Phase 3 Clinical Trial Comparing the Efficacy of an Investigational Medication Combined with Daratumumab or Daratumumab and Pomalidomide Versus Daratumumab, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. MONUMENTAL-3
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What's the purpose of this trial?

The goal of this clinical trial is to learn more about the efficacy of an investigational medication when combined with either Daratumumab and Pomalidomide or Daratumumab alone, and compare the efficacy to another regimen, Daratumumab, Pomalidomide and Dexamethasone. 

This trial is currently open and accepting patients.

What will happen during the trial?

This trial is organized into 28-day cycles. Participants in this trial will be randomly assigned in to one of three different groups, or arms. Participants in all arms may receive pre-treatment medications to help minimize the risk of side effects from the study drugs.

Treatment Involved

The investigational medication being studied is a type of drug called a bispecific antibody. Bispecific antibodies are drugs that have two different targets. This investigational medication’s two targets are CD3, a receptor found on our own T cells, and GPRC5D, a protein found on the surface of some myeloma cells. The investigational medication is being evaluated to determine if once in the body, it will draw the body’s T cells and myeloma cells closer together, resulting in T cell activation and myeloma cell death. 

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • have received at least one prior line of therapy, including a proteasome inhibitor and lenalidomide.
  • participants with only one line must be refractory to lenalidomide.
  • are not refractory to an anti-CD38 monoclonal antibody.
  • have not previously had treatment with any GPRC5D targeted therapy or Pomalidomide.
  • have not had an allogeneic stem cell transplant in the last six months, or an autologous stem cell transplant in the last three months.
  • do not have active autoimmune disease or history of autoimmune disease in the last two years. 

Additional Trial Information

Phase 3

Enrollment: 810 patients (estimated)

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Trial Links

Read the latest news and updates on this trial.

Multiple Myeloma in Clinical Trials

September 26, 2022

Click below to watch a short video about Multiple Myeloma clinical trial participation.

Read more

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

University of Arizona Cancer Center

Tucson, AZ

Open and Accepting

Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Open and Accepting

Connecticut

Whittingham Cancer Center at Norwalk Hospital Nuvance Health

Norwalk, CT

Open and Accepting

Florida

Memorial Cancer Institute Memorial Regional Hospital

Hollywood, FL

Open and Accepting

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Open and Accepting

Illinois

University of Illinois at Chicago

Chicago, IL

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Louisiana

Ochsner Medical Complex (The Grove)

Baton Rouge, LA

Open and Accepting

Tulane Cancer Center Tulane University School of Medicine

New Orleans, LA

Open and Accepting

Maryland

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Massachusetts

Boston Medical Center

Boston, MA

Open and Accepting

Massachusetts General Hospital

Boston, MA

Open and Accepting

University of Massachusetts Medical School

Worcester, MA

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting

Minnesota

University of Minnesota - Masonic Cancer Center

Minneapolis, MN

Open and Accepting

Mississippi

University of Mississippi Medical Center

Jackson, MS

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

SUNY Upstate Medical University State University of New York

Syracuse, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Open and Accepting

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Open and Accepting

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Open and Accepting

Ohio

University Hospitals Seidman Cancer Center Seidman Cancer Center at UH Case Medical

Cleveland, OH

Not Yet Accepting

OhioHealth Riverside Methodist Hospital

Columbus, OH

Open and Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, OK

Not Yet Accepting

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Open and Accepting

South Carolina

Medical University of South Carolina

Charleston, SC

Open and Accepting

Tennessee

Baptist Cancer Center Memphis

Mempis, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Houston Methodist Hospital

Houston, TX

Open and Accepting

Joe Arrington Cancer Research and Treatment Center Covenant Health

Lubbock, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Massey Cancer Center Virginia Commonwealth University (VCU Health)

Richmond, VA

Open and Accepting

Washington

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Open and Accepting

Washington, D.C.

George Washington University Hospital

Washington, DC

Open and Accepting

Georgetown Lombardi Comprehensive Cancer Center MedStar Georgetown University Hospital

Washington, DC

Open and Accepting
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