Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

646

Participants

Timeline

Start Date

June 20, 2011

Primary Completion Date

September 2, 2014

Study Completion Date

April 21, 2021

Conditions
LymphomaMultiple Myeloma
Interventions
DRUG

Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone (Oral)

"On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug.~On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug"

DRUG

Dexamethasone (IV)

"On weeks without Elotuzumab dosing: Not Applicable (N/A)~On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug"

BIOLOGICAL

Elotuzumab (BMS-901608; HuLuc63)

Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Trial Locations (216)

7

Local Institution, Dublin

1000

Local Institution, Brussels

1020

Local Institution, Brussels

1090

Local Institution, Brussels

1125

Local Institution, Budapest

1200

Local Institution, Brussles

1211

Local Institution, Geneva

1220

Local Institution, Vienna

2060

Local Institution, Antwerp

2100

Local Institution, Copenhagen

2605

Local Institution, Canberra

2640

Local Institution, Albury

2650

Local Institution, Edegem-antwerp

3004

Local Institution, Melbourne

3010

Local Institution, Bern

3144

Local Institution, Malvern

4000

Local Institution, Liège

4101

Local Institution, South Brisbane

4400

Local Institution, Steyr

4600

Local Institution, Wels

5000

Local Institution, Adelaide

Local Institution, Odense C

5530

Local Institution, Yvoir

6009

Local Institution, Nedlands

6150

Local Institution, Murdoch

6830

Local Institution, Rankweil

7100

Local Institution, Vejle

9024

Local Institution, Győr

10016

NYU Clinical Cancer Center, New York

10019

Local Institution, New York

10065

Weill Cornell Medical College, New York

10126

Local Institution, Torino

11528

Local Institution, Athens

12200

Local Institution, Berlin

13125

Local Institution, Berlin

14000

Local Institution, Caen

15224

Western Pennsylvania Hospital, Pittsburgh

15706

Local Institution, Santiago de Comp-coruna

16132

Local Institution, Genova

18015

Local Institution, Bethlehem

18101

Local Institution, Afula

20133

Local Institution, Milan

20246

Local Institution, Hamburg

22328

Local Institution, Bucharest

22408

Hematology-Oncology Associates Of Fredricksburg, Inc, Fredericksburg

22763

Local Institution, Hamburg

24105

Local Institution, Kiel

24127

Local Institution, Bergamo

28006

Local Institution, Madrid

28007

Local Institution, Madrid

28054

Gaston Hematology & Oncology, Gastonia

28204

Levine Cancer Institute, Charlotte

29414

Local Institution, Charleston

29615

Local Institution, Greenville

30008

Local Institution, Murcia

30322

Winship Cancer Institute., Atlanta

30912

Georgia Health Science University, Augusta

31059

Local Institution, Toulouse

32796

Local Institution, Titusville

32804

Cancer Institute Of Florida, Orlando

33076

Local Institution, Bordeaux

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33401

Florida Cancer Specialists, West Palm Beach

33486

Local Institution, Boca Raton

34390

Local Institution, Istanbul

34613

Cancer Care Centers Of Florida, Brooksville

34652

Local Institution, New Port Richey

35037

Local Institution, Marburg

35100

Local Institution, Izmir

35330

Local Institution, Izmir

35661

Northwest Alabama Cancer Center, Pc, Muscle Shoals

37007

Local Institution, Salamanca

37044

Local Institution, Tours

37909

Local Institution, Knoxville

38120

The West Clinic, Memphis

38700

Local Institution, La Tronche

40138

Local Institution, Bologna

40207

Local Institution, Louisville

40503

Local Institution, Lexington

41016

Local Institution, Blois

41110

Local Institution, Larissa

41501

Pikeville Medical Center, Pikeville

44093

Local Institution, Nantes

45004

Local Institution, Toledo

45500

Local Institution, Ioannina

46260

Local Institution, Indianapolis

46545

Local Institution, Mishawaka

47014

Local Institution, Meldola

47923

Local Institution, Rimini

48100

Local Institution, Ravenna

48149

Local Institution, Münster

48202

Henry Ford Health System, Detroit

49100

Local Institution, Petah Tikva

50134

Local Institution, Florence

50937

Local Institution, Cologne

52242

Local Institution, Iowa City

53226

Medical College of Wisconsin, Milwaukee

53792

University Of Wisconsin Hospital And Clinics, Madison

54511

Local Institution, Vandœuvre-lès-Nancy

54601

Gundersen Clinic, Ltd, La Crosse

58501

Local Institution, Bismarck

59037

Local Institution, Lille

59071

Local Institution, Hamm

60077

Orchard Healthcare Research Inc., Skokie

60126

Local Institution, Ancona

63110

Washington University School Of Medicine, St Louis

63739

Local Institution, Aschaffenburg

65101

Capitol Comprehensive Cancer Care Center, Jefferson City

65807

Local Institution, Springfield

66421

Local Institution, Hamburg

69120

Local Institution, Heidelberg

69495

Local Institution, Pierre Benita

70300

Local Institution, Ẕerifin

70503

Cancer Center Of Acadiana At Lafayette General, Lafayette

71101

Local Institution, Shreveport

71103

Local Institution, Shreveport

Willis Knighton Cancer Center, Shreveport

72076

Local Institution, Tübingen

73104

University Of Oklahoma Health Sciences Center, Oklahoma City

74136

Local Institution, Tulsa

75012

Local Institution, Paris

76100

Local Institution, Rehovot

77030

University Of Texas Md Anderson Cancer Ctr, Houston

77090

Northwest Cancer Center, Houston

78412

Cancer Specialists Of South Texas, Pa, Corpus Christi

81377

Local Institution, München

81675

Local Institution, München

85715

Acrc/Arizona Clinical Research Center, Inc., Tucson

85925

Local Institution, La Roche-sur-Yon

87042

Local Institution, Limoges

88212

Local Institution, Ravensburg

89081

Local Institution, Ulm

89106

Local Institution, Las Vegas

90095

Ucla-Division Of Hematology/Oncology, Los Angeles

90146

Local Institution, Palermo

91120

Local Institution, Jerusalem

91505

Local Institution, Burbank

92024

San Diego Pacific Oncology& Hematology Associates, Inc, Encinitas

92123

Sharp Clinical Oncology Research, San Diego

92140

Local Institution, Clamart

92868

Medical Oncology Care Associates, Orange

92879

Compassionate Cancer Res Grp, Corona

Local Institution, Corona

94589

Local Institution, Vallejo

94704

Local Institution, Berkeley

94904

Local Institution, Greenbrae

97080

Local Institution, Würzburg

98108

Va Puget Sound Health Care System, Seattle

500152

Local Institution, Brasov

700106

Local Institution, Brasov

1138677

Local Institution, Bunkyo-Ku

1358550

Local Institution, Koto-ku

1508935

Local Institution, Shibuya-ku

1608582

Local Institution, Shinjuuku-ku

3770280

Local Institution, Shibukawa-shi

4418570

Local Institution, Toyohashi

4600001

Local Institution, Nagoya

4678602

Local Institution, Nagoya

5438555

Local Institution, Osaka

7011192

Local Institution, Okayama

9518566

Local Institution, Niigata

02215

Dana Farber Cancer Inst, Boston

Dana-Farber Cancer Institute, Boston

11794-8151

Local Institution, Stony Brook

75390-8565

Ut Southwestern Medical Center, Dallas

T2N 4N2

Local Institution, Calgary

T6G 1Z2

Local Institution, Edmonton

B3H 2Y9

Local Institution, Halifax

N6A 4G5

Local Institution, London

M5G 2M9

Local Institution, Toronto

H4J 1C5

Local Institution, Montreal

S7N 4H4

Local Institution, Saskatoon

L4M 6M2

Local Institution, Barrie

H4A 3J1

Local Institution, Montreal

625 00

Local Institution, Brno

500 05

Local Institution, Hradec Králové

100 34

Local Institution, Prague

128 08

Local Institution, Prague

09113

Local Institution, Chemnitz

01307

Local Institution, Dresden

07747

Local Institution, Jena

H-4032

Local Institution, Debrecen

H-6725

Local Institution, Szeged

Unknown

Local Institution, Tullamore

00161

Local Institution, Roma

00168

Local Institution, Roma

371-8511

Local Institution, Maebashi

0608543

Local Institution, Sapporo

980-8754

Local Institution, Sendai

296-8602

Local Institution, Kamogawa

260-8677

Local Institution, Chiba

812-8582

Local Institution, Fukuoka

602-8566

Local Institution, Kyoto

15-276

Local Institution, Bialystok

41-500

Local Institution, Chorzów

20-081

Local Institution, Lublin

60-569

Local Institution, Poznan

02-106

Local Institution, Warsaw

02-507

Local Institution, Warsaw

02-776

Local Institution, Warsaw

50-367

Local Institution, Wroclaw

00716

Local Institution, Ponce

00918

Local Institution, San Juan

030171

Local Institution, Bucaresti

08916

Local Institution, Badalona-Barcelona

06620

Local Institution, Ankara

LE1 5WW

Local Institution, Leicester

EC1A 7BE

Local Institution, London

M20 4BX

Local Institution, Manchester

ML6 OJS

Local Institution, Airdrie

EH4 2XU

Local Institution, Edinburgh

NG5 1PB

Local Institution, Nottingham

SM2 5PT

Local Institution, Sutton

LS9 7FT

Local Institution, Leeds

NW1 2PG

Local Institution, London

NE7 7DN

Local Institution, Newcastle upon Tyne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY