The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active enrolling
United States, Argentina, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Spain, Sweden, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Elranatamab
Participants will receive elranatamab monotherapy
DRUG: Elranatamab
Elranatamab will be administered subcutaneouslyACTIVE_COMPARATOR: Investigator's Choice
Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
DRUG: Elotuzumab
Elotuzumab will be administered intravenouslyDRUG: Pomalidomide
Pomalidomide will be administered orallyDRUG: Dexamethasone
Dexamethasone will be administered orallyDRUG: Bortezomib
Bortezomib will be administered subcutaneously or intravenouslyDRUG: Carfilzomib
Carfilzomib will be administered intravenouslyProgression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Up to approximately 5 years
Overall survival
From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first
Up to approximately 5 years
Progression free survival on next-line treatment per International Myeloma Working Group criteria
From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first
Up to approximately 5 years
Objective response rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy
Up to approximately 5 years
Duration of response per International Myeloma Working Group criteria
From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Up to approximately 5 years
Very good partial response or better response rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Up to approximately 5 years
Complete response rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Up to approximately 5 years
Duration of complete response per International Myeloma Working Group criteria
From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Up to approximately 5 years
Time to response per International Myeloma Working Group criteria
From date of randomization to date of confirmed objective response
Up to approximately 5 years
Minimal residual disease negativity rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Up to approximately 5 years
Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Up to approximately 5 years
Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria
From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first
Up to approximately 5 years
Frequency of treatment-emergent adverse events
From date of first dose of study intervention up to 90 days after last study intervention administration
Frequency of abnormal laboratory results
From date of first dose of study intervention up to 90 days after last study intervention administration
Free elranatamab serum trough concentration [Ctrough]
From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Elranatamab immunogenicity by anti-drug antibodies against elranatamab
From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Change from baseline scores
From date of informed consent up to approximately 35 days after last administration of study intervention
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Change from baseline scores
From date of informed consent up to approximately 35 days after last administration of study intervention
492
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT06152575
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