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Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

PHASE3RECRUITING

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years.

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Study details:

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

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Eligibility criteria

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

Inclusion criteria

  • Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
  • Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
  • History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
  • Partial Response or better according to IMWG criteria at the time of randomization
  • Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  • Not pregnant and willing to use contraception
  • Exclusion criteria

  • Plasma cell leukemia
  • Amyloidosis, Waldenström's macroglobulinemia
  • POEMS syndrome
  • Known active CNS involvement or clinical signs of myelomatous meningeal involvement
  • Previous MM maintenance treatment
  • Prior treatment with BCMA targeted therapy
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
  • Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
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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: 2022-03-25

    Primary completion: 2027-08-04

    Study completion finish: 2029-10-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05317416

    Intervention or treatment

    DRUG: Elranatamab

    DRUG: Lenalidomide

    DRUG: Lenalidomide

    DRUG: Elranatamab

    Conditions

    • Multiple Myeloma

    Find a site

    Closest Location:

    Wollongong Hospital

    Research sites nearby

    Select from list below to view details:

    • Wollongong Hospital

      Wollongong, New South Wales, Australia

    • Pindara Private Hospital

      Benowa, Queensland, Australia

    • Princess Alexandra Hospital

      Woolloongabba, Queensland, Australia

    • Shoalhaven District Memorial Hospital

      Nowra, New South Wales, 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: Arm A - Part 1
    • Elranatamab
    DRUG: Elranatamab
    • BCMA-CD3 bispecific antibody
    ACTIVE_COMPARATOR: Arm B - Part 1
    • Lenalidomide
    DRUG: Lenalidomide
    • Immunomodulatory drug
    ACTIVE_COMPARATOR: Arm B - Part 2
    • Lenalidomide
    DRUG: Lenalidomide
    • Immunomodulatory drug
    EXPERIMENTAL: Arm C - Part 2
    • Elranatamab
    DRUG: Elranatamab
    • BCMA-CD3 bispecific antibody

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Progression Free SurvivalProgression Free Survival assessed by Blinded Independent Central review per IMWG response criteriaAssessed for up to approximately 5 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Overall SurvivalDefined as the time from randomization until death due to any causeAssessed for up to approximately 5 years
    Minimal Residual Disease negativity rateMinimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing12 months after randomization
    Sustained MRD negativity rateSustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing24 months after randomization
    Progression Free SurvivalProgression Free Survival by investigator per IMWG response criteriaAssessed for up to approximately 5 years
    Overall minimal residual disease negativity rateMinimal residual disease negativity rate per IMWG criteriaAssessed for up to approximately 5 years
    Duration of minimal residual disease negativityMinimal residual disease negativity per IMWG criteriaAssessed for up to approximately 5 years
    Sustained minimal residual disease negativity rateMinimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 monthsAssessed for up to approximately 5 years
    Complete response rateComplete response rate by blinded independent central review and by investigator per IMWG criteriaAssessed for up to approximately 5 years
    Duration of complete responseDuration of complete response by blinded independent central review and by investigator per IMWG criteriaAssessed for up to approximately 5 years
    Frequency of adverse eventsAdverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study interventionUp to 90 days after last dose
    Frequency of laboratory abnormalitiesNot SpecifiedAssessed for up to approximately 5 years
    Pre-dose concentrations of elranatamabPharmacokinetics of elranatamab (trough concentrations of elranatamab)Assessed for up to approximately 5 years
    Post-dose concentrations of elranatamabPharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"Assessed for up to approximately 5 years
    Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamabImmunogenicity of elranatamabAssessed for up to approximately 5 years
    Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptomsAssessed for up to approximately 5 years
    Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptomsAssessed for up to approximately 5 years
    Progression Free Survival 2Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteriaAssessed for up to approximately 5 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

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