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Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)

Primary Purpose

Multiple Myeloma

Status
Temporarily not available
Phase
Locations
Study Type
Expanded Access
Intervention
Elranatamab
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Multiple Myeloma focused on measuring refractory, relapsed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes
Must have relapsed/refractory multiple myeloma (RRMM) and be refractory to at least one immunomodulatory drug, one proteasome inhibitor and one anti-CD38 antibody. Must have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care and not be eligible for participation in any ongoing clinical trial. Additional eligibility criteria may be required.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2022
    Last Updated
    October 12, 2023
    Sponsor
    Pfizer
    Collaborators
    In Expanded Access, treating physicians are the Sponsors
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05238311
    Brief Title
    Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Temporarily not available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer
    Collaborators
    In Expanded Access, treating physicians are the Sponsors

    4. Oversight

    5. Study Description

    Brief Summary
    Provide pre-approval single-patient Expanded Access (Compassionate Use) of elranatamab for patients with relapsed/refractory multiple myeloma
    Detailed Description
    Expanded Access requests from treating physicians should be directed to www.pfizercares.com Availability will depend on location.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    refractory, relapsed

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Elranatamab

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Must have relapsed/refractory multiple myeloma (RRMM) and be refractory to at least one immunomodulatory drug, one proteasome inhibitor and one anti-CD38 antibody. Must have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care and not be eligible for participation in any ongoing clinical trial. Additional eligibility criteria may be required.

    12. IPD Sharing Statement

    Learn more about this trial

    Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)

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