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Brief Title: A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma
Official Title: A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma
Study ID: NCT03312530
Brief Summary: This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety run-in phase of the study. Once the dose levels have demonstrated acceptable safety during this phase, randomization will begin for all treatment arms (Arms A, B, and C).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno, , Czechia
Fakultni nemocnice Ostrava; Klinika hematoonkologie, Ostrava, , Czechia
Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze - 1; Lekarska Fakulta - I, Prague 2, , Czechia
Rigshospitalet; Hæmatologisk Klinik, København Ø, , Denmark
Odense Universitetshospital, Odense C, , Denmark
CHU - Hôtel Dieu hematolgie clinique, Nantes, , France
Hôpital Saint-Louis, Paris, , France
CHU Lyon - Centre Hospitalier Lyon Sud, Pierre-Benite (Lyon), , France
IGR, Villejuif, , France
UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V, Heidelberg, , Germany
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik, Mainz, , Germany
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II, Tübingen, , Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III, Ulm, , Germany
Amsterdam UMC Location AMC, Amsterdam, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Førde sentralsjukehus, Førde, , Norway
Oslo University Hospital HF, Rikshospitalet, Oslo, , Norway
Medical University School; Dept. of Haematology, Lodz, , Poland
Uniwersytet Medyczny im.Karola Marcinkowskiego w Poznaniu, Pozna?, , Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology, Warszawa, , Poland
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona, Barcelona, Spain
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario de la Princesa, Madrid, , Spain
Hospital Univ 12 de Octubre, Madrid, , Spain
Skånes Universitetssjukhus, Lund, , Sweden
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR