Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04975997
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
939
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Lead sponsor
Celgene
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Start date
2022-06-23
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Number of sites
259
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Summary
This is a multicenter, two-stage, 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).
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Acronym
EXCALIBER-RRMM
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Short title
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
clinicaltrials.gov
Official title
A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-06-25
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First posted
2021-07-26
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Registry last updated
2026-04-03
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Primary completion date
2027-11-16
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Start date
2022-06-23
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Actual participants
939
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Participants
939
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Participant count basis
Actual
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Protocol amendments
8
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Randomisation ratio
1:1
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Number of sites
259
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Celgene
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Source registry
ClinicalTrials.gov
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Registry ID
NCT04975997
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ClinicalTrials.gov ID
NCT04975997
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Progression-free Survival (PFS)

    Timeframe: Up to approximately 5 years

    To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS).

  2. Minimal Residual Disease (MRD) negative Complete Response (CR) at any time

    Timeframe: Up to approximately 5 years

    To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time.

  1. Overall Survival (OS)

    Timeframe: Up to approximately 5 years

    To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).

  2. Sustainability of Minimal Residual Disease (MRD) negativity

    Timeframe: Up to approximately 5 years

    To evaluate the sustainability of minimal residual disease (MRD) negativity.

  3. Overall Response Rate (ORR)

    Timeframe: Up to approximately 5 years

    Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.

  4. Time to response (TTR)

    Timeframe: Up to approximately 5 years

    Time from randomization to the first documentation of response (PR or better).

  5. Duration of Response (DoR)

    Timeframe: Up to approximately 5 years

    Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.

  6. Time to Progression (TTP)

    Timeframe: Up to approximately 5 years

    The time from randomization to the first documented disease progression.

  7. Time to Next Treatment (TTNT)

    Timeframe: Up to approximately 5 years

    Time from randomization to the start of the next antimyeloma treatment.

  8. Progression-free Survival 2 (PFS2)

    Timeframe: Up to approximately 5 years

    Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.

  9. Safety

    Timeframe: Up to approximately 5 years

    Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.

  10. European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)

    Timeframe: Up to approximately 5 years

    Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.

  11. European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)

    Timeframe: Up to approximately 5 years

    EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.

  12. Recommended iberdomide dose for Stage 2

    Timeframe: Up to approximately 1 year

  13. Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))

    Timeframe: Up to approximately 1 year

  14. Maximum plasma concentration (Cmax)

    Timeframe: Up to approximately 1 year

  15. Time to maximum plasma concentration (Tmax)

    Timeframe: Up to approximately 1 year

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Documented diagnosis of multiple myeloma (MM) and measurable disease.
  • Received 1 to 2 prior lines of anti-myeloma therapy.
  • Must have documented disease progression during or after their last anti-myeloma regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

  • Any condition that confounds the ability to interpret data from the study.
  • Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
  • Known central nervous system involvement with MM.
  • Prior therapy with iberdomide.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
clinicaltrials.gov

  • Local Institution - 035Hot Springs, United States
  • Local Institution - 641Cerritos, United States
  • Local Institution - 681Fountain Valley, United States
  • Local Institution - 047Los Angeles, United States
  • Local Institution - 684Newport, United States
  • Local Institution - 033New Haven, United States
  • Local Institution - 029Fort Myers, United States
  • Local Institution - 693Ocala, United States
  • Local Institution - 028St. Petersburg, United States
  • Local Institution - 045Tamarac, United States
  • Local Institution - 034West Palm Beach, United States
  • Local Institution - 685Weston, United States
  • Local Institution - 018Atlanta, United States
  • Local Institution - 640Elk Grove Village, United States
  • Local Institution - 697Dyer, United States
  • Local Institution - 040Louisville, United States
  • Local Institution - 041Alexandria, United States
  • Local Institution - 682Baton Rouge, United States
  • Local Institution - 027Baton Rouge, United States
  • Local Institution - 698Baltimore, United States
  • Local Institution - 014Bethesda, United States
  • Local Institution - 688Columbia, United States
  • Local Institution - 010Boston, United States
  • Local Institution - 009Worcester, United States
  • Local Institution - 645Burnsville, United States

And 234 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1260-2872
  • 2020-000431-49
Sources for references
clinicaltrials.gov

Related records

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