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Brief Title: A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official Title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)
Study ID: NCT03859427
Brief Summary: Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Robert A Moss Oncology, Fountain Valley, California, United States
Rocky Mountain Cancer Centers Denver Midtown, Denver, Colorado, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut, Plainville, Connecticut, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Advocate Lutheran General Hospital, Park Ridge, Illinois, United States
New York Oncology Hematology, PC, Albany, New York, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Texas Oncology-Denton, Denton, Texas, United States
US Oncology Research Investigational Products Center, Fort Worth, Texas, United States
Oncology Consultants PA, Houston, Texas, United States
Texas Oncology, San Antonio, Texas, United States
United States Oncology Regulatory Affairs Corporate Office, The Woodlands, Texas, United States
Universitaetsklinikum Salzburg, Salzburg, , Austria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD, Sofia, , Bulgaria
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Helsingin Yliopistollinen Keskussairaala, Helsinki, , Finland
Oulun Yliopistollinen Sairaala, Oulu, , Finland
Turun Yliopistollinen Keskussairaala, Turku, , Finland
Centre Hospitalier Universitaire de Nantes, Nantes, , France
Centre Hospitalier Universitaire Archet 2, Nice cedex 3, , France
Hopital Saint Louis, Paris, , France
Hopital Pitie-Salpetriere, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Benite, , France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie, Poitiers Cedex, , France
Centre Hospitalier Universitaire de Rennes, Rennes, , France
Institut de Cancerologie Strasbourg, Strasbourg, , France
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse cedex 9, , France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois, Vandoeuvre les Nancy Cedex, , France
Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Dresden, , Germany
Universitatsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitatsklinikum Koln, Köln, , Germany
Johannes Gutenberg Universitaet Mainz, Mainz, , Germany
University Hospital of Alexandroupolis, Alexandroupoli, , Greece
General Hospital Evangelismos, Athens, , Greece
Agios Savvas Anticancer Hospital, Athens, , Greece
251 General Airforce Hospital, Athens, , Greece
Alexandra Hospital, Athens, , Greece
Metropolitan Hospital, Athens, , Greece
General University Hospital of Patras Panagia i Voithia, Patra, , Greece
Theagenion Cancer Hospital of Thessaloniki, Thessaloniki, , Greece
General Hospital of Thessaloniki Georgios Papanikolaou, Thessaloniki, , Greece
Nagoya City University Hospital, Nagoya-shi, Aichi, Japan
Toyohashi Municipal Hospital, Toyohashi-shi, Aichi, Japan
Tesshokai Kameda General Hospital, Kamogawa-shi, Chiba, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
Ogaki Municipal Hospital, Ogaki-shi, Gifu, Japan
National Hospital Organization Shibukawa Medical Center, Shibukawa-shi, Gunma, Japan
Japanese Red Cross Society Himeji Hospital, Himeji-shi, Hyogo, Japan
Hyogo College of Medicine Hospital, Nishinomiya-shi, Hyogo, Japan
Hitachi Ltd Hitachi General Hospital, Hitachi-shi, Ibaraki, Japan
University Hospital Kyoto Prefectural University of Medicine, Kyoto-shi, Kyoto, Japan
National Hospital Organization Sendai Medical Center, Sendai-shi, Miyagi, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
National Hospital Organization Okayama Medical Center, Okayama-shi, Okayama, Japan
Japanese Red Cross Osaka Hospital, Osaka-shi, Osaka, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
Osaka University Hospital, Suita-shi, Osaka, Japan
Saitama Medical Center, Kawagoe-shi, Saitama, Japan
Tochigi Cancer Center, Utsunomiya-shi, Tochigi, Japan
Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan
Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution, Kaunas, , Lithuania
Vilnius University Hospital Santaros Clinic Public Institution, Vilnius, , Lithuania
VU Medisch Centrum, Amsterdam, , Netherlands
Gelre Ziekenhuizen, Apeldoorn, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
Fundeni Clinical Institute, Bucharest, , Romania
Institutul Clinic Fundeni, Bucharest, , Romania
Spitalul Clinic Coltea, Bucharest, , Romania
Spitalul Universitar de Urgenta Bucuresti, Bucharest, , Romania
Spitalul Clinic Colentina, Bucuresti, , Romania
Institutul Oncologic Prof Dr Ion Chiricuta, Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Spitalul Clinic Dr Gavril Curteanu Oradea, Oradea, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu, , Romania
Spitalul Clinic Municipal de Urgenta Timisoara, Timisoara, , Romania
Regional Clinical Hospital, Krasnoyarsk, , Russian Federation
Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department, Moscow, , Russian Federation
SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department, Moscow, , Russian Federation
SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov, Petrozavodsk, , Russian Federation
Federal centre of heart, blood and endocrinology Almazova, Saint Petersburg, , Russian Federation
State Budget Educational Institution of High Professional Skills Samara State Medical University, Samara, , Russian Federation
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda, Bratislava, , Slovakia
Hospital Universitari Son Espases, Palma de Mallorca, Baleares, Spain
Hospital Clinico Universitario de Salamanca, Salamanca, Castilla León, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcon, Madrid, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Falu Lasarett, Falun, , Sweden
Sahlgrenska Universitetssjukhuset, Goteborg, , Sweden
Hallands Sjukhus Halmstad, Halmstad, , Sweden
Sunderby Sjukhus, Lulea, , Sweden
Skanes Universitetssjukhus, Lund, , Sweden
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara, , Turkey
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi, Ankara, , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul, , Turkey
Bagcilar Medipol Mega Universite Hastanesi, Istanbul, , Turkey
Istanbul Florence Nightingale Hastanesi, Istanbul, , Turkey
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi, Izmir, , Turkey
Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi, Kayseri, , Turkey
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR