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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, Canada
for more information at clinicaltrials.gov
EXPERIMENTAL: Part 1 Dose Escalation
Non-randomized elranatamab plus iberdomide
DRUG: Elranatamab
BCMA-CD3 bispecific antibodyDRUG: Iberdomide
cereblon-modulating agentEXPERIMENTAL: Part 2 Dose Randomization
Randomized elranatamab plus iberdomide
DRUG: Elranatamab
BCMA-CD3 bispecific antibodyDRUG: Iberdomide
cereblon-modulating agentPart 1: Number of participants with dose limiting toxicity (DLT)
Dose limiting toxicity rate based on dose limiting toxicity evaluable participants
Cycle 1, about 28 days
Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.
Assessed from baseline up to 90 days after last dose of study treatment
Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.
Assessed from baseline up to 90 days after last dose of study treatment
Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibly of causal relationship
Assessed from baseline up to 90 days after last dose of study treatment
Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities
Laboratory abnormalities as characterized by type, frequency, severity
Assessed from baseline up to 90 days after last dose of study treatment
Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)
Percent of participants having confirmed Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) per IMWG criteria as determined by investigator
Assessed for approximately 2 years
Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)
Percent of participants having Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria as determined by investigator
Assessed for approximately 2 years
Part 1 and Part 2: Time to Response (TTR)
For participants with an objective response per IMWG criteria, TTR is the time from first dose to the first documentation of objective response that is subsequently confirmed
Assessed for approximately 2 years
Part 1 and Part 2: Duration of Response (DOR)
For participants with an objective response per IMWG criteria, DOR is the time from first documentation of objective response that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria
Assessed for approximately 2 years
Part 1 and Part 2: Duration of Complete Response (DOCR)
For participants with a Complete Response/ Stringent Complete Response (CR+sCR) per IMWG criteria, DOCR is the time from the first documentation of CR/sCR that is subsequently confirmed until the first documentation of confirmed progressive disease (PD) per IMWG criteria
Assessed for approximately 2 years
Part 1 and Part 2: Time of Progression Free Survival (PFS)
Progression free survival (IMWG criteria)
Assessed for approximately 2 years
Part 1 and Part 2: Time of Overall Survival (OS)
The duration of time from first dose of study treatment to death
Assessed for approximately 2 years
Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate
The proportion of participants achieving CR+sCR with negative MRD per IMWG sequencing criteria, from the date of first dose until the first documentation of confirmed progressive disease (PD), death, or start of new anticancer therapy.
Assessed for approximately 2 years
Part 1 and Part 2: Concentrations of elranatamab
Pre-dose and post-dose concentrations of elranatamab
Assessed for approximately 2 years
Part 1 and Part 2: Concentrations of iberdomide
Pre-dose concentrations of iberdomide
Assessed for approximately 4 months
Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
Percent of participants with positive ADA to elranatamab when given in combination with iberdomide
Assessed for approximately 2 years
87
Sponsor: Pfizer
Collaborator: Bristol-Myers Squibb
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: