Phase 3 Clinical Trial Comparing the Safety and Effectiveness of Iberdomide, Daratumumab and Dexamethasone VS Daratumumab, Bortezomib, and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma EXCALIBER RRMM
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What's the purpose of this trial?

The goal of this clinical trial is to find the optimal dose of investigational drug iberdomide in combination with daratumumab and dexamethasone, and to study whether investigational drug iberdomide works in treating relapsed or refractory multiple myeloma when combined with daratumumab and dexamethasone.

This trial is currently open and accepting patients.

What will happen during the trial?

STAGE 1
Participants in this stage will be randomly assigned into one of four groups. Three of the groups will receive different doses of investigational drug Iberdomide in combination with Daratumumab and Dexamethasone. One group will receive comparator combination of Daratumumab, Bortezomib, and Dexamethasone. The three Iberdomide groups will receive different doses of investigational drug Iberdomide.

STAGE 2
Participants in this stage will be randomized into one of two groups. Group A will receive investigational drug Iberdomide (at the dose selected by stage 1), Daratumumab, and Dexamethasone. Group B will receive the comparator combination of Daratumumab, Bortezomib, and Dexamethasone. 

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 as defined by the trial criteria.
  • have received one to two prior lines of anti-myeloma therapy.
  • have achieved a partial response or better to at least one prior anti-myeloma regimen.
  • have not previously received treatment with a CD-38 directed therapy (for Stage 1 participants). For Stage 2 participants, previous CD-38 therapy is allowed if while receiving it you:
    • achieved at least a partial response,
    • your myeloma did not progress while receiving it, 
    • and your last dose of Daratumumab was more than three months prior to joining the study.
  • Previous treatment with Bortezomib is allowed as long as you:
    • achieved at least a minimal response, and 
    • you did not progress while receiving Bortezomib or within 60 days of your last dose.
  • do not have central nervous system involvement of your myeloma.
  • have not previously received treatment with investigational drug Iberdomide.
  • have not previously received an allogeneic stem cell transplant, and have not received an autologous stem cell transplant in the last three months.
  • have adequate bone marrow, liver, cardiac and lung function as described in the trial criteria.

Additional eligibility criteria apply and can be explained by the study doctor. 

Additional Trial Information

Phase 3

Enrollment: 864 patients (estimated)

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Interested in joining or learning more about this trial?

(888) 828-2206

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Compassionate Cancer Care

Fountain Valley, CA

Open and Accepting

USC Norris Comprehensive Cancer Center - Keck School of Medicine University of Southern California

Los Angeles, CA

Open and Accepting

The Oncology Institute of Hope and Innovation - Whittier

Whittier, CA

Not Yet Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Florida

Ocala Oncology Center

Ocala, FL

Open and Accepting

Boca Raton Clinical Research (BRCR) Medical Center

Plantation, FL

Open and Accepting

Cleveland Clinic Florida

Weston, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Illinois

Ascension Alexian Brothers

Elk Grove Village, IL

Open and Accepting

Indiana

Northwest Cancer Center

Dyer, IN

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Louisiana

Christus St. Frances Cabrini Hospital

Alexandria, LA

Open and Accepting

Our Lady of the Lake Regional Medical Center

Baton Rouge, LA

Open and Accepting

Maryland

GBMC Cancer Center - Berman Cancer Institute

Baltimore, MD

Open and Accepting

American Oncology Partners of Maryland (Bethesda) The Center for Cancer & Blood Disorders - Bethesda

Bethesda, MD

Open and Accepting

Maryland Oncology Hematology (Columbia)

Columbia, MD

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

University of Massachusetts Medical School

Worcester, MA

Open and Accepting

Minnesota

Minnesota Oncology - Burnsville

Burnsville, MN

Open and Accepting

Missouri

HCA Midwest Health Research Medical Center

Kansas City, MO

Open and Accepting

Montana

SCL Health St. Vincent Healthcare SCL Health

Billings, MT

Open and Accepting

New York

Manhattan Hematology Oncology Associates

New York, NY

Open and Accepting

North Carolina

Duke Cancer Center Duke University Medical Center

Durham, NC

Recruitment on Hold

Ohio

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Not Yet Accepting

TriHealth Bethesda North Hospital

Cincinnati, OH

Open and Accepting

MetroHealth Medical Center

Cleveland, OH

Open and Accepting

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

OhioHealth Grant Medical Center

Columbus, OH

Open and Accepting

Oklahoma

Oklahoma Cancer Specialists and Research Institute (Tulsa)

Tulsa, OK

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Tennessee

Tennessee Oncology Memorial Plaza

Chattanooga, TN

Open and Accepting

Sarah Cannon Research Institute at Tennessee Oncology TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

Texas Oncology - Austin Midtown

Austin, TX

Open and Accepting

Kelsey-Seybold Clinic - Berthelsen

Houston, TX

Open and Accepting

Virginia

Virginia Oncology Associates

Newport News, VA

Open and Accepting

Blue Ridge Cancer Care (Roanoke)

Roanoke, VA

Open and Accepting

Wisconsin

University of Wisconsin - Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting
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