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.

Clinical Trial Details

Geo Regions

Category

Hematological Malignancies

Elranatamab

A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA
Phase 2
NCT05090566

Active enrolling

Globe
Locations

United States, Canada

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Study design

Participant Group/Arm

EXPERIMENTAL: Sub-Study A

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Intervention/Treatment

DRUG: Elranatamab + Nirogacestat

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Participant Group/Arm

EXPERIMENTAL: Sub-Study B

BCMA-CD3 bispecific antibody + immunomodulatory drug

Intervention/Treatment

DRUG: Elranatamab + lenalidomide + dexamethasone

BCMA-CD3 bispecific antibody + immunomodulatory

Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria
  • Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
  • Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
  • Measurable disease defined by at least one of the following:
    • Serum M-protein >/= 0.5 g/dL by SPEP
    • Urinary M-protein excretion >/= 200 mg/24 hours by UPEP
    • Serum immunoglobulin FLC >/= 10 mg/dL (>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
  • ECOG performance status 0 -1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade </= 1
Exclusion criteria
  • Active plasma cell leukemia
  • Amyloidosis
  • Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
  • POEMS syndrome
  • Any active uncontrolled bacterial, fungal, or viral infection
  • Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
  • Sub-Study A Only: Previous treatment with BCMA bispecific antibody
  • Sub-Study B Only: Previous treatment with BCMA directed therapy

Key dates

Study start date
  • October 2021
Estimated primary completion date
  • August 2025

Key endpoints

Primary Outcome Measures
Outcome Measure

Sub-Study A Phase 1: Dose Limiting Toxicity

Measure Description

Number of participants with Dose Limiting Toxicity

Time Frame

approximately 35 days

Outcome Measure

Sub-Study A Phase 2: Objective Response Rate

Measure Description

Objective response rate (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity

Measure Description

Number of participants with Dose Limiting Toxicity

Time Frame

approximately 42 days

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Sub-Study A Phase 1: Objective Response Rate

Measure Description

Objective response rate (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Complete Response Rate

Measure Description

Complete response rate (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Time to Response

Measure Description

Time to response (IMWG criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study A Phase 1 and 2: Duration of Response

Measure Description

Duration of response (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Duration of Complete Response

Measure Description

Duration of complete response (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Progression Free Survival

Measure Description

Progression free survival (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Overall Survival

Measure Description

Overall survival

Time Frame

assessed for approximately 2 years

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Minimal Residual Disease Negativity Rate

Measure Description

Minimal residual disease negativity rate (IMWG response criteria)

Time Frame

assessed approximately every 12 months (for approximately 2 years)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Frequency of Treatment-Emergent Adverse Events

Measure Description

Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)

Time Frame

assessed for approximately 2 years

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Frequency of Laboratory Abnormalities

Measure Description

Type and severity per NCI CTCAE v5

Time Frame

assessed every cycle (each cycle approximately 28 days)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Immunogenicity of elranatamab in combination with nirogacestat

Measure Description

Anti-drug antibodies and neutralizing antibodies against elranatamab

Time Frame

assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)

Outcome Measure

Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat

Measure Description

Pre-dose and post-dose concentrations of elranatamab; pre-dose concentrations of nirogacestat

Time Frame

assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)

Outcome Measure

Sub-Study A Phase 1: Maximum Observed Concentration (Cmax) for elranatamab

Measure Description

Cmax for elranatamab administration

Time Frame

assessed after first elranatamab dose (approximately 3-7 days)

Outcome Measure

Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab

Measure Description

Tmax for elranatamab administration

Time Frame

assessed after first elranatamab dose (approximately 3-7 days)

Outcome Measure

Sub-Study A Phase 1: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab

Measure Description

AUClast for elranatamab administration

Time Frame

assessed after first elranatamab dose (approximately 3-7 days)

Outcome Measure

Sub-Study B Phase 1 Escalation: Frequency of Treatment-Emergent Adverse Events

Measure Description

Type and severity per NCI CTCAE v5 (CRS and ICANS assessed per ASTCT criteria)

Time Frame

assessed for approximately 2 years

Outcome Measure

Sub-Study B Phase 1 Escalation: Frequency of Laboratory Abnormalities

Measure Description

Type and severity per NCI CTCAE v5

Time Frame

assessed every cycle (each cycle approximately 28 days)

Outcome Measure

Sub-Study B Phase 1 Escalation: Objective Response Rate

Measure Description

Objective response rate (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Complete Response Rate

Measure Description

Complete response rate (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Time to Response

Measure Description

Time to response (IMWG criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Duration of Response

Measure Description

Duration of response (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Duration of Complete Response

Measure Description

Duration of complete response (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Progression Free Survival

Measure Description

Progression free survival (IMWG response criteria)

Time Frame

assessed every 4 weeks (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Overall Survival

Measure Description

Overall survival

Time Frame

assessed for approximately 2 years

Outcome Measure

Sub-Study B Phase 1 Escalation: Minimal Residual Disease Negativity Rate

Measure Description

Minimal residual disease negativity ratio (IMWG response criteria)

Time Frame

assessed approximately every 12 months (for approximately 2 years)

Outcome Measure

Sub-Study B Phase 1 Escalation: Immunogenicity of elranatamab in combination with lenalidomide

Measure Description

Anti-drug antibodies and neutralizing antibodies against elranatamab

Time Frame

assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)

Outcome Measure

Sub-Study B Phase 1 Escalation: Concentrations of elranatamab and/or lenalidomide

Measure Description

Pre-dose and post-dose concentrations of elranatamab, pre-dose concentrations of lenalidomide

Time Frame

assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)

Outcome Measure

Sub-Study B Phase 1 Escalation: Maximum Observed Concentrations (Cmax) for elranatamab

Measure Description

Cmax for elranatamab administration

Time Frame

assessed after first elranatamab dose (approximately 3-7 days)

Outcome Measure

Sub-Study B Phase 1 Escalation: Time to Maximum Concentration (Tmax) for elranatamab

Measure Description

Tmax for elranatamab administration

Time Frame

assessed after first elranatamab dose (approximately 3-7 days)

Outcome Measure

Sub-Study B Phase 1 Escalation: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab

Measure Description

AUClast for elranatamab administration

Time Frame

assessed after first elranatamab dose (approximately 3-7 days)

Secondary Outcome Measures table for Clinical Trial

Number of participants

120

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of April 12th 2024.
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More Information Close 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