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 inhibitorEXPERIMENTAL: Sub-Study B
BCMA-CD3 bispecific antibody + immunomodulatory drug
DRUG: Elranatamab + lenalidomide + dexamethasone
BCMA-CD3 bispecific antibody + immunomodulatorySub-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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