ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Pfizer
- Enrollment
- 80
- Locations
- 56
- Primary Endpoint
- Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Elranatamab
Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Intervention: Elranatamab (Drug)
Outcomes
Primary Outcomes
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
Time Frame: A minimum of 90 days after the last dose of study drug
Incidence of serious adverse events (SAEs)
Time Frame: A minimum of 90 days after the last dose of study drug
Secondary Outcomes
No secondary outcomes reported