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NCT06215118PHASE1Recruiting

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Pfizer

Start Date

2/20/2024

Completion Date

3/9/2028

Summary

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Prior diagnosis of multiple myeloma as defined by IMWG criteria * Measurable disease based on IMWG criteria as defined by at least 1 of the following: * Serum M-protein ≥0.5 g/dL by SPEP * Urinary M-protein excretion ≥200 mg/24 hour by UPEP * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65) * Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor. * Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor. * ECOG performance status 0-1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 Exclusion Criteria: * Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome * Impaired cardiovascular function or clinically significant cardiovascular diseases * Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease * Participants with any active, uncontrolled bacterial, fungal, or viral infection * Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Previous treatment with: * BCMA-directed or CD3 redirecting therapy * Iberdomide (CC-220) or Mezigdomide * Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study * Administration with an investigational product within 30 days preceding the first dose of study intervention * Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

Interventions

DRUG

Elranatamab

DRUG

Iberdomide

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Conditions

Multiple Myeloma

Locations

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida 33146

United States

University of Miami Hospital and Clinics Deerfield Beach

Deerfield Beach, Florida 33442

United States

Sylvester Comprehensive Cancer Center- Doral

Doral, Florida 33166

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

University of Miami Hospital and Clinics

Miami, Florida 33136

United States

Sylvester Comprehensive Cancer Center Kendall

Miami, Florida 33176

United States

Sylvester Comprehensive Cancer Center Plantation

Plantation, Florida 33324

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Winship Cancer Institute

Atlanta, Georgia 30322

United States

Indiana CTSI Clinical Research Center (ICRC)

Indianapolis, Indiana 46202

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)

Indianapolis, Indiana 46202

United States

University of Maryland

Baltimore, Maryland 21201

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts 02459

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

Methodist Hospital

Omaha, Nebraska 68114

United States

Oncology Hematology West P.C. dba Nebraska Cancer - Methodist

Omaha, Nebraska 68114

United States

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

MSK Basking Ridge

Basking Ridge, New Jersey 07920

United States

MSK Monmouth

Middletown, New Jersey 07748

United States

MSK Bergen

Montvale, New Jersey 07645

United States

MSK Commack

Commack, New York 11725

United States

MSK Westchester

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York 11101

United States

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York 10021

United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York 10065

United States

MSK Nassau

Uniondale, New York 11553

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Washington

Seattle, Washington 98195

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

Calvary Mater Newcastle

Waratah, New South Wales 2298

Australia

Townsville University Hospital

Douglas, Queensland 4814

Australia

Epworth Freemasons

East Melbourne, Victoria 3002

Australia

Epworth Hospital

Richmond, Victoria 3121

Australia

Slade Pharmacy

Richmond, Victoria 3121

Australia

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick E3B 5N5

Canada

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec H1T 2M4

Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer

Sherbrooke, Quebec J1H 5N4

Canada