Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,623

Participants

Timeline

Start Date

August 21, 2008

Primary Completion Date

July 14, 2016

Study Completion Date

July 14, 2016

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide and low-dose dexamethasone

"Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD.~Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression"

DRUG

Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles

"lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles.~Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles"

DRUG

Melphalan, Prednisone and Thalidomide

Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles

Trial Locations (288)

7

Mater Misercordiae Hospital, Dublin

24

Adelaide and Meath Hospital, Dublin

124

Attiko Hospital of Athens, Athens

1000

Jules Bordet Institut, Brussels

1011

Centre Hospitalier Universitaire Vaudois CHUV, Lausanne

1020

Hospital of the Barmherzigen Bruder Vienna, Vienna

1023

Auckland City Hospital, Auckland

1070

Hopital Erasme, Brussels

1090

AZ-VUB, Brussels

1160

MM-015.Wihelminenspital, Vienna

1200

Cliniques Universitaires St-Luc, Brussels

2065

Royal North Shore Hospital, St Leonards

2069

ZNA Stuivenberg Centrumziekenhuis, Antwerp

2145

Westmead Hospital, Wentworthville

2250

Gosford Hospital, Gosford

2500

Wollongong Hospital, Wollongong

2650

Universitair Ziekenhuis Antwerpen, Edegem

3000

Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Leuven

3002

Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology, East Melbourne

3010

Inselsspital Bern, Bern

3011

Western Hospital, Footscray

3050

The Royal Melbourne Hospital, Parkville

3100

Hospital St. Polten, Sankt Pölten

3144

Cabrini Hospital, Malvern

3199

Frankston Hospital, Frankston

3220

Geelong Hospital, Geelong

3500

Virga Jesse Ziekenhuis, Hasselt

3690

Border Medical Oncology, Wodonga

4010

Hospital of Barmherzige Schwestern Linz, Linz

Hospital of Elisabethinen Linz, Linz

4021

General Hospital Linz, Linz

4029

Royal Brisbane and Women's Hospital, Herston

4031

UniversitatsSpital Basel, Basel

4102

Princess Alexandra Hospital, Woolloongabba

4215

Gold Coast Hospital, Southport

4600

Hospital Wels, Wels

5000

Royal Adelaide Hospital, Adelaide

5001

Abteilung Onkologie Haematologie des Kantonsspitals Aarau, Aarau

5020

MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III, Salzburg

5042

Flinders Medical Centre, Bedford Park

5530

Cliniques Universitaires UCL de Mont-Godine, Yvoir

6000

Royal Perth Hospital, Perth

6021

Wellington Hospital, Newtown

6700

Les Cliniques du Sud Luxembourg, Arlon

7000

Kantonsspital Graubunden, Chur

7198

Hospital Son Llatzer, Palma de Mallorca

8000

AZ St-Jan Brugge Oostende AV, Bruges

8011

Christchurch Hospital, Christchurch

8400

Kantonsspital Winterthur, Winterthur

8596

Kantonsspital Munsterlingen, Münsterlingen

8700

Hospital Leoben, Leoben

8800

H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat, Roeselare

8916

Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona)

