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 Not-enrolling
United States, Japan, Taiwan, United Kingdom
EXPERIMENTAL: Part 1
Evaluation of step-up priming dosing
DRUG: Elranatamab
BCMA-CD3 bispecific antibody
EXPERIMENTAL: Part 2A
Dose determination
DRUG: Elranatamab
BCMA-CD3 bispecific antibody
EXPERIMENTAL: Part 2B
Dose expansion
DRUG: Elranatamab
BCMA-CD3 bispecific antibody
EXPERIMENTAL: Part 2C
To explore higher dose intensity
DRUG: Elranatamab
BCMA-CD3 bispecific antibody
1. Serum M-protein \>0.5 g/dL by SPEP 2. Urinary M-protein excretion \>200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio * Refractory to at least one IMiD * Refractory to at least one PI * Refractory to at least one anti-CD38 antibody * Relapsed/refractory to last anti-myeloma regimen * ECOG performance status ≤1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 * Not pregnant and willing to use contraception
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS) (Part 1 and 2)
Cytokine release syndrome severity assessed by American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Cycle 1 (28 days)
Incidence of Dose Limiting Toxicities (Part 2A and 2C)
28 days starting on the first dose of 116 or 152 mg
Frequency of Adverse Events
Adverse Events as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, timing, seriousness, and relationship to elranatamab
Up to 90 days after last dose and for approximately 2 years
Frequency of laboratory abnormalities
Assessed at every cycles [each cycle approximately 28 days]
Objective response rate
Objective response rate per International Myeloma Working Group (IMWG) response criteria
Assessed approximately every 28 days and for approximately 2 years
Complete Response Rate
Complete Response Rate per IMWG response criteria
Assessed approximately every 28 days and for approximately 2 years
Time to response
Time to response per IMWG response criteria
Assessed approximately every 28 days and for approximately 2 years
Duration of response
Duration of response per IMWG response criteria
Assessed approximately every 28 days and for approximately 2 years
Duration of complete response rate
Duration of complete response rate per IMWG response criteria
Assessed approximately every 28 days and for approximately 2 years
Progression Free Survival
Assessed approximately every 28 days for approximately 2 years
Overall Survival
Approximately 2 years
Minimal Residual Disease negativity rate
Minimal Residual Disease negativity rate assessed by central lab per IMWG sequencing criteria
Assessed approximately every 12 months and for approximately 2 years
Pre- and postdose concentrations of elranatamab
Pharmacokinetic of elranatamab
Assessed approximately every 1 to 4 cycles [cycle of approximately 28 days]
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Immunogenicity of elranatamab
Assessed approximately every 1 to 6 cycles [cycle of approximately 28 days]
86
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.
NCT05014412
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