Phase 3 Clinical Trial Comparing the Safety and Efficacy of Belantamab Mafodotin, Lenalidomide and Dexamethasone Versus Daratumumab, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma who are Ineligible for Autologous Stem Cell Transplant DREAMM-10
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What's the purpose of this trial?

The goal of this clinical trial is to compare the safety and efficacy of belantamab mafodotin combinated with lenalidomide and dexamethasone to the combination of daratumumab, lenalidomide and dexamethasone in participants who have newly diagnosed multiple myeloma and are not eligible for autologous stem cell transplantation.

This trial is currently open and accepting patients.

What will happen during the trial?

In DREAMM-10, the study drug (belantamab mafodotin) will be combined with 2 drugs already approved to treat multiple myeloma, lenalidomide and dexamethasone. Everyone in the study will take these 2 standard drugs, but some will also take, daratumumab, instead of belantamab mafodotin. Daratumumab, also approved for multiple myeloma, will serve as the ‘control’, which means the study drug (belantamab mafodotin) will be compared to it.

After screening to check if DREAMM-10 is a good fit, participants will be randomly assigned (as if by the flip of a coin, or a 50/50 chance) To 1 of the 2 treatment “arms” (groups).

Depending on your treatment arm, you will get intravenous (IV, through a vein in your arm) treatment or subcutaneous injection (needle beneath the skin). Both groups will also take capsules and tablets by mouth.

You may continue to receive treatment unless your multiple myeloma gets worse or you have unwanted side effects or choose to discontinue participation.

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 newly diagnosed multiple myeloma and are ineligible for autologous stem cell transplantation.
  • have measurable disease as defined by the trial criteria.
  • have not had prior systemic treatment for multiple myeloma or smoldering multiple myeloma.
  • do not have central nervous system involvement of your multiple myeloma.
  • have adequate organ function as described by the trial criteria.

Additional Trial Information

Phase 3

Enrollment: 520 patients (estimated)

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Trial Locations

All Trial Locations

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Alabama

Infirmary Cancer Care

Mobile, AL

Open and Accepting

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

Beverly Hills Cancer Center

Beverly Hills, CA

Open and Accepting

Colorado

Rocky Mountain Cancer Centers

Aurora, CO

Open and Accepting

Florida

Florida Cancer Specialists - East

Brooksville, FL

Not Yet Accepting

Florida Cancer Specialists - North - The Villages

Lady Lake, FL

Open and Accepting

Millennium Oncology Research Clinic

Pembroke Pines, FL

Open and Accepting

Florida Cancer Specialists - South

South Pasadena, FL

Not Yet Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Maine

MaineHealth Cancer Care - South Portland

South Portland, ME

Open and Accepting

Massachusetts

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

Montana

St. Vincent Frontier Cancer Center

Billings, MT

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Not Yet Accepting

New York

Weill Cornell

New York, NY

Not Yet Accepting

Stony Brook University Hospital

Stony Brook, NY

Open and Accepting

North Carolina

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Open and Accepting

Ohio

OhioHealth Riverside Methodist Hospital

Columbus, OH

Open and Accepting

Rhode Island

Lifespan Rhode Island Hospital

Providence, RI

Open and Accepting

Texas

Texas Oncology - Austin Midtown

Austin, TX

Open and Accepting

University of Texas at Austin

Austin, TX

Not Yet Accepting

Lumi Research

Kingwood, TX

Open and Accepting

Texas Oncology - San Antonio Medical Center

San Antonio, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting

Virginia

Virginia Cancer Specialists

Fairfax, VA

Open and Accepting

Washington

Northwest Medical Specialties (Puyallup)

Puyallup, WA

Not Yet Accepting

Northwest Medical Specialties (Tacoma) NWMS Tacoma — Medical Oncology & Infectious Diseases

Tacoma, WA

Not Yet Accepting

Washington, D.C.

Georgetown Lombardi Comprehensive Cancer Center MedStar Georgetown University Hospital

Washington, DC

Not Yet Accepting
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