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 is an upcoming trial that has not yet started accepting patients.


What's being studied?

  • Dexamethasone is a steroid given in conjunction with some cancer treatments.
  • Isatuximab is an anti-CD38 monoclonal antibody.
  • Lenalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

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:

ILd Arm – Isatuximab, Lenalidomide and Dexamethasone

Isatuximab, given by intravenous infusion:

    • Cycle 1: Days 1, 8, 15, and 22 of 28 day cycle
    • Cycles 2-12: Days 1 and 15 of each 28 day cycle
    • Cycles 13-36: Day 1 of each 28 day cycle

Lenalidomide, given orally:

    • Cycles 1-9: Days 1-21 of each 28 day cycle
    • Cycles 10-24: Days 1-21 of each 28 day cycle at reduced dose level

Dexamethasone, given intravenously on cycle 1 day 1, then orally.

    • Cycle 1-9: Days 1, 8, 15 and 22 of each 28 day cycle
    • Cycle 10-24: Days 1, 8, 15 and 22 of each 28 day cycle at reduced dose level.

Ld Arm – Lenalidomide and Dexamethasone

Lenalidomide, given orally:

    • Cycles 1-9: Days 1-21 of each 28 day cycle
    • Cycles 10-24: Days 1-21 of each 28 day cycle at reduced dose level

Dexamethasone, given intravenously on cycle 1 day 1, then orally.

    • Cycle 1-9: Days 1, 8, 15 and 22 of each 28 day cycle
    • Cycle 10-24: Days 1, 8, 15 and 22 of each 28 day cycle at reduced dose level.

Additional Trial Information

Phase 3

Enrollment: 323 patients (estimated)

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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. Create your account or call us today for help (888) 828-2206.

  • 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.
View Additional Criteria

Trial Locations

This trial is not yet recruiting patients in the US. For additional information, please call SparkCures at (888) 828-2206.

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Not Yet Accepting

California

UCLA Medical Center, Santa Monica UCLA Health

Santa Monica, CA

Not Yet Accepting

Colorado

Florida

Cancer Specialists of North Florida

Fleming Island, FL

Not Yet Accepting

Florida Cancer Specialists South

Fort Myers, FL

Not Yet Accepting

Florida Cancer Specialists North

St. Petersburg, FL

Not Yet Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Not Yet Accepting

North Carolina

Presbyterian Hospital Novant Health

Charlotte, NC

Not Yet Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Not Yet Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting
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