Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Elranatamab
DrugElranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: ElranatamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
Time frame
A minimum of 90 days after the last dose of study drug2
Incidence of serious adverse events (SAEs)
Time frame
A minimum of 90 days after the last dose of study drug Source ClinicalTrials.gov