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Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

PHASE4RECRUITING

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

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Study details:

This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

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Eligibility criteria

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

Inclusion criteria

  • Participants must agree to follow the reproductive criteria as outlined in the protocol
  • Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).
  • Exclusion criteria

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.
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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: 2023-10-03

    Primary completion: 2031-02-22

    Study completion finish: 2031-02-22

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE4

    trial

    Trial ID

    NCT06057402

    Intervention or treatment

    DRUG: Elranatamab

    Conditions

    • Multiple Myeloma

    Find a site

    Closest Location:

    Epworth Freemasons

    Research sites nearby

    Select from list below to view details:

    • Epworth Freemasons

      Melbourne, Victoria, Australia

    • Epworth Hospital

      Richmond, Victoria, Australia

    • Slade Pharmacy

      Richmond, 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: Elranatamab
    • Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
    DRUG: Elranatamab
    • Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence of nonserious adverse events (AEs) leading to permanent discontinuationNot SpecifiedA minimum of 90 days after the last dose of study drug
    Incidence of serious adverse events (SAEs)Not SpecifiedA minimum of 90 days after the last dose of study drug

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

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