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Набира участници Фаза 1/2 NCT03761108

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Multiple Myeloma

Спонсор: Regeneron Pharmaceuticals

Налично на: БГ
Обобщение
The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving linvoseltamab * How linvoseltamab works in the body * How much linvoseltamab is present in the blood * How linvoseltamab may work to treat cancer
Кой може да участва
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol. * Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either: a. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor (PI). Refractory disease is defined as lack of response or relapse within 60 days of last treatment. * Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. * Phase 2 (Cohorts 1 and 2): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Phase 2 (Cohort 3): Patients with MM whose disease meets the following criteria: 1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR 2. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy. AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then: • Treatment with a CAR-T must have been associated with a response of PR or better, and • If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with linvoseltamab. Key Exclusion Criteria: 1\. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients with known MM brain lesions or meningeal involvement 3. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) 4. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excluded and BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3. 5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment Note: Other protocol defined inclusion / exclusion criteria apply
Интервенции
Linvoseltamab
DRUG
Места на провеждане 40
Белгия (2)
ZNA Psychiatrisch Ziekenhuis Stuivenberg
Antwerp
Cliniques Universitaires Saint-Luc
Brussels
Германия (3)
Universitatsklinikum Essen
Essen , North Rhine-Westphalia
COMPLETED
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz , Rhineland-Palatinate
COMPLETED
Universitatsklinikum Wurzburg
Würzburg
COMPLETED
Япония (10)
Saitama Medical University International Medical Center
Hidaka , Saitama
COMPLETED
Ibaraki Prefectural Central Hospital
Kasama-shi , Ibaraki
National Cancer Center Hospital East
Kashiwa-shi , Chiba
University Hospital Kyoto Prefectural Univ of Medicine
Kyoto , Kyoto
Gunma University Hospital
Maebashi , Gunma
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya , Aichi-ken
COMPLETED
Nagoya City University Hospital
Nagoya , Aichi-ken
Japanese Red Cross Medical Center
Shibuya-ku , Tokyo
COMPLETED
Tokushima Prefectural Central Hospital
Tokushima , Tokushima
Keio University Hospital
Tokyo
Южна Корея (4)
National Cancer Center Korea
Goyang
Seoul National University Cancer Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Yonsei University College of Medicine, Severance Hospital
Seoul
Испания (6)
Hospital de la Santa Creu i Sant Pau
Barcelona , Catalonia
Universitary Hospital La Princesa
Madrid , Salamanca
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario 12 de Octubre
Madrid
Clinica Universidad de Navarra
Pamplona , Navarre
Hospital Clinico Universitario de Salamanca
Salamanca
Великобритания (1)
Royal Marsden Hospital
Sutton , Surrey
WITHDRAWN
САЩ (14)
C. S. Mott_University of Michigan
Ann Arbor , Michigan
ACTIVE_NOT_RECRUITING
Emory University Hospital
Atlanta , Georgia
Ohio State University James Cancer Hospital
Columbus , Ohio
Barbara Ann Karmanos Cancer Center
Detroit , Michigan
ACTIVE_NOT_RECRUITING
University of Texas MD Anderson Clinic
Houston , Texas
ACTIVE_NOT_RECRUITING
Indiana University_Michigan Street
Indianapolis , Indiana
ACTIVE_NOT_RECRUITING
Norton Cancer Institute
Louisville , Kentucky
Sylvester Comprehensive Cancer Center
Miami , Florida
ACTIVE_NOT_RECRUITING
Rutgers Cancer Institute of New Jersey
New Brunswick , New Jersey
ACTIVE_NOT_RECRUITING
Icahn School of Medicine at Mount Sinai
New York , New York
Columbia University Medical Center
New York , New York
ACTIVE_NOT_RECRUITING
Oregon Health and Science University (OHSU) Marquam Hill Campus
Portland , Oregon
Swedish Cancer Institute
Seattle , Washington
Moffitt Cancer Center - McKinley Drive
Tampa , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.01.2019
Крайна дата
16.06.2033
Регистрационен номер
NCT03761108
Източник
clinicaltrials.gov
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