358
Participants
Start Date
November 21, 2013
Primary Completion Date
June 22, 2018
Study Completion Date
January 26, 2022
Rituximab
Rituximab 375mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28 day cycle from Cycles 2 to 5
Lenalidomide
Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles
Placebo
Placebo (identical matched capsule) PO daily on Days 1 to 21 every 28 days
CHU Mont -Godinne, Yvoir
AZ St-Jan Brugge Oostende AV, Bruges
AZ Groeninge, Kortrijk
Local Institution - 371, Ghent
UZ Gent, Ghent
Weill Cornell Medical College, New York
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin, Berlin
SUNY Upstate Medical University, Syracuse
Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum, Berlin
Hospital Universitario Reina Sofia, Córdoba
Local Institution - 314, Córdoba
Pamukkale University Medical Faculty, Denizli
Istituto Europeo di Oncologia - IEO, Milan
Ospedale Niguarda Ca Granda, Milan
Onkologische Schwerpunktpraxis Leer - Emden, Leer
Centre Hospitalier de Valence, Valence
Wake Forest Baptist Health, Winston-Salem
Gaziantep University, Gaziantep
Hospital Universitario Infanta Leonor, Madrid
Hospital Universitario Fundacion Jimenez Diaz, Madrid
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute, Spartanburg
Hospital Costa del Sol, Marbella
Local Institution - 315, Marbella
St Francis Hospital, Greenville
CHRU de Brest - Hopital Morvan, Brest
Hospital Morales Meseguer, Murcia
Local Institution - 318, Murcia
Centro di Riferimento Oncologico - IRCCS, Aviano (PN)
Florida Cancer Specialists North Region Sarah Cannon Research, St. Petersburg
Marmara University, Istanbul
Dokuz Eylul University Izmir, Izmir
Mitchell Cancer Center, University of South Alabama, Mobile
Hospital Universitario de Salamanca, Salamanca
Local Institution - 311, Salamanca
Sarah Cannon Research Inst, Nashville
A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna
University of Louisville, J.G. Brown Cancer Center, Louisville
Hospital Universitario Virgen Del Rocio, Seville
Kliniken Maria Hilf GmbH, Mönchengladbach
Kocaeli Derince Training and Research Hospital, Umuttepe Kocaeli
Azienda Ospedaliero-Universitaria di Parma, Parma
Oncology Hematology Care Sarah Cannon Research, Cincinnati
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola
Ospedale degli Infermi di Rimini, Rimini
Providence Cancer Institute, Southfield
Ospedale di Ravenna, Ravenna
CHU d'Angers, Angers
Iowa Oncology Research Association, Des Moines
19 Mayis Medical Faculty - Samsun, Samsun
Mayo Clinic, Rochester
Coborn Cancer Center at the St. Cloud Hospital, Saint Cloud
Krankenhaus Nordwest, Frankfurt
Illinois Cancer Care, P.C., Peoria
Tel-Aviv Sourasky Medical Center, Tel Aviv
CH Perpignan - Hopital Saint-Jean, Perpignan
Fakultni Nemocnice Ostrava, Klinika hematoonkologie,, Ostrava
Hopital Saint-Louis, Paris
Arlington Cancer Center, Arlington
U.O.C. Ematologia, Barletta
MD Anderson Cancer Center, Houston
Klinkum der Stadt Villingen-Schwenningen GmbH, Villingen-Schwenningen
"IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale", Napoli
Soroka University Medical Center, Beersheba
Arizona Center for Cancer Care, Glendale
CHU de Poitiers, Poitiers
University of New Mexico, Albuquerque
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria
Az. Osp. Vincenzo Cervello, Palermo
Casa di Cura La Maddalena, Palermo
Hadassah University Hospital, Jerusalem
Wilshire Oncology Medical Group, Inc, La Verne
Southwest Cancer Care Medical Group, Escondido
North County Hematology Oncology (NCHO) - TRM, LLC., Oceanside
Wellness Hematology Oncology, West Hills
Hematology-Oncology Medical Group of Orange County, Inc., Orange
Centre Hospitalier Universitaire d'Avicennes, Bobigny
Central Coast Medical Oncology Corporation, Santa Maria
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima, Catania
UC Davis Medical Center, Sacramento
Local Institution - 028, Portland
Providence Portland Medical Center, Portland
Northwest Medical Specialties PLLC, Tacoma
