450
Participants
Start Date
October 13, 2009
Primary Completion Date
March 31, 2014
Study Completion Date
May 9, 2018
Lenalidomide
"For patients with normal renal function (defined as CrCl ≥ 60 mL/min), 5 mg once daily on Days 1 through 28 of the first 28-day cycle, 10 mg once daily on Days 1 through 28 starting at the second cycle, 15 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.~For patients with moderate renal impairment (defined as CrCl ≥ 30 to \< 60 mL/min), 2.5 mg once daily on Days 1 through 28 of the first 28-day cycle, 5 mg once daily on Days 1 through 28 starting at the second cycle, 7.5 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first."
Chlorambucil
Patients assigned to the chlorambucil arm will receive oral chlorambucil tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
Institut Jules Bordet, Brussels
Hopital Erasme, Brussels
Medical University of Vienna Internalmedicine 1, Hematology, Vienna
North Shore University Hospital, Takapuna
Military Medical Academy, Sofia
National Specialized Hospital for Active Treatment of Hematology Diseases, Sofia
Rigshospitalet University Hospital, Copenhagen
Spaame Ziekenhuis, Hoofddorp
University Witwatersrand Oncology, Parktown
Calvary Mater Hospital, Waratah
Herlev University Hospital Dep of hematology, Harlev
Nepean Hospital, Kingswood, NSW
UZ Leuven, Leuven
Western Hospital, Footscray
Royal Melbourne Hospital, Melbourne
St. Vincent Hospital, Fitzroy
Roskilde University Hospital, Roskilde
University hospital Sveti Georgi Hematology Clinic, Plovdiv
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen
Princess Alexandra Hospital, Woolloongabba
IMVS, Adelaide
Flinders Medical Centre, Bedford Park
CHU Mont -Godinne, Yvoir
Maxima Medisch Centrum, Eindhoven
MHAT Georgi Stranski PlevenHematology Clinic, Pleven
Universitaetsklinik Innsbruck, Innsbruck
Szegedi TudomanyegyetemII Belgyogyaszati Klinika, Szeged
Hopital de Jolimont, Haine-Saint-Paul
Kaposi Mor Oktato Korhaz, Kaposvár
Christchurch Hospital, Christchurch
AZ Groeninge, Kortrijk
University hospital Sveta Marina, Varna
Petz Aladar Country Hospital, Vasvari Pal U. 2
General Hospital Sveti Duh, Zagreb
Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju, Zagreb
University Hospital Centre Zagreb, Zagreb
AOU San Luigi Gonzaga, Orbassano
New York Medical College, Valhalla
Roswell Park Cancer Center, Buffalo
Clinical Center Nis, Niš
Ha'Emek Medical Center, Afula
Geisinger Health System, Wilkes-Barre
Drexel University, College of Medicine, Philadelphia
Pottstown Memorial Medical Center, Pottstown
Berks Hematology-Oncology Associates, West Reading
Hospital Donostia, Donostia / San Sebastian
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan
Ospedale San Raffaele S.r.l., Milan
Istituto Europeo di Oncologia - IEO, Milan
University Hospital Centre Split, Split
Western Galilee Hospital, Nahariya
Hospital Universitario de la Princesa, Madrid
Hospital Ramon y Cajal, Madrid
Universita del Piemonte Orientale, Novara
Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda
Charleston Hematology Oncology P.A., Charleston
South Carolina Cancer Specialists, Hilton Head Island
Hospital General Universitario Morales Messeguer, Murcia
Bnei Zion Medical Center, Haifa
Bergonie Institut, Bordeaux
Polyclinique Bordeaux Nord Aquitaine, Bordeaux
Clinical Center Kragujevac, Kragujevac
Universita degli Studi di Padova, Padua
Hospital Universitario de Salamanca, Salamanca
CHRU, Grenoble
Hospital Universitario Marques de Valdecilla, Santander
Azienda Ospedaliero Universitaria di Modena, Modena
Purchase Cancer Group, Paducah
Meir Medical Center, Kfar Saba
Gabrail Cancer Center Research, Canton
Hospital Universitario La Fe, Valencia
Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services, New Albany
Medical Consultants, PC, Muncie
Rabin Medical Center, Petah Tikva
Azienda Ospedaliera Universitaria Careggi, Florence
Sheba Medical Center, Tel Litwinsky
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena
Columbia St Marys Cancer Center, Milwaukee
Ospedale S. Chiara, Pisa
Ospedale Umberto I, Torrette Di Ancona
North Chicago VA Medical Center, North Chicago
University Hematology Oncology Inc., Centralia
Saint Louis University Cancer Center, St Louis
Tel Aviv Sourasky Medical Center Department of Hematology, Tel Aviv
CHU Hautepierre, Strasbourg
Azienda Ospedaliera Policlinico di Bari, Bari
Fakultni nemocnice Ostrava, Ostrava
Kaplan Medical Center, Rehovot
Central Texas Veterans Health Care System, Temple
Barzilai Medical Center, Ashkelon
Ospedale Cardarelli, Naples
Narodny onkologicky ustav, Bratislava
Soroka University Medical Center, Beersheba
Azienda Ospedaliera Ospedale San Carlo, Potenza
CHU Dupuytren, Limoges
Nevada Cancer Research Foundation, Las Vegas
Innovative Clinical Research Institute, Whittier
Shaare Zedek Medical Center, Jerusalem
California Cancer Associates for Research and Excellence cCARE, Escondido
Swedish Tumor Institute, Seattle
Providence St. Mary Regional Cancer Center, Walla Walla
Russian Academy of Medical Sciences Institution, Moscow
Moscow GUZ City Clinical Hospital, Moscow
NUZ Central Clinical Hospital, Moscow
Archangelsk Regional Clinical Hospital, Arkhangelsk
St. Petersburg Research Institute of Hematology and Blood Transfusion, Saint Petersburg
GUS Leningrad Regional Clinical Hospital, Saint Petersburg
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, Saint Petersburg
Spitalul Clinic Municipal de Urgenta Timisoara, Timișoara
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu
GUZ Nizhegorodskaya Regional Clinical Hospital, Nizhny Novgorod
Regional Clinical Hospital 1, Yekaterinburg
MUZ City clinical hospital, Novosibirsk
City Hospital 8, Barnaul
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi, Iași
Instituto Oncologico, Reñaca
Instituto Clinico Oncologico del Sur ICOS, Temuco
The Hospital of Central Connecticut, New Britain
Cancer Center of Central Connecticut, Southington
University of Minnesota, Minneapolis
Oncology and Hematology Associates, PA, Denville
The Cancer Center, Hackensack University Medical Center, Hackensack
Somerset Hematology-Oncology Associates, Somerville
Westmead Hospital Australia, Westmead
Monte Tabor - Hospital Sao Rafael, Salvador
BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A, Belo Horizonte
Hospital de Clínicas de Porto Alegre, Porto Alegre
Hospital Nossa Senhora da Conceicao, Porto Alegre
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos
Hospital Universitario de Brasilia, Brasílía
Hospital Erasto Gaertner, Curitiba
Pro Onco Centro de Tratamento Oncologico, Londrina
Hospital Israelita Albert Einstein, Morumbi
Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO, Rio de Janeiro
Instituto Nacional de Cancer - INCA, Rio de Janeiro
Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC, Santo André
Instituto de Ensino e Pesquisa Sao Lucas, São Paulo
Fundação Antonio Prudente - AC Camargo Câncer center, São Paulo
Regional Health Authority B-Saint John Regional Hospital, Saint John
General Hospital, Eastern Health, St. John's
Hospital Charles LeMoyne, Greenfield Park
Sacre-Couer Hospital, Montreal
Oncomedica S.A., Montería
Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza, Tatabánya
Mary Potter Oncology Centre, Pretoria
University Hospital2.Dep.Intern.Med. Hematology, Hradec Králové
Faculty Hospital Kralovske Vinohrady, Prague
Hopital de l'Archet 1, Nice
Isala Klinieken, Zwolle
Uniwersyteckie Centrum Kliniczne, Gdansk
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika, Lodz
Specjalistyczny Szpital miejski im. Kopernika, Torun
Klinika Chorob wewnetrznych i Hematologii, Warsaw
Nowotworww Krwi i Transplantacji Szpiku, Wroclaw
Hospitais da Universidade de Coimbra, Coimbra
Instituto Portugues Oncologia do Porto Francisco Gentil EPE, Porto
Institutul Clinic Fundeni, Bucharest
Spitalul Clinic Coltea, Bucharest
Martinska Fakultna Nemocnica, Martin
Pretoria Academic Hospital, Pretoria
Hospital Germans Trias I Pujol, Badalona
Hospital Universitario Vall D hebron, Barcelona
Royal Bournemouth General Hospital, Bournemouth
St. Bartholomew's and The Royal London Hospital, London
St George's Healthcare NHS Trust, London
Lead Sponsor
Celgene
INDUSTRY