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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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