Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

May 30, 2014

Study Completion Date

April 21, 2017

Conditions
Multiple Myeloma
Interventions
BIOLOGICAL

Elotuzumab

Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until subject meets criteria for discontinuation of study drug

DRUG

Bortezomib

Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets; Oral; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets; Oral; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug

Trial Locations (77)

161

Local Institution, Roma

10126

Local Institution, Torino

15224

The Western Pennsylvania Hospital, Pittsburgh

15706

Local Institution, Santiago Compostela

16132

Local Institution, Genova

17033

Penn State Hershey Cancer Institute, Hershey

Penn State Hershey Cancer Inst, Hershey

18015

Cancer Care Associates, Bethlehem

20132

Local Institution, Milan

21204

Local Institution, Baltimore

21229

St. Agnes Hospital, Baltimore

22031

Local Institution, Fairfax

25123

Local Institution, Brescia

27518

Waverly Hematology Oncology, Cary

28006

Local Institution, Madrid

29425

Medical University Of South Carolina, Charleston

29615

Local Institution, Greenville

30008

Local Institution, Murcia

31059

Local Institution, Toulouse

32256

Cancer Specialists of North FL, Jacksonville

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33401

Palm Beach Cancer Institute, West Palm Beach

37007

Local Institution, Salamanca

38043

Local Institution, Grenoble

40138

Local Institution, Bologna

40536

University Of Kentucky Markey Cancer Center, Lexington

41124

Local Institution, Modena

41501

Pikeville Medical Center Leonard Lawson Cancer Center, Pikeville

41701

Local Institution, Hazard

44093

Local Institution, Nantes

45004

Local Institution, Toledo

46010

Local Institution, Valencia

46026

Local Institution, Valencia

46260

Investigative Clinical Research Of Indiana, Llc, Indianapolis

47014

Local Institution, Meldola (fc)

47900

Local Institution, Rimini

48100

Local Institution, Ravenna

48202

Henry Ford Health System, Detroit

50009

Local Institution, Zaragoza

50134

Local Institution, Florence

54500

Local Institution, Vandœuvre-lès-Nancy

59037

Local Institution, Lille

60068

Oncology Specialists, S.C., Park Ridge

60126

Local Institution, Ancona

60637

University Of Chicago Medical Center, Chicago

61801

Local Institution, Urbana

62526

Local Institution, Decatur

63110

Washington University School Of Medicine, St Louis

65124

Local Institution, Pescara

65807

Mercy Medical Research Institute, Springfield

70124

Local Institution, Bari

70503

Cancer Center Of Acadiana, Lafayette

71101

Local Institution, Shreveport

72037

Local Institution, Le Mans

73100

Local Institution, Lecce

75012

Local Institution, Paris

75246

Charles A. Sammons Cancer Center, Dallas

77090

Northwest Cancer Center, Houston

89106

Southern Nevada Cancer Research Foundation, Las Vegas

90033

USC Norris Comprehensive Cancer Center, Los Angeles

90095

Ucla Department Of Medicine, Los Angeles

90806

Local Institution, Long Beach

92123

Sharp Clinical Oncology Research, San Diego

92868

Medical Oncology Care Associates, Orange

92879

Compassionate Cancer Res Grp, Corona

Local Institution, Corona

94589

Kaiser Permanente Medical Center, Vallejo

Local Institution, Vallejo

96819

Kaiser Permanente-Moanalua Medical Center, Honolulu

98108

Local Institution, Seattle

02215

Dana-Farber Cancer Institute, Boston

01608

Local Institution, Worcester

B3H 2Y9

Local Institution, Halifax

00144

Local Institution, Roma

Local Institution, Rome

00168

Local Institution, