459
Participants
Start Date
January 31, 2007
Primary Completion Date
November 30, 2009
Study Completion Date
April 30, 2016
Lenalidomide: Double-blind Induction
Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
Melphalan
Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
Prednisone
Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
Aspirin
"Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.~Double-blind maintenance: at the investigator's discretion"
Placebo
"Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles.~Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression."
Lenalidomide: Double-blind Maintenance
Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.
Lenalidomide: Open-label
Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.
Hope Directorate Haematology Oncology Service St. James Hospital, Dublin
Medical University of Vienna, Vienna
AZ-VUB, Brussels
Wilhelminenspital, Vienna
Royal Prince Alfred Hospital, Camperdown
UZ Gasthuisberg, Leuven
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology, East Melbourne
The Alfred Hospital, Melbourne
Frankston Hospital, Frankston
Centre Hospitalier Universitaire de Liege, Liège
Hematology Oncology Clinics of Australia, Level 5, Mater Medical Centre, South Brisbane
Princess Alexandra Hospital, Woolloongabba
Royal Adelaide Hospital Institute of Medical and Veterinary Science, Adelaide
University Hospital of Salzburg St Johanns Spital, Salzburg
Sir Charles Gairdner Hospital, Nedlands
University Hospital Innsbruck, Innsbruck
Medicinsk afd. Vejle Sygehus, Vejle
AZ St-Jan Brugge Oostende AV, Bruges
Hæmatologisk afd. B Aalborg Sygehus Syd, Aalborg
Zhitomir Regional Clinical Hospital, Zhytomyr
Medizinische Klinik und Poliklinik II der Charite Campus Mitte, Berlin
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista, Turin
Hospital Universitaro Puerta del MarServicio de Hematologia, Cadiz
General Air Force Hospital, Athens
Alexandra General Hospital of Athens, Athens
CHU, Caen
A.O.U. San Martino, Genova
Ernst-Moritz-Arndt-Universität Greifswald, Greifswald
Cherkassy Regional Oncology Center, Cherkassy
Dipartmento Oncologico Struttura Complessa di ematlologiaA.O. Ospedale Niguarda Ca Granda, Milan
Medicinska kliniken, Malmo
Policlinico San Matteo Universita Di Pavia, Pavia
Hospital Universitario de la Princessa, Madrid
Rambam Medical Center, Haifa
CHU Montpellier- Hopital Lapeyronie, Montpellier
Marmara School of Medicine, Istanbul
Ege University Medical School, Izmir
Hospital Universitario de Salamanca, Salamanca
Policlinico S. Orsola, Bologna
Hospital Virgen del Rocio Servicio de Hematologia, Seville
Poliklinik A, Münster
Dnepropetrovsk City Clinical Hospital 4, Dnipro
Hematology Institute, Hemato-Oncology Division,Davidoff Cancer Center, Rabin MC Beilinson Hospital, Petch Tikva
The Chaim Sheba Medical Center, Tel Litwinsky
Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V, Heidelberg
Dipartimento di Onco-Ematologia, San Giovanni Rotondo (FG)
Medizinische Klinik - Abteilung II, Tübingen
Assistance Publique - Hôpitaux de Paris AP-HP, Paris
Fakultni Nemocnice Olomouc, Olomouc
Institute of Urgent and Recovery Surgery, Donetsk
CH - Hôpital Dupuytren, Limoges
Medizinische Universitatsklinik, Ulm
Hadassah University Hospital, Jerusalem
Medizinische Klinik und Poliklinik II des Universitatsklinikums Wurzburg, Würzburg
Burdenko Central Military Clinical Hospital, Moscow
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl, Moscow
Moscow Regional Research Institute n.a. Vladimirsky, Moscow
St. Petersburg Research Institute of Hematology and Blood Transfusion, Saint Petersburg
City Clinical Hospital 9, Minsk
Medical Radiological Research Center RAMS, Obninsk
Samara Regional Clinical Hospital, Samara
Novosibirsk State Regional Clinical Hospital, Novosibirsk
Medical University of Vienna, Vienna
Republican Scientific and Practical Centre of Radiation Medicine and Human Ecology, Homyel
Fakultni nemocnice Brno, Brno
Fakultni nemocnice Hradec Kralove, Hradec Králové
Vseobecna Fakultni Nemocnice v Praze, Prague
CHU Purpan, Toulouse
Ltd M.Zodelava Hematology Centre, Tbilisi
Institute of Hematology and Transfusiology, Tbilisi
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden
Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik, Freiburg im Breisgau
Medizinische Klinik und Poliklinik II, Leipzig
G. GENNIMATAS General Hospital of Athens Department of Hematolgosy, Athens
Midlands Regional, Tullamore / Co Offally
Universitair Medisch Centrum Utrecht, Utrecht
Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine, Lviv
Divisione Di Ematologia Ospedale Cattedra di Ematologia, Rome
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma, Rome
VU Medical Center, Amsterdam
Erasmus Medical Center, Rotterdam
Erasmus Medisch Centrum, Rotterdam
Klinika Hematologii Samodzielny Publiczny Szpital Kliniczny Akademii, Bialystok
Institute of Internal Diseases University of Medicine, Gdansk
Oddzial Kliniczny Kliniki Hematologii, Krakow
Uniwersytet Medyczny w Lodzi, Lodz
University School of Medicine, Lublin
Akademia Medyczna w Warszawie Samodzielny Publiczny Centralny Szpital Kliniczny, Warsaw
Hospital Clinic, Barcelona
Medicinkliniken, Borås
UniversitatsSpital ZurichKlinik fur Onkologie, Zurich
Ankara University, Ankara
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases, Kiev
Monklands Hospital, Aidrie
St James's University Hospital, Leeds
University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing, London
Kings College Hospital, London
Christie NHS Trust Hospital, Manchester
Lead Sponsor
Celgene Corporation
INDUSTRY