Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

Study Overview
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Brief Summary
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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
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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.

Official Title
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ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Elranatamab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elranatamab<br>Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells | Drug: Elranatamab<br>* Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells<br>* Other names: Elrexfio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MM-15, Multiple Myeloma, Elranatamab, Post Trial Access, Roll-over Study, Extension Study, MagnetisMM15, BCMA, BCMA antibody, Magnetism, Bispecific antibody, Elrexfio