Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
- Registration Number
- NCT06057402
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Elranatamab Elranatamab Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Arthur J.E. Child Comprehensive Cancer Centre
🇨🇦Calgary, Alberta, Canada
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada