54
Participants
Start Date
August 6, 2020
Primary Completion Date
November 30, 2022
Study Completion Date
October 1, 2024
Carfilzomib
Carfilzomib will be administered intravenously over 30 ± 5 minutes, on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression. A dose of 20 mg/m\^2 will be administered on day 1 of cycle 1. All subsequent doses will be 56 mg/m\^2. The frequency of carfilzomib administration will be reduced to day 1 and 15 per cycle starting with cycle 13 and continued until progression or end of study.
Dexamethasone
Dexamethasone will be administered at least 30 minutes, but no more than 4 hours prior to carfilzomib on days of carfilzomib administration. Dexamethasone will be administered at a dose of 40 mg on days 1, 8, 15, and 22 of each 28-day cycle up to progression during cycles 1 to 12. Dexamethasone will be administered at a dose of 20 mg on days 1 and 15 of each 28-day cycle up to progression during cycles 13 onward. For subjects more than or equal to 75 years of age, the dose will be 20 mg during cycles 1 through 12 and 10 mg from cycles 13 onward.
Pomalidomide
Pomalidomide dose will be 4 mg per day orally on days 1 to 21 of each cycle until progression.
Sjaellands Universitetshospital, Roskilde
Vejle Sygehus, Vejle
Aarhus Universitetshospital, Aarhus N
Aalborg Universitetshospital, Aalborg
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette, Torino
General Hospital Evangelismos, Athens
Alexandra Hospital, Athens
North Estonia Medical Centre, Tallinn
Asklepios Klinik Altona, Hamburg
Blue Ridge Cancer Care, Roanoke
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia
General University Hospital of Patras Panagia i Voithia, Pátrai
Hospital Universitario 12 de Octubre, Madrid
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque, Pessac
University of Alabama at Birmingham, Birmingham
Hospital Clinico Universitario de Salamanca, Salamanca
CHU Grenoble Alpes, Grenoble
Centre Hospitalier Universitaire de Nantes, Nantes
Oncology Hematology Care Incorporated, Cincinnati
University Hospital of Ioannina, Ioannina
Hospital Universitari i Politecnic La Fe, Valencia
Universitätsklinikum Münster, Münster
Theagenion Cancer Hospital of Thessaloniki, Thessaloniki
Minnesota Oncology Hematology PA, Saint Paul
General Hospital of Thessaloniki Georgios Papanikolaou, Thessaloniki
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, Lille
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona
Affiliated Oncologists, LLC, Chicago Ridge
Clinique Sainte Anne, Strasbourg
University General Hospital of Evros-Alexandroupolis District, Alexandroupoli
Universitatsklinikum Tubingen, Tübingen
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II, Lecce
Baylor Charles A Sammons Cancer Center at Dallas, Dallas
Texas Oncology- Tyler, Tyler
Texas Oncology, Fort Worth, Fort Worth
Texas Oncology - Austin Midtown, Austin
United States Oncology Regulatory Affairs Corporate Office, Austin
US Oncology Research Investigational Products Center, Austin
Rocky Mountain Cancer Centers Denver Midtown, Denver
Yale Cancer Center, New Haven
Centre Hospitalier de Saint Quentin, Saint-Quentin
Klinikum Chemnitz gGmbH, Chemnitz
Policlinico Universitario Agostino Gemelli, Roma
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital Clinic i Provincial de Barcelona, Barcelona
Lead Sponsor
Amgen
INDUSTRY