Back to resultsPre-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
About this trial
This is an expanded access trial for Multiple Myeloma focused on measuring refractory, relapsed
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05238311
First Posted
February 3, 2022
Last Updated
October 12, 2023
Sponsor
Pfizer
Collaborators
In Expanded Access, treating physicians are the Sponsors
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
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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
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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