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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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arkansas

Genesis Cancer and Blood Institute American Oncology Partners

Hot Springs, AR

Open and Accepting

California

Samuel Oschin Comprehensive Cancer Institute - Cedars-Sinai Medical Center

Los Angeles, CA

Not Yet Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Not Yet Accepting

Kentucky

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

Louisville, KY

Not Yet Accepting

Louisiana

Christus St. Frances Cabrini Hospital

Alexandria, LA

Not Yet Accepting

Hematology Oncology Clinic

Baton Rouge, LA

Open and Accepting

Maryland

Massachusetts

Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting

University of Massachusetts Medical School

Worcester, MA

Open and Accepting

Missouri

HCA Midwest Health

Kansas City, MO

Open and Accepting

Montana

SCL Health St. Vincent Healthcare SCL Health

Billings, MT

Not Yet Accepting

New York

New York Cancer & Blood Specialists (Bay Shore)

Bay Shore, NY

Not Yet Accepting

North Carolina

Duke Cancer Center Duke University Medical Center

Durham, NC

Not Yet Accepting

Ohio

TriHealth Bethesda North Hospital

Cincinnati, OH

Open and Accepting

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

MetroHealth Medical Center

Cleveland, OH

Not Yet Accepting

OhioHealth Grant Medical Center

Columbus, OH

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Not Yet Accepting

Tennessee

Tennessee Oncology Memorial Plaza

Chattanooga, TN

Open and Accepting

Sarah Cannon Tennessee Oncology- Nashville (24th Ave) Centennial Clinic

Nashville, TN

Open and Accepting

Wisconsin

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