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Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

Primary Purpose

Relapsed or Refractory Multiple Myeloma

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Teclistamab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patient diagnosed with Relapsed or Refractory Multiple Myeloma
  • Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 1, 2022
    Last Updated
    November 9, 2022
    Sponsor
    Janssen Research & Development, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05463939
    Brief Title
    Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients
    Official Title
    Teclistamab US Expanded Access Treatment Protocol for Patients With Relapsed or Refractory Multiple Myeloma
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Approved for marketing
    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
    Janssen Research & Development, LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this expanded access treatment protocol is to provide patients access to teclistamab prior to market authorization. The program is limited to patients with relapsed or refractory multiple myeloma who have exhausted all treatment options available as local standard of care and who are not eligible for a teclistamab clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsed or Refractory Multiple Myeloma

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Teclistamab
    Other Intervention Name(s)
    JNJ-64007957
    Intervention Description
    Teclistamab will be administered subcutaneously (SC).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patient diagnosed with Relapsed or Refractory Multiple Myeloma Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Research & Development, LLC Clinical Trial
    Organizational Affiliation
    Janssen Research & Development, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

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