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
Australia, Canada, Czechia, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Taiwan
for more information at clinicaltrials.gov
EXPERIMENTAL: Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
DRUG: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
EXPERIMENTAL: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
DRUG: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
EXPERIMENTAL: Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
DRUG: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
ACTIVE_COMPARATOR: Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone
DRUG: Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Dexamethasone
Randomized
EXPERIMENTAL: Part 1: Elranatamab + Lenalidomide
DRUG: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
EXPERIMENTAL: Part 2: Randomized Arm A: Elranatamab + Lenalidomide
DRUG: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
DRUG: Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Part 1 Dose Limiting Toxicity
From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
Part 2: Progression free survival by blinded independent central review
From randomization up to 79 months.
Part 2: Minimal Residual Disease negativity rate
At 12 months after randomization
Overall Survival
From date of randomization up to 79 months
Overall minimal residual disease negativity rate
From date of randomization up to 79 months
Sustained MRD negativity rate (Part 2)
From date of randomization up to 79 months
Duration of minimal residual disease negativity (Part 2)
From date of minimal residual disease negative status up to 79 months
PFS by investigator
From date of randomization up to 79 months
PFS2 by investigator (Part 2)
From the date of randomization up to 79 months
Objective Response Rate
From the date of randomization up to 79 months
Complete Response Rate
From the date of randomization up to 79 months
Time to Response
From the date of randomization to date of confirmed objective response up to 79 months
Duration of Response
From the date of confirmed objective response up to 79 months
Duration of Complete Response
From the date of confirmed complete response up to 79 months
Frequency of treatment-emergent adverse events
From the date of first dose of study intervention up to 79 months
Frequency of abnormal laboratory results
From the date of first dose of study intervention up to 79 months
Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations
Predose and post dose concentrations of elranatamab
From date of first dose of study intervention up to 79 months
Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Immunogenicity of elranatamab
From date of first dose of study intervention up to 79 months
Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)
Predose concentrations of daratumumab and lenalidomide
From date of first dose of study intervention up to 79 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)
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 the symptom scales/items represent a greater presence of symptoms.
From date the informed consent is signed up to 79 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Myeloma 20 (Part 2)
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
From date the informed consent is signed up to 79 months
966
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.
NCT05623020
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