- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06057402
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM) (MagnetisMM15)
June 4, 2026 updated by: Pfizer
ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.
Study Overview
Detailed Description
This is a single-arm elranatamab post-trial access study.
Participants will receive elranatamab.
All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3002
- Recruiting
- Epworth Freemasons
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Richmond, Victoria, Australia, 3121
- Recruiting
- Slade Pharmacy
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Richmond, Victoria, Australia, 3121
- Recruiting
- Epworth Hospital
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Alberta
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Calgary, Alberta, Canada, T2N 5GN
- Recruiting
- Arthur J.E. Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Recruiting
- Cross Cancer Institute
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Recruiting
- McGill University Health Centre
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Active, not recruiting
- Peking University Third Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510555
- Active, not recruiting
- Sun Yat-sen University Cancer Center
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Shandong
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Jinan, Shandong, China, 250021
- Recruiting
- Shandong Provincial Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital, Zhejiang University School of Medicine
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Kyoto, Japan, 602-8566
- Recruiting
- University Hospital,Kyoto Prefectural University of Medicine
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Tokyo
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Shibuya-ku, Tokyo, Japan, 150-8935
- Recruiting
- Japanese Red Cross Medical Center
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Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Recruiting
- Taipei Veterans General Hospital
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Colorado
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Fort Collins, Colorado, United States, 80524
- Recruiting
- UCHealth Poudre Valley Hospital
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Fort Collins, Colorado, United States, 80528
- Recruiting
- UCHealth Harmony
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Greeley, Colorado, United States, 80634
- Recruiting
- UCHealth Greeley Hospital
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Longmont, Colorado, United States, 80504
- Recruiting
- Longs Peak Hospital
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Longmont, Colorado, United States, 80504
- Recruiting
- UCHealth Longs Peak Medical Center
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Loveland, Colorado, United States, 80538
- Recruiting
- UCHealth - Medical Center of the Rockies
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Florida
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Coral Gables, Florida, United States, 33146
- Recruiting
- Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
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Deerfield Beach, Florida, United States, 33442
- Recruiting
- University of Miami Hospital and Clinics Deerfield Beach
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Miami, Florida, United States, 33136
- Recruiting
- Sylvester Comprehensive Cancer Center
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami Hospital and Clinics
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami Hospital and Clinics - Griffin Cancer Research Building
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
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Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
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Texas
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Austin, Texas, United States, 78704
- Recruiting
- St. David's South Austin Medical Center
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants must agree to follow the reproductive criteria as outlined in the protocol
- Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).
Exclusion Criteria:
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.
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?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Elranatamab
Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
|
Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
Time Frame: A minimum of 90 days after the last dose of study drug
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A minimum of 90 days after the last dose of study drug
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Incidence of serious adverse events (SAEs)
Time Frame: A minimum of 90 days after the last dose of study drug
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A minimum of 90 days after the last dose of study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start (Actual)
October 3, 2023
Primary Completion (Estimated)
February 22, 2032
Study Completion (Estimated)
February 22, 2032
Study Registration Dates
First Submitted
September 5, 2023
First Submitted That Met QC Criteria
September 21, 2023
First Posted (Actual)
September 28, 2023
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 4, 2026
Last Verified
June 1, 2026
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
- Hemic and Lymphatic Diseases
- Multiple Myeloma
Other Study ID Numbers
- C1071015
- 2023-505200-33-00 (Registry Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.
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-
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-
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-
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-
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