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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Pfizer
Study ID
NCT05675449
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    BCMA-CD3 bispecific antibody
  • Carfilzomib — DRUG
    proteasome inhibitor
  • Maplirpacept — DRUG
    CD47-SIRP alpha-directed

Study Details

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.

Key Dates

Start date
Dec 14, 2022
Status verified
Apr 2026
Primary completion
Jul 7, 2025
Completion
Feb 29, 2028

Study Design

Enrollment
59 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation
    Non randomized Elranatamab plus Carfilzomib and Dexamethasone
  • Experimental: Part 2A Dose Escalation
    Non randomized Elranatamab plus Maplirpacept
  • Experimental: Part 2B Dose Randomization
    Randomized dose level Elranatamab plus Maplirpacept

Primary Outcome Measure

Part 1 Number of participants with dose limiting toxicity (DLT) [ Time Frame: From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days. ]

Locations (31)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Clinical Research Advisors (Encino Satellite Location)EncinoCalifornia91316-
Clinical Research Advisors (Korea Town Satellite Location)Los AngelesCalifornia90020-
Clinical Research Advisors (West Hollywood Satellite Location)Los AngelesCalifornia90048-
Sylvester Comprehensive Cancer Center - AventuraAventuraFlorida33180-
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical CenterCoral GablesFlorida33146-
Sylvester Comprehensive Cancer Center - Coral SpringsCoral SpringsFlorida33065-
University of Miami Hospital and Clinics - Deerfield BeachDeerfield BeachFlorida33442-
Sylvester Comprehensive Cancer Center - HollywoodHollywoodFlorida33021-
Griffin Cancer Research Building (GCRB)MiamiFlorida33136-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Sylvester Comprehensive Cancer Center - KendallMiamiFlorida33176-
University of Miami Hospital and ClinicsMiamiFlorida33136-
Sylvester Comprehensive Cancer Center - PlantationPlantationFlorida33324-
Emory University Administration OfficeAtlantaGeorgia30322-
Emory University HospitalAtlantaGeorgia30322-
Emory University Hospital MidtownAtlantaGeorgia30308-
Winship Cancer InstituteAtlantaGeorgia30322-
State University of Iowa, Division of Sponsored ProgramsIowa CityIowa52242-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Johns Hopkins University Cancer Immunology/GI OncologyBaltimoreMaryland21287-
Oncology Investigational Drug Service,Department of Pharmacy ServicesBaltimoreMaryland21231-
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-
Dana Farber/Mass General Brigham Cancer Care, IncBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
MSK MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New YorkNew York10021-
Memorial Sloan Kettering Cancer Center - Main CampusNew YorkNew York10065-
Henry-Joyce Cancer ClinicNashvilleTennessee37232-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Little Rock, AR

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Arkansas for Medical Sciences· Little Rock, ARBeverly Hills Cancer Center· Beverly Hills, CAClinical Research Advisors (Encino Satellite Location)· Encino, CAClinical Research Advisors (Korea Town Satellite Location)· Los Angeles, CAClinical Research Advisors (West Hollywood Satellite Location)· Los Angeles, CASylvester Comprehensive Cancer Center - Aventura· Aventura, FL

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