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Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)

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: NCT05238311
Expanded Access Status : Available
First Posted : February 14, 2022
Last Update Posted : February 28, 2023
Sponsor:
Collaborator:
In Expanded Access, treating physicians are the Sponsors
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Provide pre-approval single-patient Expanded Access (Compassionate Use) of elranatamab for patients with relapsed/refractory multiple myeloma

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Elranatamab

Detailed Description:
Expanded Access requests from treating physicians should be directed to www.pfizercares.com Availability will depend on location

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Study Type : Expanded Access
Expanded Access Type : Individual Patients




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT05238311


Contacts
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Contact: PfizerCares PfizerCares@Pfizer.com

Sponsors and Collaborators
Pfizer
In Expanded Access, treating physicians are the Sponsors
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05238311    
Other Study ID Numbers: C107
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Keywords provided by Pfizer:
refractory
relapsed
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