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 1

Enrollment: 534 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arkansas

Highlands Oncology Group

Springdale, AR

Not Yet Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Not Yet Accepting

Mississippi

Forrest General Cancer Center

Hattiesburg, MS

Not Yet Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Not Yet Accepting

Pennsylvania

Main Line Health Lankenau Medical Center

Wynnewood, PA

Not Yet Accepting

South Carolina

Charleston Hematology Oncology Associates PA West Ashley

Charleston, SC

Not Yet Accepting

Gibbs Cancer Center and Research Spartanburg Regional Healthcare System

Spartanburg, SC

Not Yet Accepting

Utah

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, UT

Not Yet Accepting

Wisconsin

UW Cancer Center at ProHealth Care

Waukesha, WI

Not Yet Accepting
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