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NCT05090566 | RECRUITING | Multiple Myeloma

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

Pfizer

Brief Summary:

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 or disease

Multiple Myeloma

Intervention/treatment

Elranatamab + Nirogacestat

Elranatamab + lenalidomide + dexamethasone

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2021-10-27
Estimated Primary Completion Date : 2026-01-31
Estimated Study Completion Date : 2027-10-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

Location Details

NCT05090566

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Banner Gateway Medical Center

Gilbert, Arizona, United States, 85234

RECRUITING

United States, Arizona

Banner Gateway Medical Pavilion

Gilbert, Arizona, United States, 85234

RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

RECRUITING

United States, Arkansa

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

Little Rock, Arkansa, United States, 72205

RECRUITING

United States, California

Beverly Hills Cancer Center

Beverly Hills, California, United States, 90211

RECRUITING

United States, California

Clinical Research Advisors

Encino, California, United States, 91316

RECRUITING

United States, California

Clinical Research Advisors

Los Angeles, California, United States, 90020

RECRUITING

United States, California

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

Los Angeles, California, United States, 90048

RECRUITING

United States, California

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

RECRUITING

United States, California

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

Los Angeles, California, United States, 90048

RECRUITING

United States, California

Clinical Research Advisors

Los Angeles, California, United States, 90048

RECRUITING

United States, Florida

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, United States, 33146

RECRUITING

United States, Florida

Sylvester Comprehensive Cancer Center- Deerfield Beach

Deerfield Beach, Florida, United States, 33442

RECRUITING

United States, Florida

Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Florida

UHealth Tower

Miami, Florida, United States, 33136

RECRUITING

United States, Illinois

UChicago Medicine - River East

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

RECRUITING

United States, Illinois

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, United States, 60422

RECRUITING

United States, Illinois

UChicago Medicine Ingalls Memorial

Harvey, Illinois, United States, 60426

RECRUITING

United States, Illinois

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States, 60451

RECRUITING

United States, Illinois

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, United States, 60462

RECRUITING

United States, Illinois

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, United States, 60477

RECRUITING

United States, Maryland

OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21231

RECRUITING

United States, Maryland

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

Baltimore, Maryland, United States, 21231

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

RECRUITING

Canada, Alberta

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

RECRUITING

Canada, Ontario

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada, K1h 8l6

RECRUITING

Canada, Ontario

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9