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NCT Number: NCT04975997

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 080, Ciudad Autanoma de Buenos Aires, Buenos Aires, Argentina

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About this study

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). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:

  • Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
  • Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dexamethasone

Drug

Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

Daratumumab

Drug

Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle

Other names: DARZALEX FASPRO

bortezomib

Drug

Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.

Iberdomide

Drug

Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle

Other names: CC-220, BMS-986382

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: 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

    Time frame: 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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 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

    Time frame: Up to approximately 5 years

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

  3. Overall Response Rate (ORR)

    Time frame: 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)

    Time frame: Up to approximately 5 years

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

  5. Duration of Response (DoR)

    Time frame: 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)

    Time frame: Up to approximately 5 years

    The time from randomization to the first documented disease progression.

  7. Time to Next Treatment (TTNT)

    Time frame: Up to approximately 5 years

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

  8. Progression-free Survival 2 (PFS2)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: Up to approximately 1 year

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

    Time frame: Up to approximately 1 year

  14. Maximum plasma concentration (Cmax)

    Time frame: Up to approximately 1 year

  15. Time to maximum plasma concentration (Tmax)

    Time frame: Up to approximately 1 year

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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)

Acronym: EXCALIBER-RRMM

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Jul 26, 2021
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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