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Protocol # 22-166

Status

Recruiting

Description

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Condition

  • Multiple Myeloma

Interventions

  • Elranatamab + Nirogacestat
  • Elranatamab + lenalidomide + dexamethasone

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Sub-Study A Phase 1: Dose Limiting Toxicity
  • Sub-Study A Phase 2: Objective Response Rate
  • Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity
  • Sub-Study B Phase 1 Expansion: Frequency of Treatment-Emergent Adverse Events
  • Sub-Study B Phase 1 Expansion: Frequency of Laboratory Abnormalities

Secondary Outcome:

  • Sub-Study A Phase 1: Objective Response Rate
  • Sub-Study A Phase 1 and Phase 2: Complete Response Rate
  • Sub-Study A Phase 1 and Phase 2: Time to Response
  • Sub-Study A Phase 1 and 2: Duration of Response
  • Sub-Study A Phase 1 and Phase 2: Duration of Complete Response
  • Sub-Study A Phase 1 and Phase 2: Progression Free Survival
  • Sub-Study A Phase 1 and Phase 2: Overall Survival
  • Sub-Study A Phase 1 and Phase 2: Minimal Residual Disease Negativity Rate
  • Sub-Study A Phase 1 and Phase 2: Frequency of Treatment-Emergent Adverse Events
  • Sub-Study A Phase 1 and Phase 2: Frequency of Laboratory Abnormalities
  • Sub-Study A Phase 1 and Phase 2: Immunogenicity of elranatamab in combination with nirogacestat
  • Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat
  • Sub-Study A Phase 1: Maximum Observed Concentration (Cmax) for elranatamab
  • Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab
  • Sub-Study A Phase 1: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab
  • Sub-Study B Phase 1 Escalation: Frequency of Treatment-Emergent Adverse Events
  • Sub-Study B Phase 1 Escalation: Frequency of Laboratory Abnormalities
  • Sub-Study B Phase 1 Escalation and Expansion: Objective Response Rate
  • Sub-Study B Phase 1 Escalation and Expansion: Complete Response Rate
  • Sub-Study B Phase 1 Escalation and Expansion: Time to Response
  • Sub-Study B Phase 1 Escalation and Expansion: Duration of Response
  • Sub-Study B Phase 1 Escalation and Expansion: Duration of Complete Response
  • Sub-Study B Phase 1 Escalation and Expansion: Progression Free Survival
  • Sub-Study B Phase 1 Escalation and Expansion: Overall Survival
  • Sub-Study B Phase 1 Escalation and Expansion: Minimal Residual Disease Negativity Rate
  • Sub-Study B Phase 1 Escalation and Expansion: Immunogenicity of elranatamab in combination with lenalidomide
  • Sub-Study B Phase 1 Escalation and Expansion: Concentrations of elranatamab and/or lenalidomide
  • Sub-Study B Phase 1 Escalation and Expansion: Maximum Observed Concentrations (Cmax) for elranatamab
  • Sub-Study B Phase 1 Escalation and Expansion: Time to Maximum Concentration (Tmax) for elranatamab
  • Sub-Study B Phase 1 Escalation and Expansion: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab

Enrollment

105

Study Start Date

October 27, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Pfizer

Source

Pfizer

Official title

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

Clinicaltrials.gov Identifier

NCT05090566

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.