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

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 trial is currently open and 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: 864 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


Florida Cancer Specialists South

Fort Myers, FL

Open and Accepting

Advent Health Cancer Institute (Orlando)

Orlando, FL

Not Yet Accepting

Florida Cancer Specialists North

St. Petersburg, FL

Open and Accepting


Winship Cancer Institute of Emory University

Atlanta, GA

Not Yet Accepting


Hematology Oncology Clinic

Baton Rouge, LA

Open and Accepting



Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

University of Massachusetts Medical School

Worcester, MA

Not Yet Accepting


HCA Midwest Health

Kansas City, MO

Open and Accepting

New Jersey

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


Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting


West Penn Hospital (Allegheny Health Network)

Pittsburgh, PA

Not Yet Accepting

South Dakota

Avera Cancer Institute - Sioux Falls

Sioux Falls, SD

Not Yet Accepting


Tennessee Oncology Memorial Plaza

Chattanooga, TN

Open and Accepting

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Not Yet Accepting

Tennessee Oncology Centennial Clinic

Nashville, TN

Open and Accepting



UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting
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