Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM). EXCALIBER
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What's the purpose of this trial?

This is a multicenter, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

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


What will happen during the trial?

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.

Inclusion Criteria:

  • Participant is ≥ 18 years of age
  • Participant has documented diagnosis of multiple myeloma (MM) and measurable disease:
    • M-protein quantities ≥ 1 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP); or
    • Light chain MM without measurable disease in serum or urine: serum free light chain (FLC) levels ≥ 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio
  • Participant has received 1 to 2 prior lines of anti-myeloma therapy.
  • Participant achieved a response (partial response [PR] or better) to at least 1 prior anti-myeloma regimen.
  • Participant must have documented disease progression during or after their last anti-myeloma regimen.
  • Prior treatment with CD38-directed therapy is permitted only if all the following are fulfilled:
    • Best response achieved during CD38-directed therapy was ≥ PR.
    • Participant did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy.
    • Participant did not discontinue CD38-directed therapy due to a related AE.
    • Last dose of daratumumab was ≥ 3 months prior to randomization.
  • Prior treatment with bortezomib therapy is permitted, if all the following are fulfilled:
    • Best response achieved during bortezomib therapy was at least a minimal response (MR).
    • Participant did not progress while receiving bortezomib therapy or within 60 days of last dose of therapy
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Exclusion Criteria:

  • Participant has any of the following laboratory abnormalities:
    • Absolute neutrophil count (ANC) < 1,000/µL.
    • Platelet count: < 75,000/µL for participants in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/µL for participants in whom ≥ 50% of bone marrow nucleated cells are plasma cells
    • Hemoglobin < 8 g/dL (< 4.9 mmol/L).
    • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 or requiring dialysis.
    • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L).
    • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN).
    • Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome.
  • Participant has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
  • Participant has peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain.
  • Participant has prior history of malignancies, other than MM.
  • Participant with known central nervous system involvement with MM.

Additional Trial Information

Phase 3

Enrollment: 742 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Florida

Advent Health Medical Group Blood & Marrow Transplant

Orlando, FL

Not Yet Accepting

Florida Cancer Specialists North

St. Petersburg, FL

Not Yet Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Not Yet Accepting

Louisiana

Hematology/Oncology Clinic LLP

Baton Rouge, LA

Not Yet Accepting

Maryland

American Oncology Partners of Maryland, PA

Bethesda, MD

Not Yet Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

University of Massachusetts Medical School

Worcester, MA

Not Yet Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Not Yet Accepting

Summit Medical Group MD Anderson Cancer Center

Florham Park, NJ

Not Yet Accepting

New York

NYU Winthrop Hospital

Mineola, NY

Not Yet Accepting

NewYork-Presbyterian/ Weill Cornell Medical Center

New York, NY

Not Yet Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Not Yet Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Not Yet Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Pennsylvania

Allegheny Health Network (West Penn)

Pittsburgh, PA

Not Yet Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Not Yet Accepting

Texas

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Not Yet Accepting
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