RecruitingPhase 1NCT05675449

A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

Sponsor

Pfizer

Enrollment

90 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new combinations of cancer drugs for people with multiple myeloma — a blood cancer — that has come back or stopped responding to prior treatments. It involves a newer targeted drug called elranatamab, combined with other medications, across two different treatment arms. **You may be eligible if...** - You have been diagnosed with multiple myeloma - Your cancer has returned or stopped responding to treatment - You have received at least 1 to 3 prior treatment regimens (Part 1) or at least 3 prior lines including an IMiD, a proteasome inhibitor, and an anti-CD38 antibody (Part 2) - You are in fairly good physical health (ECOG performance status 0–1) - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have certain related blood conditions like plasma cell leukemia, Waldenström's disease, or POEMS syndrome - You have active, uncontrolled infections - You had a stem cell transplant within the past 12 weeks - You have significant heart disease - You received a live vaccine within 4 weeks of starting the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElranatamab

BCMA-CD3 bispecific antibody

DRUGCarfilzomib

proteasome inhibitor

DRUGMaplirpacept

CD47-SIRP alpha-directed

Locations(39)

Memorial Hospital for Cancer and Allied Diseases

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

State University of Iowa, Division of Sponsored Programs

Iowa City, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

Clinical Research Advisors (Encino Satellite Location)

Encino, California, United States

Oncology Investigational Drug Service,Department of Pharmacy Services

Baltimore, Maryland, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida, United States

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Coral Gables, Florida, United States

Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida, United States

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, United States

Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida, United States

Johns Hopkins University Cancer Immunology/GI Oncology

Baltimore, Maryland, United States

Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Clinical Research Advisors (Korea Town Satellite Location)

Los Angeles, California, United States

Clinical Research Advisors (West Hollywood Satellite Location)

Los Angeles, California, United States

MSK Monmouth

Middletown, New Jersey, United States

Rambam Health Care Campus

Haifa, Israel

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

New York, New York, United States

Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

Rabin Medical Center

Petah Tikva, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

Dana Farber/Mass General Brigham Cancer Care, Inc

Boston, Massachusetts, United States

Division of Hematology Hadassah Medical Center - Ein Kerem

Jerusalem, Israel

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Administration Office

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Griffin Cancer Research Building (GCRB)

Miami, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

University of Miami Hospital and Clinics

Miami, Florida, United States

Sylvester Comprehensive Cancer Center - Kendall

Miami, Florida, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The Research Fund of Hadassah Medical Organization (R.A.)

Jerusalem, Israel

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NCT05675449

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