9000

UZ Gent, Ghent

10002

National Taiwan University Hospital, Tapei

10126

Ospedale Molinette, Torino

11042

Arena Oncology Associates, PC, Lake Success

11217

Veteran General Hospital - Taipei, Taipei

11528

Alexandra Hospital, University of Athens, Athens

12027

CHG Rodez, Rodez

13009

Institut Paoli-Calmettes, Marseille

14004

Hospital Reina Sofia, Córdoba

14033

CHU, Caen

14076

Centre Francois Baclesse, Caen

15706

Hospital Clinico Santiago de Compostela, Santiago de Compostela

16132

Clinica Ematologica, A.O.U. San Martino di Genova, Genova

17007

Hospital Univ. Josep Trueta, Girona

17487

Ernst-Moritz-Arndt-Universität Greifswald, Greifswald

18057

Medizinische Fakultat der Universitat Rostock, Rostock

18104

St. Luke's Hospital and Health Network, Allentown

18537

Metaxa Hospital Peiraias, Piraeus

19104

University of Pennsylvania, Philadelphia

20014

Hospital de Donosti, Donostia / San Sebastian

20099

Askepios Klinik St. Georg, Hamburg

20132

U.O. di Ematologia e Trapianto di Midollo Osseo, Milan

20141

Istituto Europeo di Oncologia - IEO, Milan

Presidio Ospedaliero A. Perrino, Milan

20817

Center for Cancer and Blood Disorders, Bethesda

21034

CHRU Hopital du bocage, Dijon

22027

Centre Hospitalier Yves Le Foll, Saint-Brieuc

23538

Universitatsklinikum schleswig-Holstein, Lübeck

27100

Policlinico San Matteo Universita Di Pavia, Pavia

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Clinico Virgen de la Victoria, Málaga

29100

Ospedale Civile, Piacenza

29609

Hopital Augustin Morvan, Brest

30008

Hospital General Universitario Morales Messeguer, Murcia

31008

Clinica Universitaria de Navarra,, Pamplona

32073

Integrated Community Oncology Network, Orange Park

32207

Baptist Cancer Institute, Jacksonville

32607

Gainesville Heme Oncology Associates, Gainesville

33076

Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, Bordeaux

33300

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

33401

Palm Beach Cancer Institute, LLC, West Palm Beach

33604

CHRU - Hopital du Haut Leveque, Pessac

33705

Gulf Coast Oncology, St. Petersburg

34295

CHU Montpellier - Hôpital Lapeyronie, Montpellier

35033

CHRU Hôpital de Pontchaillou, Rennes

35056

CHRU Hopital sud Medecine Interne, Rennes

35294

University of AL Birmingham, Birmingham

35385

Universitatsklinikum Giessen, Giessen

37044

CHRU Hopital Bretonneau, Tours

CHRU Hopital Trousseau, Tours

38017

The Cancer Center, Collierville

38034

Institut Prive de Cancerologie, Grenoble

38043

CHRU, Grenoble

38104

University of Tennessee Cancer Institute, Memphis

39008

Hospital Universtario Marques de Valdecilla, Santander

40138

Policlinico S. Orsola, Bologna

40225

Universitaetsklinikum Dusseldorf Klinik fuer Haematologie, Düsseldorf

40447

China Medical University Hospital, Taichung

41016

Centre Hospitalier, Blois

41100

Policlinico di Modena, Modena

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

42270

Institut de Cancerologie de Loire, Saint-Priest-en-Jarez

43201

Hospital Sant Pau, Reus

44035

CHRU - Hotel Dieu, Nantes

44106

University Hospitals of Cleveland, Cleveland

44195

Cleveland Clinic, Cleveland

44718

Gabrail Cancer Center Research, Canton

45000

CH La Source, Orléans

45122

Universitatsklinikum Essen-, Essen

46009

Hosptial La Fe, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

48129

Poliklinik A, Münster

49033

CHRU Hopital du bocage, Angers

50009

Hospital Clinico Universitario Lozano Blesa, Zaragoza

Hospital Miguel Servet, Zaragoza

51032

Hopital R. Debre, Reims

51100

CHU Reims - Hôpital Maison Blanche, Reims

54511

CHRU Hôpitaux de Brabois, Vandœuvre-lès-Nancy

55905

Mayo Clinic Cancer Center, Rochester

56017

CH P. Chubert, Vannes

56126

A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia, Pisa

57085

Hopital de Mercy, Metz

58103

Dakota Cancer Institute, Fargo

59000

GH de Institut Catholique St Vincent, Lille

59037

CHRU-Hopital Claude Huriez, Lille

59107

Billings Clinic, Billings

59385

Centre Hospitalier General, Dunkirk

60611

Orchard Healthcare Research, Inc., Chicago

60612

John H Stroger Hospital of Cook County, Chicago

Rush University Medical Center, Chicago

62801

Southern Illinois Hematology Oncology, Centralia

63000

Chu Estaing, Clermont-Ferrand

64109

Centre Hospitalier de la cote basque, Bayonne

65929

Staedtische Kliniken Frankfurt am Main Hochst, Frankfurt am Main

67098

CHRU Hôpital de Hautepierre, Strasbourg

67124

Cancer Center of Kansas, Wichita

68000

Hopital Emile Muller, Mulhouse

68024

CH Louis Pasteur, Colmar

69008

Centre Leon Berard, Lyon

69437

CHU Hopital Edouard Herriot, Lyon

69495

Centre Hospitalier de Valence, Lyon

71321

Centre Hospitalier William Morey, Chalon/Saone Cedex

72000

Centre Jean Bernard, Le Mans

72037

Centre Hospitalier, Le Mans

72076

Medizinische Klinik - Abteilung II, Tübingen

73100

Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce, Lecce

75010

Hopital Saint Louis, Paris

75015

Hopital Necker, Paris

75100

Unità Operativa di Oncoematologia, Ospedale di Matera, Matera

75571

CHU Hôpital St-Antoine, Paris

75679

Hopital Cochin, Paris

76000

Hopital J MonodRhumato Nord, Le Havre

76038

Centre Henri Becquerel, Rouen

78157

CH, Le Chesnay

80054

CHU Sud, Amiens

80131

Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

81000

Clinique Claude BernardOncologie, Albi

81377

Klinikum der Johann-Wolfgang-Goethe-Universtat, München

Medizinische Klinik III Klinikum der Universität München-Großhadern, München

82017

Clinique Pont de chaume Oncologie et Radiotherapie, Montauban

85925

Centre Hospitalier Departemental, La Roche-sur-Yon

86021

CU CHU Clemenceau, Poitiers

87042

CH - Hôpital Dupuytren, Limoges

88100

Oncologia Medica, Università della Magna Grecia, Catanzaro

89081

Klinik fur Innere Medizin III, Ulm

90048

Cedar Sinai Medical Center Dept of Medicine, Los Angeles

90146

Casa di Cura La Maddalena, Divisione di Ematologia, Palermo

92141

Hopital Antoine Beclere, Clamart

Hopital dinstruction des armees Percy, Clamart

92210

Centre Rene Huguenin, Saint-Cloud

93009

Hopital Avicenne, Bobigny

94010

Hopital Henri Mondor, Créteil

94143

University of California, San Francisco- California, San Francisco

94305

Stanford University Stanford, Stanford

94805

Institut Gustave Roussy, Villejuif

95100

CH Argenteuil Victor Dupouy, Argenteuil

95303

CH Rene Dubois, Cergy-Pontoise

97227

Kaiser Permanente Northwest Oncology Hematology, Portland

98104

Swedish Cancer Institute, Seattle

98109

Fred Hutchinson Cancer Center, Seattle

100020

Chaoyang Hospital, Beijing

100044

Peking University People's Hospital, Beijing

200025

Ruijin Hospital Shanghai Jiaotong University, Shanghai

300041

Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Tianjin

610041

West China Hospital of Sichuan University, Chengdu

942975

Kremlin Bicetre, Le Kremlin-Bicêtre

60426-3558

Ingalls Cancer Institute, Harvey

04074

Maine Center for Cancer Medicine Blood Disorders, Scarborough

77555-0561

University of Texas Medical Branch, Galveston

A-1090

MM-015. Medizinische Universität Wien, Vienna

Unknown

Hospital Wiener Neustadt, Wiener Neustadt

Evangelismos Hospital of Athens, Athens

University of Athens, Athens

Hospital de Sao Marcos, Braga

Hospital de Santo Antonio- Porto, Porto

T2N 2T9

University of Calgary, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

British Columbia Cancer Agency, Kelowna

V3M 1X4

Royal Columbian Hospital, New Westminster

V3V 1Z2

BC Cancer Agency - Fraser Valley Centre, Surrey

V5Z 1M9

Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp, Vancouver

V8R 6V5

Vancouver Island Cancer Center, Victoria

E2L 3L6

Saint John Regional Hospital, Saint John

B3H2Y9

Queen Elizabeth II Health Sciences Center, Halifax

L8V 5C2

Juravinski Cancer Centre, Hamilton

N6A 4G5

London Health Science Centre, London

K1H 8L6

Ottawa Hospital, Ottawa

M4N 3M5

Odette Cancer Centre, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

J4V 2H1

Hospital Charles LeMoyne, Greenfield Park

H7M 3L9

Hopital de la Cite-de-la-Sante, Laval

G5V 3Z1

Hotel-Dieu de Levis, Lévis

G4H 1C5

Hopital du Sacre-Coeur de Montreal, Montreal

H1T 2M4

Hospital Maisonneuve - Rosemont, Montreal

H2L4M1

CHUM- Hopital Notre-Dame, Montreal

H2W 1S6

McGill University, Montreal

H3T 1E2

Sir Mortimer B. Davis - Jewish Genl, Montreal

G1R 2J6

CHUQ - Hotel-Dieu de QuebecHematology - Oncology, Québec

01012

Hopital de Fleyriat, Bourg-en-Bresse

06401

CH, Cannes

06050

Centre Antoine Lacassagne Oncologie medicale et Hematologie, Nice

06202

Hopital de lArchet 1, Nice

TSA 40031-31059

CHRU Hopital Purpan, Toulouse

D-01307

Medizinische Kinik und Poliklinik I, Dresden

07740

Universitatsklinikum Jena, Jena

04103

Medizinische Klinik und Poliklinik II, Leipzig

D -70376

Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH, Stuttgart

540 07

Theagenio Anticancer Hospital of Thessaloniki, Thessaloniki

ST46QG

University Hospital Galway, Galway

00144

Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali, Roma

00161

Azienda Policlinico Umberto I, Universita La Sapienzadi Roma, Rome

3000-075

Hospitais da Universidade de Coimbra, Coimbra

1099-023

Instituto Portugues de Oncologia de Lisboa, Lisbon

1649-035

Hospital de Santa Maria, Lisbon

4200-072

Instituto Português de Oncologia Porto, Porto

431-070

Hallym University Sacred Heart Hospital, Anyang

614-735

Inje University Busan Paik Hospital, Busan

705-718

Daegu Catholic University Medical Center 3056-6, Daegu

301-721

Chungnam National University Hospital, Daejeon

410-769

National Cancer Center, Gyeonggi-do

519-803

Hwasun Chonnam National University Hospital, Hwasun-goon

405-760

Gachon University Gil Hospital, Incheon

561-712

Chonbuk National University Hospital 42, Jeonju

463-707

Seoul National University Bundang Hospital, Seongnam

120-752

Severance Hospital, Seongsanno

110-744

Seoul National University Hospital, Seoul

135-710

Samsung Medical Center, Seoul

137-701

The Catholic University of Korea Seoul - Saint Mary's Hospital, Seoul

138-736

Asan Medical Center, Seoul

158-710

Ewha Womans University Mokdong Hospital, Seoul

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08907

Instituto Catalan de Oncologia-Hospital Duran, Barcelona

SE 581 85

Linkoping University Hospital, Linköping

SE 17176

Karolinska University HospitalSolna, Stockholm

SE- 11281

St. Görans Hospital, Stockholm

SE-14186

Karolinska University Hospital Huddinge, Stockholm

LL57 2PW

Gwynedd Hospital, Bangor

BA1 3NG

Royal United Hospital, Bath

BT9 7AB

Belfast City Hospital Haematology Department, Belfast Northern Ireland

B15 2TH

Birminghman QE, Birmingham West Midlands

BH7 7DW

Royal Bournemouth Hosp, Bournemouth Dorset

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

CB2 2QQ

Addenbrooke's Hospital, Cambridge

CF14 4XW

University Hospital of Wales - Cardiff, Cardiff

G12 0YN

The Beatson West of Scotland Centre, Glasgow

EC1A 7BE

Dept of Haematology St Bartholomews Hospital, London

SE1 9RT

Guy's and St Thomas' Hospital - London, London

W12 0HS

Royal Free Hospital, London

OX3 7LI

Churchhill Hospital, Oxford

PL6 8DH

Derriford Hospital, Plymouth Crownhill Devon

S10 2JF

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust, Sheffield

WF1 4DG

Pinderfields General Hospital, West Yorkshire

WV10 OPQ

New Cross Hospital- Wolverhampton, Wolverhampton

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