Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
Primary Purpose
Multiple Myeloma
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
REGN5458
Sponsored by
About this trial
This is an expanded access trial for Multiple Myeloma focused on measuring Relapsed, Refractory
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05164250
First Posted
December 9, 2021
Last Updated
June 27, 2023
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05164250
Brief Title
Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
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
Regeneron Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma
Detailed Description
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed, Refractory
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
REGN5458
Other Intervention Name(s)
BCMAxCD3, linvoseltamab
10. Eligibility
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Requests for compassionate use must be initiated by a treating physician. Physicians should contact
Phone
844-734-6643
Email
CompassionateUserRequests@regeneron.com
12. IPD Sharing Statement
Learn more about this trial
Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
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