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, Canada
for more information at clinicaltrials.gov
EXPERIMENTAL: Sub-Study A
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
DRUG: Elranatamab + Nirogacestat
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
EXPERIMENTAL: Sub-Study B
BCMA-CD3 bispecific antibody + immunomodulatory drug
DRUG: Elranatamab + lenalidomide + dexamethasone
BCMA-CD3 bispecific antibody + immunomodulatory
Sub-Study A Phase 1: Dose Limiting Toxicity
Number of participants with Dose Limiting Toxicity
approximately 35 days
Sub-Study A Phase 2: Objective Response Rate
Objective response rate (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity
Number of participants with Dose Limiting Toxicity
approximately 42 days
Sub-Study A Phase 1: Objective Response Rate
Objective response rate (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study A Phase 1 and Phase 2: Complete Response Rate
Complete response rate (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study A Phase 1 and Phase 2: Time to Response
Time to response (IMWG criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study A Phase 1 and 2: Duration of Response
Duration of response (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study A Phase 1 and Phase 2: Duration of Complete Response
Duration of complete response (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study A Phase 1 and Phase 2: Progression Free Survival
Progression free survival (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study A Phase 1 and Phase 2: Overall Survival
Overall survival
assessed for approximately 2 years
Sub-Study A Phase 1 and Phase 2: Minimal Residual Disease Negativity Rate
Minimal residual disease negativity rate (IMWG response criteria)
assessed approximately every 12 months (for approximately 2 years)
Sub-Study A Phase 1 and Phase 2: Frequency of Treatment-Emergent Adverse Events
Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)
assessed for approximately 2 years
Sub-Study A Phase 1 and Phase 2: Frequency of Laboratory Abnormalities
Type and severity per NCI CTCAE v5
assessed every cycle (each cycle approximately 28 days)
Sub-Study A Phase 1 and Phase 2: Immunogenicity of elranatamab in combination with nirogacestat
Anti-drug antibodies and neutralizing antibodies against elranatamab
assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat
Pre-dose and post-dose concentrations of elranatamab; pre-dose concentrations of nirogacestat
assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Sub-Study A Phase 1: Maximum Observed Concentration (Cmax) for elranatamab
Cmax for elranatamab administration
assessed after first elranatamab dose (approximately 3-7 days)
Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab
Tmax for elranatamab administration
assessed after first elranatamab dose (approximately 3-7 days)
Sub-Study A Phase 1: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab
AUClast for elranatamab administration
assessed after first elranatamab dose (approximately 3-7 days)
Sub-Study B Phase 1 Escalation: Frequency of Treatment-Emergent Adverse Events
Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)
assessed for approximately 2 years
Sub-Study B Phase 1 Escalation: Frequency of Laboratory Abnormalities
Type and severity per NCI CTCAE v5
assessed every cycle (each cycle approximately 28 days)
Sub-Study B Phase 1 Escalation: Objective Response Rate
Objective response rate (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Complete Response Rate
Complete response rate (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Time to Response
Time to response (IMWG criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Duration of Response
Duration of response (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Duration of Complete Response
Duration of complete response (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Progression Free Survival
Progression free survival (IMWG response criteria)
assessed every 4 weeks (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Overall Survival
Overall survival
assessed for approximately 2 years
Sub-Study B Phase 1 Escalation: Minimal Residual Disease Negativity Rate
Minimal residual disease negativity ratio (IMWG response criteria)
assessed approximately every 12 months (for approximately 2 years)
Sub-Study B Phase 1 Escalation: Immunogenicity of elranatamab in combination with lenalidomide
Anti-drug antibodies and neutralizing antibodies against elranatamab
assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Sub-Study B Phase 1 Escalation: Concentrations of elranatamab and/or lenalidomide
Pre-dose and post-dose concentrations of elranatamab, pre-dose concentrations of lenalidomide
assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Sub-Study B Phase 1 Escalation: Maximum Observed Concentrations (Cmax) for elranatamab
Cmax for elranatamab administration
assessed after first elranatamab dose (approximately 3-7 days)
Sub-Study B Phase 1 Escalation: Time to Maximum Concentration (Tmax) for elranatamab
Tmax for elranatamab administration
assessed after first elranatamab dose (approximately 3-7 days)
Sub-Study B Phase 1 Escalation: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab
AUClast for elranatamab administration
assessed after first elranatamab dose (approximately 3-7 days)
120
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.
NCT05090566
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