Phase 3 Study Evaluating Subcutaneous vs Intravenous Isatuximab in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma IRAKLIA

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 Oncology Associates, PC (Prescott Valley)

Prescott Valley, AZ

Open and Accepting


Rocky Mountain Cancer Centers (Aurora) Aurora

Aurora, CO

Open and Accepting


Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting


Forrest General Cancer Center

Hattiesburg, MS

Open and Accepting


Comprehensive Cancer Centers of Nevada (Central Valley)

Las Vegas, NV

Not Yet Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Not Yet 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


Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Open and Accepting


Willamette Valley Cancer Institute (Eugene)

Eugene, OR

Open and Accepting

South Carolina

Gibbs Cancer Center and Research Spartanburg Regional Healthcare System

Spartanburg, SC

Not Yet Accepting

Spartanburg Medical Center

Spartanburg, SC

Open and Accepting


Texas Oncology - Sammons Cancer Center

Dallas, TX

Open and Accepting

Texas Oncology - San Antonio Medical Center

San Antonio, TX

Open and Accepting


George E. Wahlen VA Medical Center

Salt Lake City, UT

Open and Accepting


UW Cancer Center at ProHealth Care

Waukesha, WI

Open and Accepting
Interested in this trial?
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