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Набира участници Фаза 1 NCT06215118

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Multiple Myeloma

Спонсор: Pfizer

Налично на: БГ
Обобщение
The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.
Кой може да участва
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 by SPEP * Urinary M-protein excretion ≥200 mg/24 hour by UPEP * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65) * Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor. * Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor. * ECOG performance status 0-1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 Exclusion Criteria: * Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome * Impaired cardiovascular function or clinically significant cardiovascular diseases * Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease * Participants with any active, uncontrolled bacterial, fungal, or viral infection * 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 * Previous treatment with: * BCMA-directed or CD3 redirecting therapy * Iberdomide (CC-220) or Mezigdomide * Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study * Administration with an investigational product within 30 days preceding the first dose of study intervention * Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis
Интервенции
Elranatamab
DRUG
Iberdomide
DRUG
Места на провеждане 43
Австралия (6)
Townsville University Hospital
Douglas , Queensland
Epworth Freemasons
East Melbourne , Victoria
Liverpool Hospital
Liverpool , New South Wales
Epworth Hospital
Richmond , Victoria
Slade Pharmacy
Richmond , Victoria
Calvary Mater Newcastle
Waratah , New South Wales
Канада (3)
Dr. Everett Chalmers Regional Hospital
Fredericton , New Brunswick
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal , Quebec
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
Sherbrooke , Quebec
САЩ (34)
Emory University Hospital Midtown
Atlanta , Georgia
Emory University Hospital
Atlanta , Georgia
Winship Cancer Institute
Atlanta , Georgia
University of Maryland
Baltimore , Maryland
MSK Basking Ridge
Basking Ridge , New Jersey
Brigham and Women's Hospital
Boston , Massachusetts
Dana-Farber Cancer Institute
Boston , Massachusetts
MSK Commack
Commack , New York
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables , Florida
NOT_YET_RECRUITING
University of Miami Hospital and Clinics Deerfield Beach
Deerfield Beach , Florida
NOT_YET_RECRUITING
Sylvester Comprehensive Cancer Center- Doral
Doral , Florida
NOT_YET_RECRUITING
MSK Westchester
Harrison , New York
Indiana CTSI Clinical Research Center (ICRC)
Indianapolis , Indiana
Indiana University Health University Hospital
Indianapolis , Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)
Indianapolis , Indiana
Dartmouth-Hitchcock Medical Center
Lebanon , New Hampshire
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City , New York
Sylvester Comprehensive Cancer Center
Miami , Florida
NOT_YET_RECRUITING
University of Miami Hospital and Clinics
Miami , Florida
NOT_YET_RECRUITING
Sylvester Comprehensive Cancer Center Kendall
Miami , Florida
NOT_YET_RECRUITING
MSK Monmouth
Middletown , New Jersey
Medical College of Wisconsin
Milwaukee , Wisconsin
NOT_YET_RECRUITING
MSK Bergen
Montvale , New Jersey
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York , New York
Memorial Sloan Kettering Cancer Center - Main Campus
New York , New York
Dana-Farber Cancer Institute - Chestnut Hill
Newton , Massachusetts
Methodist Hospital
Omaha , Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
Omaha , Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha , Nebraska
Sylvester Comprehensive Cancer Center Plantation
Plantation , Florida
NOT_YET_RECRUITING
Fred Hutchinson Cancer Center
Seattle , Washington
NOT_YET_RECRUITING
University of Washington
Seattle , Washington
NOT_YET_RECRUITING
MSK Nassau
Uniondale , New York
University of Massachusetts Chan Medical School
Worcester , Massachusetts
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.02.2024
Крайна дата
09.03.2028
Регистрационен номер
NCT06215118
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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