Phase 3 Clinical Trial Studying Isatuximab in combination with Lenalidomide and Dexamethasone in High Risk Smoldering Multiple Myeloma ITHACA
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What's the purpose of this trial?

The goal of this clinical trial is to evaluate the effectiveness and risks of isatuximab in combination with lenalidomide and dexamethasone compared to lenalidomide and dexamethasone alone.

This trial is currently open and accepting patients.

What will happen during the trial?

This clinical trial is seeking approximately 300 patients who will be randomly placed into two different groups (or arms). One group will receive isatuximab in combination with lenalidomide and dexamethasone (ILd arm), and the other will receive lenalidomide and dexamethasone (Ld arm).

Patients joining this clinical trial will receive the study drugs for 36 cycles in the ILd arm, and 24 cycles in the Ld arm. Both patients and their providers will know which group they are placed in, and which drugs they will receive. Both arms are organized into 28 day cycles.

The dosing schedules for each arm are as follows:

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 been diagnosed with smoldering multiple myeloma in the last 5 years.
  • Meet measurable disease criteria as described in the trial protocol.
  • Meet high risk smoldering multiple myeloma criteria as described in the trial protocol.
  • Have adequate bone marrow, liver, kidney and cardiac function as described in the trial protocol.
  • Do not have amyloidosis.
  • Have not had treatment resistant peptic ulcer disease, erosive esophagitis/gastritis, or infectious/inflammatory irritable bowel disease in the past three months.
  • Have not had prior exposure to approved or unapproved therapies for smoldering multiple myeloma.
  • Are not undergoing treatment with corticosteroids.
  • Have not received vaccination with a live vaccine in the 4 weeks before joining.

Additional Trial Information

Phase 3

Enrollment: 323 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

UCLA Medical Center, Santa Monica UCLA Health

Santa Monica, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Florida

Florida Cancer Specialists South

Fort Myers, FL

Not Yet Accepting

Cancer Specialists of North Florida

Jacksonville, FL

Open and Accepting

Sylvester Comprehensive Cancer Center University of Miami Health System

Miami, FL

Open and Accepting

Florida Cancer Specialists North

St. Petersburg, FL

Not Yet Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

North Carolina

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Not Yet Accepting

Novant Health Forsyth Cancer Institute - Bethesda Court

Winston-Salem, NC

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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