Back to resultsElranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM) (MagnetisMM15)
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Elranatamab
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Elranatamab, Post Trial Access, Roll-over Study, Extension Study, MM-15, MagnetisMM15, BCMA, BCMA antibody, Magnetism, Bispecific antibody, Elrexfio
Eligibility Criteria
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.
Sites / Locations
- Tom Baker Cancer Center
- Cross Cancer InstituteRecruiting
- McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elranatamab
Arm Description
Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Outcomes
Primary Outcome Measures
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
Incidence of serious adverse events (SAEs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06057402
Brief Title
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
Acronym
MagnetisMM15
Official Title
ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
February 22, 2031 (Anticipated)
Study Completion Date
February 22, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Elranatamab, Post Trial Access, Roll-over Study, Extension Study, MM-15, MagnetisMM15, BCMA, BCMA antibody, Magnetism, Bispecific antibody, Elrexfio
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elranatamab
Arm Type
Experimental
Arm Description
Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Intervention Type
Drug
Intervention Name(s)
Elranatamab
Other Intervention Name(s)
Elrexfio
Intervention Description
Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Primary Outcome Measure Information:
Title
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
Time Frame
A minimum of 90 days after the last dose of study drug
Title
Incidence of serious adverse events (SAEs)
Time Frame
A minimum of 90 days after the last dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1071015
Description
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Learn more about this trial
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
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