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

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18 and older

Phase 3

36 Locations

NCT05552976

Clinical Trial Goal


To find out if mezigdomide is safe and works well to treat multiple myeloma that has relapsed or is refractory compared to standard care

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 the following:
    • An anti-CD38 monoclonal antibody like daratumumab
    • Lenalidomide 
  • Have not been treated with carfilzomib or mezigdomide. 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
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Carfilzomib is a small molecule inhibitor that blocks proteasome function in certain cells.
Dexamethasone is a drug that reduces inflammation. 
Mezigdomide is an immunomodulatory drug that doctors think will help fight 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 1Carfilzomib and dexamethasone
  • Group 2Carfilzomib and dexamethasone plus mezigdomide

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: 
  • Carfilzomib – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Dexamethasone - Given as a pill you take by mouth
  • Mezigdomide Group 2 only - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been


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 approved carfilzomib and dexamethasone for the treatment of multiple myeloma. The FDA has not yet approved mezigdomide.

Contacts


BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

Locations

Local Institution - 0046ACTIVE_NOT_RECRUITING

Mobile, Alabama

Local Institution - 0005ACTIVE_NOT_RECRUITING

Cerritos, California

Local Institution - 0187ACTIVE_NOT_RECRUITING

Los Angeles, California

Local Institution - 0190ACTIVE_NOT_RECRUITING

Irvine, California

Local Institution - 0339COMPLETED

Stockton, California

Local Institution - 0344COMPLETED

Santa Rosa, California

Local Institution - 0279NOT_YET_RECRUITING

Newark, Delaware
Site 0279

Local Institution - 0341ACTIVE_NOT_RECRUITING

Fort Myers, Florida

Local Institution - 0340COMPLETED

West Palm Beach, Florida

Local Institution - 0342COMPLETED

St. Petersburg, Florida

Local Institution - 0291ACTIVE_NOT_RECRUITING

Atlanta, Georgia

Local Institution - 0348ACTIVE_NOT_RECRUITING

Atlanta, Georgia

Saint Alphonsus Regional Medical CenterNOT_YET_RECRUITING

Boise, Idaho
Bobby Chawla, Site 0203, 208-367-3131

Local Institution - 0289COMPLETED

Annapolis, Maryland

Local Institution - 0204ACTIVE_NOT_RECRUITING

Boston, Massachusetts

Local Institution - 0346ACTIVE_NOT_RECRUITING

Minneapolis, Minnesota

Local Institution - 0222ACTIVE_NOT_RECRUITING

Little Silver, New Jersey

Local Institution - 0199ACTIVE_NOT_RECRUITING

The Bronx, New York

University of North Carolina Medical CenterWITHDRAWN

Chapel Hill, North Carolina

Local Institution - 0172ACTIVE_NOT_RECRUITING

Columbus, Ohio

Local Institution - 0322ACTIVE_NOT_RECRUITING

Cleveland, Ohio

Local Institution - 0321ACTIVE_NOT_RECRUITING

Providence, Rhode Island

Local Institution - 0338ACTIVE_NOT_RECRUITING

Greer, South Carolina

Charleston Oncology, P.A.WITHDRAWN

Charleston, South Carolina

Local Institution - 0323ACTIVE_NOT_RECRUITING

Nashville, Tennessee

Local Institution - 0349ACTIVE_NOT_RECRUITING

Chattanooga, Tennessee

Local Institution - 0044ACTIVE_NOT_RECRUITING

Houston, Texas

Local Institution - 0328ACTIVE_NOT_RECRUITING

Houston, Texas

Local Institution - 0337ACTIVE_NOT_RECRUITING

Fort Worth, Texas

Local Institution - 0195COMPLETED

Temple, Texas

Local Institution - 0343ACTIVE_NOT_RECRUITING

Roanoke, Virginia

Local Institution - 0345ACTIVE_NOT_RECRUITING

Norfolk, Virginia

Local Institution - 0006ACTIVE_NOT_RECRUITING

Tacoma, Washington

Local Institution - 0347COMPLETED

Vancouver, Washington

Local Institution - 0243COMPLETED

Morgantown, West Virginia

Local Institution - 0336ACTIVE_NOT_RECRUITING

Marshfield, Wisconsin

ClinicalTrials.gov record


NCT05552976. First posted on 9/23/22

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