Back to resultsPre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)
Primary Purpose
Multiple Myeloma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Teclistamab
Sponsored by
About this trial
This is an expanded access trial for Multiple Myeloma
Eligibility Criteria
Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors [PIs], immunomodulatory imide drugs [IMIDs], anti CD38 monoclonal antibodies [mAbs] and therapies targeting Exportin 1 [XPO1] and B cell maturation antigen [BCMA]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05161598
First Posted
December 3, 2021
Last Updated
August 15, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05161598
Brief Title
Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)
Official Title
PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
5. Study Description
Brief Summary
Teclistamab pre-approval access in relapsed or refractory multiple myeloma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors [PIs], immunomodulatory imide drugs [IMIDs], anti CD38 monoclonal antibodies [mAbs] and therapies targeting Exportin 1 [XPO1] and B cell maturation antigen [BCMA]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting
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
Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)
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