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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

Banner Gateway Medical Center
Gilbert, Arizona 85234

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234

University of Arkansas for Medical Sciences - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas 72205

Beverly Hills Cancer Center
Beverly Hills, California 90211

Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD
Los Angeles, California 90048

Cedars Sinai Medical Center
Los Angeles, California 90048

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)
Los Angeles, California 90048

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida 33146

Sylvester Comprehensive Cancer Center- Deerfield Beach
Deerfield Beach, Florida 33442

Sylvester Comprehensive Cancer Center
Miami, Florida 33136

UHealth Tower
Miami, Florida 33136

UChicago Medicine - River East
Chicago, Illinois 60611

University of Chicago Medical Center
Chicago, Illinois 60637

UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois 60422

UChicago Medicine Ingalls Memorial
Harvey, Illinois 60426

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois 60451

The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois 60462

UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois 60477

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242

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

The University of Kansas Clinical Research Center
Fairway, Kansas 66205

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

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 Cancer Center - Indian Creek Campus
Overland Park, Kansas 66211

The University of Kansas Cancer Center
Westwood, Kansas 66205

OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility)
Baltimore, Maryland 21231

Massachusetts General Hospital
Boston, Massachusetts 02114

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02115

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Nebraska Medicine - Bellevue Medical Center
Bellevue, Nebraska 68123

Nebraska Medicine - Nebraska Medical Center
Omaha, Nebraska 68105

Nebraska Medicine - Cancer Center at Village Pointe Health Center
Omaha, Nebraska 68118

University Of Nebraska Medical Center
Omaha, Nebraska 68198

More Details

NCT ID
NCT05090566
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.