidomide - Group 2 only - A pill that you take by mouth 

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 5 years.

The Food and Drug Administration (FDA) has dexamethasone, elotuzumab and pomalidomide for the treatment of multiple myeloma. The FDA has not yet approved linvoseltamab. 

Contacts


Clinical Trials Administrator, 844-734-6643, clinicaltrials@regeneron.com

Locations

UCLARECRUITING

Los Angeles, California

University of FloridaWITHDRAWN

Gainesville, Florida

Norton Cancer Institute - St. Matthews CampusRECRUITING

Louisville, Kentucky

University of KentuckyRECRUITING

Lexington, Kentucky

Stony Brook University HospitalRECRUITING

Stony Brook, New York

Duke University Medical CenterRECRUITING

Durham, North Carolina

Levine Cancer CenterRECRUITING

Charlotte, North Carolina

Kaiser Permanente NorthwestRECRUITING

Portland, Oregon

MD Anderson Cancer CenterRECRUITING

Houston, Texas

University of Washington-Seattle Cancer Care AllianceRECRUITING

Seattle, Washington

ClinicalTrials.gov record


NCT05730036. First posted on 2/15/23

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