Peking University People's Hospital, Beijing
307 Hospital of PLA, Beijing
Beijing Cancer Hospital, Beijing, PR
Peking Union Medical College Hospital, Beijing
Russian Academy of Medical Sciences Institution, Moscow
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin, Moscow
St. Petersburg Pavlov State Medical University, Saint Petersburg
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, Saint Petersburg
Cancer Hospital, Fudan University, Shanghai
Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University, Nanjing
The First Affiliated Hospital of Soochow University, Suzhou
Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin
The Ministry of Health and Social Development of the Tula region state institution Health Tula regio, Tula
Tianjin Medical University Cancer Institute and Hospital, Tianjin
The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou
Local Institution - 604, Hangzhou
Fujian Medical University Union Hospital, Fuzhou
The Third Xiangya hospital of central south university, Changsha
Sun Yat-sen University Cancer Center, Guangzhou
Guangdong General Hospital, Guangzhou
Local Institution - 600, Guangzhou
West China Hospital of Sichuan University, Chengdu
Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk
Xijing Hospital, Xi'an
Local Institution - 700, Kōtoku
Chugoku Central Hospital, Hiroshima
Marin Oncology Associates, Greenbrae
Cancer Center of Central Connecticut, Southington
LRG Healthcare Oncology Clinic, Laconia
NH Oncology - Hematology, PA, Hooksett
The Cancer Center at Hackensack University Medical Center, Hackensack
Hematology-Oncology Associates of Northern NJ, Morristown
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento, Porto Alegre
Hospital de Clínicas de Porto Alegre, Porto Alegre
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre
Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center, Porto Alegre
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú, Jau/SP
MS INCA HC I Hospital do Cancer I, Rio de Janeiro
Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo
Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo
Fundação Antonio Prudente - AC Camargo Câncer center, São Paulo
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
Interni hematoonkologicka klinika, Brno
Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika, Hradec Králové
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika, Prague
Local Institution - 534, Prague
Vseobecna Fakultni Nemocnice v Praze, Prague
Azienda Ospedaliera S. Andrea - Università La Sapienza, Roma
Local Institution - 340, Roma
Local Institution - 708, Nagasaki
The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki
Local Institution - 709, Minato-ku
Toranomon Hospital, Minatoku
National Cancer Center Hospital, Chūōku
National Cancer Center Hospital East, Kashiwa
Kobe City Medical Center General Hospital, Kobe
The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Kōtoku
University Hospital, Kyoto Prefectural University of Medicine, Kyoto
Nagoya Medical Center,Division of Hematology/Oncology, Nagoya
National University Corporation Tohoku University, Tohoku University Hospital, Sendai
Malopolskie Centrum Medyczne S.C., Krakow
Instytut Hematologii i Transfuzjologii w Warszawie, Warsaw
Local Institution - 514, Warsaw
Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie, Warsaw
Local Institution - 513, Warsaw
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil, Lisbon
Local Institution - 330, Lisbon
Instituto Portugues de Oncologia do Porto, Francisco Gentil, Porto
Local Institution - 331, Porto
Hospital Auxilio Muto Centro de Cancer, San Juan
Hospital de la Santa Creu i Sant Pau, Barcelona
Cukurova University Medical Faculty Balcali Hospital, Adana
Hacettepe Universitesi, Ankara
Eastbourne District General Hospital, Eastbourne
Royal Liverpool University Hospital, Prescot Street, Liverpool
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea
Lead Sponsor
Celgene
INDUSTRY