Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Pfizer
Study ID
NCT05317416
Phase
PHASE3
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
  • Lenalidomide — DRUG
    Immunomodulatory drug
  • Lenalidomide — DRUG
    Immunomodulatory drug
  • Elranatamab — DRUG
    BCMA-CD3 bispecific antibody

Study Details

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Key Dates

Start date
Mar 25, 2022
Status verified
Apr 2026
Primary completion
Aug 4, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
854 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Part 1
    Elranatamab
  • Active Comparator: Arm B - Part 1
    Lenalidomide
  • Active Comparator: Arm B - Part 2
    Lenalidomide
  • Experimental: Arm C - Part 2
    Elranatamab

Primary Outcome Measure

Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ]

Locations (24)

FacilityCityStateZIPSite coordinators
Banner Gateway Medical CenterGilbertArizona85234-
Banner Gateway Medical PavilionGilbertArizona85234-
Banner MD Anderson Cancer CenterGilbertArizona85234-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
UCLA Department of Medicine - Hematology/OncologyLos AngelesCalifornia90095-
UCLA Hematology/OncologyLos AngelesCalifornia90095-
Santa Monica UCLA Medical Center & Orthopaedic HospitalSanta MonicaCalifornia90404-
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Loyola University ChicagoMaywoodIllinois60153-
Ascentist Doctor HospitalLeawoodKansas66211-
University of MichiganAnn ArborMichigan48109-
American Oncology Partners, P.A. Dba MidAmerica Cancer CareKansas CityMissouri64132-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
WMCHealth Advanced Physician ServicesHawthorneNew York10532-
Westchester Medical CenterValhallaNew York10595-
Cleveland ClinicClevelandOhio44195-
OhioHealth Arthur G.H. Bing, MD, Cancer CenterColumbusOhio43214-
OhioHealth Research InstituteColumbusOhio43214-
OhioHealth Riverside Methodist HospitalColumbusOhio43214-
Baylor University Medical CenterDallasTexas75246-
Baylor Scott & White Medical Center - TempleTempleTexas76508-

Find similar trials in Gilbert, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Banner Gateway Medical Center· Gilbert, AZBanner Gateway Medical Pavilion· Gilbert, AZBanner MD Anderson Cancer Center· Gilbert, AZRonald Reagan UCLA Medical Center· Los Angeles, CAUCLA Department of Medicine - Hematology/Oncology· Los Angeles, CAUCLA Hematology/Oncology· Los Angeles, CA

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