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, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Arm A - Part 1
Elranatamab
DRUG: Elranatamab
BCMA-CD3 bispecific antibodyACTIVE_COMPARATOR: Arm B - Part 1
Lenalidomide
DRUG: Lenalidomide
Immunomodulatory drugACTIVE_COMPARATOR: Arm B - Part 2
Lenalidomide
DRUG: Lenalidomide
Immunomodulatory drugEXPERIMENTAL: Arm C - Part 2
Elranatamab
DRUG: Elranatamab
BCMA-CD3 bispecific antibodyProgression Free Survival
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
Assessed for up to approximately 5 years
Overall Survival
Defined as the time from randomization until death due to any cause
Assessed for up to approximately 5 years
Minimal Residual Disease negativity rate
Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
12 months after randomization
Sustained MRD negativity rate
Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
24 months after randomization
Progression Free Survival
Progression Free Survival by investigator per IMWG response criteria
Assessed for up to approximately 5 years
Overall minimal residual disease negativity rate
Minimal residual disease negativity rate per IMWG criteria
Assessed for up to approximately 5 years
Duration of minimal residual disease negativity
Minimal residual disease negativity per IMWG criteria
Assessed for up to approximately 5 years
Sustained minimal residual disease negativity rate
Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months
Assessed for up to approximately 5 years
Complete response rate
Complete response rate by blinded independent central review and by investigator per IMWG criteria
Assessed for up to approximately 5 years
Duration of complete response
Duration of complete response by blinded independent central review and by investigator per IMWG criteria
Assessed for up to approximately 5 years
Frequency of adverse events
Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention
Up to 90 days after last dose
Frequency of laboratory abnormalities
Assessed for up to approximately 5 years
Pre-dose concentrations of elranatamab
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
Assessed for up to approximately 5 years
Post-dose concentrations of elranatamab
Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"
Assessed for up to approximately 5 years
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Immunogenicity of elranatamab
Assessed for up to approximately 5 years
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms
Assessed for up to approximately 5 years
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
Assessed for up to approximately 5 years
Progression Free Survival 2
Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria
Assessed for up to approximately 5 years
760
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.
NCT05317416
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