Phase 3 Study Evaluating Subcutaneous vs Intravenous Isatuximab in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma IRAKLIA
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What's the purpose of this trial?

The goal of this clinical trial is to learn more about the safety and effectiveness of isatuximab given by subcutaneous injection versus intravenous infusion. Both subcutaneous and intravenous isatuximab will be studied in combination with pomalidomide and dexamethasone in patients who have relapsed and/or refractory multiple myeloma.

This trial is currently open and accepting patients.


What will happen during the trial?

This clinical trial is organized into 28 day cycles. This trial is seeking to enroll approximately 534 patients into one of two arms. Participants will be randomly assigned into one of the two arms. Patients can continue to participate in this study until their myeloma gets worse, or they experience bad side effects. 

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 measurable disease according to the trial criteria.
  • have received at least one prior line of therapy for your myeloma, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor. These may have been given alone or in combination.
  • have received only one prior line of therapy and must be refractory to lenalidomide.
  • have not previously had treatment with pomalidomide.
    must not have active GVHD after a previous allogeneic stem cell transplant.
  • must have adequate bone marrow, kidney, cardiac and liver function as described in the trial protocol. 

Additional Trial Information

Phase 3

Enrollment: 534 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Mohtaseb Cancer Center and Blood Disorders Hancock Medical Plaza

Bullhead City, AZ

Open and Accepting

Arizona Oncology Associates, PC (Prescott Valley)

Prescott Valley, AZ

Open and Accepting

Colorado

Rocky Mountain Cancer Centers

Aurora, CO

Open and Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Boca Raton Clinical Research (BRCR) Medical Center

Plantation, FL

Open and Accepting

Maryland

Mississippi

Forrest General Cancer Center

Hattiesburg, MS

Open and Accepting

Nevada

Comprehensive Cancer Centers of Nevada (Central Valley)

Las Vegas, NV

Open and Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Open and Accepting

New York

New York Oncology Hematology - Albany Cancer Center

Albany, NY

Open and Accepting

North Carolina

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Open and Accepting

Novant Health Forsyth Cancer Institute - Bethesda Court

Winston-Salem, NC

Open and Accepting

Ohio

Gabrail Cancer Center Research

Canton, OH

Open and Accepting

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Open and Accepting

Oregon

Willamette Valley Cancer Institute (Eugene)

Eugene, OR

Open and Accepting

South Carolina

Gibbs Cancer Center and Research Spartanburg Medical Center

Spartanburg, SC

Not Yet Accepting

Texas

Texas Oncology - Sammons Cancer Center

Dallas, TX

Open and Accepting

Texas Oncology - San Antonio Medical Center

San Antonio, TX

Open and Accepting

Utah

George E. Wahlen VA Medical Center

Salt Lake City, UT

Open and Accepting

Wisconsin

UW Cancer Center at ProHealth Care

Waukesha, WI

Open and Accepting
Interested in this trial?
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