MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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: 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

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05090566
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Sub-Study A

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Experimental: Sub-Study B

BCMA-CD3 bispecific antibody + immunomodulatory drug

Interventions

Drug: - Elranatamab + Nirogacestat

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Drug: - Elranatamab + lenalidomide + dexamethasone

BCMA-CD3 bispecific antibody + immunomodulatory

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Banner Gateway Medical Center, Gilbert, Arizona

Status

Recruiting

Address

Banner Gateway Medical Center

Gilbert, Arizona, 85234

Banner MD Anderson Cancer Center, Gilbert, Arizona

Status

Recruiting

Address

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas for Medical Sciences - Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, 72205

Beverly Hills Cancer Center, Beverly Hills, California

Status

Recruiting

Address

Beverly Hills Cancer Center

Beverly Hills, California, 90211

Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD

Los Angeles, California, 90048

Cedars Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)

Los Angeles, California, 90048

Coral Gables, Florida

Status

Recruiting

Address

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, 33146

Deerfield Beach, Florida

Status

Recruiting

Address

Sylvester Comprehensive Cancer Center- Deerfield Beach

Deerfield Beach, Florida, 33442

Sylvester Comprehensive Cancer Center, Miami, Florida

Status

Recruiting

Address

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

UHealth Tower, Miami, Florida

Status

Recruiting

Address

UHealth Tower

Miami, Florida, 33136

UChicago Medicine - River East, Chicago, Illinois

Status

Recruiting

Address

UChicago Medicine - River East

Chicago, Illinois, 60611

University of Chicago Medical Center, Chicago, Illinois

Status

Recruiting

Address

University of Chicago Medical Center

Chicago, Illinois, 60637

UChicago Medicine at Ingalls - Flossmoor, Flossmoor, Illinois

Status

Recruiting

Address

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, 60422

UChicago Medicine Ingalls Memorial, Harvey, Illinois

Status

Recruiting

Address

UChicago Medicine Ingalls Memorial

Harvey, Illinois, 60426

New Lenox, Illinois

Status

Recruiting

Address

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, 60451

Orland Park, Illinois

Status

Recruiting

Address

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, 60462

Tinley Park, Illinois

Status

Recruiting

Address

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, 60477

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Fairway, Kansas

Status

Recruiting

Address

The University of Kansas Cancer Center ,Investigational Drug Services

Fairway, Kansas, 66205

Fairway, Kansas

Status

Recruiting

Address

The University of Kansas Clinical Research Center

Fairway, Kansas, 66205

Kansas City, Kansas

Status

Recruiting

Address

The University of Kansas Hospital Investigational Drug Services

Kansas City, Kansas, 66103

The University of Kansas Hospital, Kansas City, Kansas

Status

Recruiting

Address

The University of Kansas Hospital

Kansas City, Kansas, 66160

Kansas City, Kansas

Status

Recruiting

Address

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, 66160

Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, 66160

Overland Park, Kansas

Status

Recruiting

Address

The University of Kansas Cancer Center - Indian Creek Campus

Overland Park, Kansas, 66211

The University of Kansas Cancer Center, Westwood, Kansas

Status

Recruiting

Address

The University of Kansas Cancer Center

Westwood, Kansas, 66205

Baltimore, Maryland

Status

Recruiting

Address

OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231

Baltimore, Maryland

Status

Recruiting

Address

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility)

Baltimore, Maryland, 21231

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Not yet recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Not yet recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Bellevue, Nebraska

Status

Recruiting

Address

Nebraska Medicine - Bellevue Medical Center

Bellevue, Nebraska, 68123

Omaha, Nebraska

Status

Recruiting

Address

Nebraska Medicine - Nebraska Medical Center

Omaha, Nebraska, 68105

Omaha, Nebraska

Status

Recruiting

Address

Nebraska Medicine - Cancer Center at Village Pointe Health Center

Omaha, Nebraska, 68118

University Of Nebraska Medical Center, Omaha, Nebraska

Status

Not yet recruiting

Address

University Of Nebraska Medical Center

Omaha, Nebraska, 68198

University Of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University Of Nebraska Medical Center

Omaha, Nebraska, 68198

International Sites

Tom Baker Cancer Center, Calgary, Alberta, Canada

Status

Recruiting

Address

Tom Baker Cancer Center

Calgary, Alberta, T2N4N2

The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada

Status

Recruiting

Address

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9