Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
MagnetisMM15
ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
2 other identifiers
interventional
80
5 countries
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 multiple-myeloma
Started Oct 2023
Longer than P75 for phase_4 multiple-myeloma
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
October 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 22, 2032
May 5, 2026
May 1, 2026
8.4 years
September 5, 2023
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
A minimum of 90 days after the last dose of study drug
Incidence of serious adverse events (SAEs)
A minimum of 90 days after the last dose of study drug
Study Arms (1)
Elranatamab
EXPERIMENTALElranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Interventions
Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (15)
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
UCHealth Harmony
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80634, United States
Longs Peak Hospital
Longmont, Colorado, 80504, United States
UCHealth Longs Peak Medical Center
Longmont, Colorado, 80504, United States
UCHealth - Medical Center of the Rockies
Loveland, Colorado, 80538, United States
University of Miami Hospital and Clinics Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Hospital and Clinics - Griffin Cancer Research Building
Miami, Florida, 33136, United States
St. David's South Austin Medical Center
Austin, Texas, 78704, United States
Slade Pharmacy
Richmond, Victoria, 3121, Australia
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510555, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
National Taiwan University Hospital
Taipei, 10002, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2023
First Posted
September 28, 2023
Study Start
October 3, 2023
Primary Completion (Estimated)
February 22, 2032
Study Completion (Estimated)
February 22, 2032
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.