Phase 3 Clinical Trial Studying Isatuximab in combination with Lenalidomide and Dexamethasone in High Risk Smoldering Multiple Myeloma ITHACA

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)

View More

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


UCLA Medical Center, Santa Monica UCLA Health

Santa Monica, CA

Open and Accepting



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


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


Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting


MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message

SparkCures Verified

SparkCures is working closely with Sanofi to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.

Learn more about how we work with trial sponsors