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

Last updated: April 9, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Multiple Myeloma

Bone Neoplasm

Treatment

Carfilzomib

Maplirpacept

Elranatamab

Clinical Study ID

NCT05675449
C1071020
MAGNETISMM-20
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 serumimmunoglobulin 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 multiplemyeloma (induction therapy followed by stem cell transplant andconsolidation/maintenance therapy will be considered as 1 line of therapy).

  • Part 2: Received at least 3 prior lines of therapy for multiple myeloma who arerefractory 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

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 versushost disease.

  • Any other active malignancy within 3 years prior to enrollment, except foradequately 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 exceptionof 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) concurrentwith study intervention or within 30 days preceding the first dose of studyintervention used in this study.

  • Any of the following within 3 months of enrollment: erosive esophagitis, treatmentresistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolismor uncontrolled thromboembolic event.

  • Intolerance to or participants who have had a severe (Grade ≥3) allergic oranaphylactic reaction to antibodies or therapeutic proteins

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Carfilzomib
Phase: 1
Study Start date:
December 14, 2022
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Division of Hematology Hadassah Medical Center - Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah Medical Center - Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hematology Division Davidoff Center, Rabin Medical Center, Bellinson Hospital

    Petach Tikvah, 4941494
    Israel

    Site Not Available

  • Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Ramat-Gan, 5265601
    Israel

    Active - Recruiting

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Beverly Hills Cancer Center

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Clinical Research Advisors (Encino Satellite Location)

    Encino, California 91316
    United States

    Active - Recruiting

  • Clinical Research Advisors (Korea Town Satellite Location)

    Los Angeles, California 90020
    United States

    Active - Recruiting

  • Clinical Research Advisors (West Hollywood Satellite Location)

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center - Aventura

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center - Coral Springs

    Coral Springs, Florida 33065
    United States

    Active - Recruiting

  • University of Miami Hospital and Clinics - Deerfield Beach

    Deerfield Beach, Florida 33442
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center - Hollywood

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center - Kendall

    Miami, Florida 33176
    United States

    Active - Recruiting

  • University of Miami Hospital And Clinics

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center - Plantation

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory University School of Medicine Investigational Drug Service

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Johns Hopkins Medicine

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Oncology Investigational Drug Service,Department of Pharmacy Services

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • MSK Monmouth

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

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

    New York, New York 10021
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York 10065
    United States

    Active - Recruiting

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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