A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma
NCT ID: NCT05675449
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2022-12-14
2028-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1 Dose Escalation
Non randomized Elranatamab plus Carfilzomib and Dexamethasone
Elranatamab
BCMA-CD3 bispecific antibody
Carfilzomib
proteasome inhibitor
Part 2A Dose Escalation
Non randomized Elranatamab plus Maplirpacept
Elranatamab
BCMA-CD3 bispecific antibody
Maplirpacept
CD47-SIRP alpha-directed
Part 2B Dose Randomization
Randomized dose level Elranatamab plus Maplirpacept
Elranatamab
BCMA-CD3 bispecific antibody
Maplirpacept
CD47-SIRP alpha-directed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Elranatamab
BCMA-CD3 bispecific antibody
Carfilzomib
proteasome inhibitor
Maplirpacept
CD47-SIRP alpha-directed
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
University Of Miami
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
University of Miami
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 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
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Rabin Medical Center
Petah Tikva, Central District, Israel
Rambam Health Care Campus
Haifa, , Israel
Division of Hematology Hadassah Medical Center - Ein Kerem
Jerusalem, , Israel
Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MAGNETISMM-20
Identifier Type: OTHER
Identifier Source: secondary_id
C1071020
Identifier Type: -
Identifier Source: org_study_id