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

PHASE3ACTIVE_NOT_RECRUITING

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.

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.

Eligibility criteria

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

Inclusion criteria

  1. Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
  2. Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
  3. 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.
  4. Partial Response or better according to IMWG criteria at the time of randomization
  5. 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.
  6. ECOG performance status ≤1
  7. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  8. Not pregnant and willing to use contraception

Exclusion criteria

  1. Plasma cell leukemia
  2. Amyloidosis, Waldenström's macroglobulinemia
  3. POEMS syndrome
  4. Known active CNS involvement or clinical signs of myelomatous meningeal involvement
  5. Previous MM maintenance treatment
  6. Prior treatment with BCMA targeted therapy
  7. 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
  8. Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
  9. 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)

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT05317416

Intervention or treatment

DRUG: Elranatamab

DRUG: Lenalidomide

DRUG: Lenalidomide

DRUG: Elranatamab

Conditions

  • Multiple Myeloma

  • Condition: Multiple Myeloma

  • DRUG: Elranatamab and other drugs

  • Camperdown, New South Wales, Australia and more

  • Sponsor: Pfizer

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Royal Prince Alfred Hospital

Select from list below to view details:

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, Australia

  • Shoalhaven District Memorial Hospital

    Nowra, New South Wales, Australia

  • Westmead Hospital

    Westmead, New South Wales, Australia

  • Wollongong Hospital

    Wollongong, New South Wales, Australia

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Who is running the clinical trial?

P

Pfizer

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
    ACTIVE_COMPARATOR: Arm B - Part 1
    • Lenalidomide
    Drug: Lenalidomide
      ACTIVE_COMPARATOR: Arm B - Part 2
      • Lenalidomide
      Drug: Lenalidomide
        EXPERIMENTAL: Arm C - Part 2
        • Elranatamab
        Drug: Elranatamab

          What is the study measuring?

          Primary Outcome

          MeasureDescriptionTime Frame
          Minimal Residual Disease negativity rateMinimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing12 months after randomization
          Progression Free SurvivalProgression Free Survival assessed by Blinded Independent Central review per IMWG response criteriaAssessed for up to approximately 5 years

          Secondary Outcome

          MeasureDescriptionTime Frame
          Overall SurvivalDefined as the time from randomization until death due to any causeAssessed for up to approximately 5 years
          Sustained MRD negative rateSustained Minimal Residual Disease negative 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 negative rateMinimal residual disease negative 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
          Severity of Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndromeCytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome severity assessed per ASH-ASTCT criteriaAssessed for up to approximately 5 years
          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
          Are you running this trial?If you're a clinic or sponsor, you can claim this study.
          Claim this trial

          References

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

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