Print

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: 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 - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sub-Study A 		BCMA-CD3 bispecific antibody + gamma secretase inhibitor
  • Drug: Elranatamab + Nirogacestat
    BCMA-CD3 bispecific antibody + gamma secretase inhibitor
    Other names:
    • PF-06863135, Ogsiveo
Experimental
Sub-Study B 		BCMA-CD3 bispecific antibody + immunomodulatory drug
  • Drug: Elranatamab + lenalidomide + dexamethasone
    BCMA-CD3 bispecific antibody + immunomodulatory
    Other names:
    • PF-06863135; Revlimid

Recruiting Locations

The University of Kansas Cancer Center ,Investigational Drug Services
Fairway, Kansas 66205

The University of Kansas Cancer Center
Westwood, Kansas 66205

The University of Kansas Clinical Research Center
Fairway, Kansas 66205

The University of Kansas Hospital
Kansas City, Kansas 66160

The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas 66160

University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas 66160

The University of Kansas Hospital Investigational Drug Services
Kansas City, Kansas 66103

The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas 66211

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.