- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238311
Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)
January 31, 2025 updated by: Pfizer
Provide pre-approval single-patient Expanded Access (Compassionate Use) of elranatamab for patients with relapsed/refractory multiple myeloma
Study Overview
Detailed Description
In Expanded Access, treating physicians are the Sponsors
Expanded Access requests from treating physicians should be directed to www.pfizercares.com Availability will depend on location.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 3, 2022
First Submitted That Met QC Criteria
February 3, 2022
First Posted (Actual)
February 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 31, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Multiple Myeloma
Other Study ID Numbers
- C107
- NCT05238311 (Registry Identifier: ClinicalTrials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Zhongshan Hospital (Xiamen), Fudan UniversityNot yet recruitingMultiple Myeloma Progression | Multiple Myeloma Refractory
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University Health Network, TorontoNot yet recruitingMultiple Myeloma in Relapse | Multiple Myeloma RefractoryCanada
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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Second Affiliated Hospital, School of Medicine,...Tongji Hospital; Jinhua Municipal Central Hospital; Taizhou Hospital of Zhejiang...RecruitingRelapse Multiple MyelomaChina
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Guangzhou Bio-gene Technology Co., LtdWithdrawnMultiple Myeloma Refractory
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Elranatamab
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Peking University People's HospitalPfizerNot yet recruiting
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Stichting European Myeloma NetworkPfizerRecruitingSmoldering Multiple MyelomaNetherlands, France, Italy, Greece, Finland, Norway
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M.D. Anderson Cancer CenterPfizerRecruitingElranatamab | PMD | Relapsed Refractory Multiple Myeloma (RRMM) | Extramedullary Disease in Multiple Myeloma | Phase 2 | Radiotherapy-Induced Immune Priming | Paramedullary DiseaseUnited States
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H. Lee Moffitt Cancer Center and Research InstitutePfizerRecruitingMyelomaUnited States
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University of California, San DiegoRecruiting
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Brigham and Women's HospitalRecruiting
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Case Comprehensive Cancer CenterNot yet recruitingAmyloid Light-chain AmyloidosisUnited States
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Thomas LundPfizer; Vejle HospitalRecruitingMultiple MyelomaDenmark
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PfizerRecruitingMultiple MyelomaCanada, United States, Taiwan, China, Australia, Japan
-
Ontario Clinical Oncology Group (OCOG)Pfizer; McMaster UniversityRecruitingRefractory Multiple MyelomaCanada