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ACTIVE NOT RECRUITING

NCT05675449

PHASE1

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-12-14

Completion Date

2028-02-29

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

DRUG

Elranatamab

BCMA-CD3 bispecific antibody

DRUG

Carfilzomib

proteasome inhibitor

DRUG

Maplirpacept

CD47-SIRP alpha-directed

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. * Urinary M-protein excretion ≥200 mg/24 hours. * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65). * Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy). * Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody. * ECOG performance status 0-1. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. * Not pregnant or breastfeeding and willing to use contraception. Exclusion Criteria: * Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM * Impaired cardiovascular function or clinically significant cardiovascular diseases. * Participants with any active, uncontrolled bacterial, fungal, or viral infection. * Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease. * 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. * Part 1: Previous treatment with a BCMA-directed therapy. * Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-directed therapy. * Part 1: Prior treatment with carfilzomib * Live attenuated vaccine within 4 weeks of the first dose of study intervention. * Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study. * Any of the following within 3 months of enrollment: erosive esophagitis, treatment resistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolism or uncontrolled thromboembolic event. * Intolerance to or participants who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or therapeutic proteins

Locations (36)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

Clinical Research Advisors (Encino Satellite Location)

Encino, California, 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

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

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

Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida, United States

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

State University of Iowa, Division of Sponsored Programs

Iowa City, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 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

Johns Hopkins University Cancer Immunology/GI Oncology

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber/Mass General Brigham Cancer Care, Inc

Boston, Massachusetts, United States

MSK Monmouth

Middletown, New Jersey, United States

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

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Rambam Health Care Campus

Haifa, Israel

Division of Hematology Hadassah Medical Center - Ein Kerem

Jerusalem, Israel

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

Jerusalem, Israel

Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

Rabin Medical Center

Petah Tikva, Israel

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (36)