A Phase 3, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Low Dose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3) Verified

What's the purpose of this trial?

The goal of this Phase 3 clinical trial is to test how safe and effective Belantamab Mafodotin is in the treatment of relapsed/refractory myeloma. One group of patients will receive Belantamab Mafodotin, and the other will receive Pomalidomide + low dose Dexamethasone. Researchers will compare the two groups of patients to help them understand how well Belantamab Mafodotin works when compared to Pomalidomide + Dexamethasone.

This trial is currently open and accepting patients.


What's being studied?

  • Belantamab Mafodotin (GSK2857916) is an investigational product that acts as an antibody-drug conjugate (ADC) with anti-BCMA antibody that binds to BCMA on tumor cell surfaces.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments that also has anti-cancer activity.
  • Pomalidomide is an immunomodulatory drug that can help your body fight cancer by slowing tumor growth.

What will happen during the trial?

This trial is seeking approximately 320 patients, and organized into two separate groups, called arms. This trial is randomized, which means patient will be randomly assigned into their group. This trial is open label, which means that both the patients and doctors will know which group they have been assigned to, and which drugs they will be receiving.

ARM 1

  • This arm will receive Belantamab Mafodotin over a 21 day cycle. Patient will receive Belantamab Mafodotin by intravenous infusion on day 1. Patients will need to visit the clinic every three weeks for testing and to receive their dose of Belantamab Mafodotin.
  • Patients in Arm 1 will undergo eye evaluations every three weeks for the first three cycles of the study. From cycle 4 onwards, if there are no ocular side effects, eye exams will then be given every 12 weeks.
  • Patients in Arm 1 will not be permitted to use contact lenses while they are receiving Belantamab Mafodotin. Patients will be required to use lubricating eye drops 4-8 times daily, and use a cooling eye mask while receiving their infusion The study eye doctor will tell you when you can start using contact lenses again after stopping Belanatamb Mafodotin, usually this is 45 days after your last dose.

ARM 2

  • This arm will receive Pomalidomide and Dexamethasone over a 28 day cycle.
    • Pomalidomide will be taken orally on days 1-21
    • Dexamethasone will be taken orally on days 1, 8, 15, and 22.
  • Patients will need to visit the clinic every three weeks and at the end of each cycle.
  • Patients participating in this arm will need to take medications to prevent the development of blood clots.
  • Patients in this arm will need to have an eye exam during cycle 4, and then every 6 months.

Patients will receive the study drugs until they decide to stop participating, their myeloma gets worse, they develop bad side effects, die, or the study ends. If you stop participating in the study and your myeloma has not gotten worse, you will be asked to participate in follow up visits every 3 weeks. If you stop participating in the study and your myeloma has gotten worse, you will be asked to participate in a phone or email follow-up communication every 3 months until the end of the study.


Additional Trial Information

Phase 3

Enrollment: 320 patients (estimated)

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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. Create your account or call us today for help (888) 828-2206.

  • Patients must have had at least two prior lines of therapy
  • Patients must have had an autologous stem cell transplant greater than 100 days before beginning this trial, or be ineligible to receive an autologous transplant.
  • Patients must have adequate bone marrow, liver, kidney and cardiac function.
  • Patients must not have had prior exposure to a BCMA targeted therapy.
  • Patients must not have had a prior allogeneic stem cell transplant.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Arizona Clinical Research Center, Inc.

Tucson, AZ

Open and Accepting

California

Ridley-Tree Cancer Center

Santa Barbara, CA

Open and Accepting

Colorado

Rocky Mountain Cancer Centers Pueblo

Pueblo, CO

Open and Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Open and Accepting

Nebraska

Nebraska Cancer Specialists (Omaha)

Omaha, NE

Open and Accepting

Nevada

Comprehensive Cancer Centers of Nevada (Central Valley)

Paradise, NV

Open and Accepting

New York

New York Oncology Hematology

Albany, NY

Open and Accepting

Clinical Research Alliance

Lake Success, NY

Not Yet Accepting

Ohio

Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Open and Accepting

Oregon

Samaritan Hematology and Oncology Consultants

Corvallis, OR

Open and Accepting

Willamette Valley Cancer Institute (Eugene)

Eugene, OR

Open and Accepting

Texas

Texas Oncology Presbyterian Cancer Center Dallas

Dallas, TX

Open and Accepting

Mary Crowley Cancer Research Centers

Dallas, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting

West Virginia

West Virginia University

Morgantown, WV

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting

Trial Links

Read the latest news and updates on this trial.

FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma

July 14, 2020

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

Read more
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