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Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05164250
Expanded Access Status : Available
First Posted : December 20, 2021
Last Update Posted : June 28, 2023
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:
Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma

Condition or disease Intervention/treatment
Multiple Myeloma Drug: REGN5458

Detailed Description:
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Interventions
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Intervention Details:
  • Drug: REGN5458
    Other Names:
    • BCMAxCD3
    • linvoseltamab
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05164250


Contacts
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Contact: Requests for compassionate use must be initiated by a treating physician. Physicians should contact 844-734-6643 CompassionateUserRequests@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05164250    
Other Study ID Numbers: R5458-MM
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: June 28, 2023
Last Verified: June 2023
Keywords provided by Regeneron Pharmaceuticals:
Relapsed, Refractory
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases