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

PHASE3RECRUITING

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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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-06-23

    Primary completion: 2026-03-18

    Study completion finish: 2032-06-25

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT04975997

    Intervention or treatment

    DRUG: Dexamethasone

    DRUG: Daratumumab

    DRUG: Bortezomib

    DRUG: Iberdomide

    DRUG: Iberdomide

    DRUG: Iberdomide

    Conditions

    • Multiple Myeloma

    Find a site

    Closest Location:

    Sunshine Coast University Hospital

    Research sites nearby

    Select from list below to view details:

    • Sunshine Coast University Hospital

      Birtinya, Queensland, Australia

    • Royal Adelaide Hospital

      Adelaide, South Australia, Australia

    • Monash Medical Centre

      Clayton, Victoria, Australia

    • The Alfred Hospital

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
    • Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
    DRUG: Dexamethasone
    • Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
    EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
    • Not Specified
    DRUG: Dexamethasone
    • Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
    EXPERIMENTAL: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
    • Not Specified
    DRUG: Dexamethasone
    • Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
    ACTIVE_COMPARATOR: Daratumumab in combination with dexamethasone and bortezomib
    • Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
    DRUG: Dexamethasone
    • Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Progression-free Survival (PFS)To compare the efficacy of iberdomide, daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in terms of progression-free survival (PFS) in participants with relapsed or refractory multiple myeloma (RRMM).Up to approximately 5 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Overall Survival (OS)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).Up to approximately 5 years
    Minimal Residual Disease (MRD) negativity rateProportion of participants who achieve complete response (CR) or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells by next generation flow cytometry).Up to approximately 5 years
    Overall Response Rate (ORR)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.Up to approximately 5 years
    Time to response (TTR)Time from randomization to the first documentation of response (PR or better).Up to approximately 5 years
    Duration of Response (DoR)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.Up to approximately 5 years
    Time to Progression (TTP)The time from randomization to the first documented disease progression.Up to approximately 5 years
    Time to Next Treatment (TTNT)Time from randomization to the start of the next antimyeloma treatment.Up to approximately 5 years
    Progression-free Survival 2 (PFS2)Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.Up to approximately 5 years
    SafetyType, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.Up to approximately 5 years
    European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)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.Up to approximately 5 years
    European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)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.Up to approximately 5 years
    Recommended iberdomide dose for Stage 2Not SpecifiedUp to approximately 1 year
    Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))Not SpecifiedUp to approximately 1 year
    Maximum plasma concentration (Cmax)Not SpecifiedUp to approximately 1 year
    Time to maximum plasma concentration (Tmax)Not SpecifiedUp to approximately 1 year

    Frequently Asked Questions

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    References

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

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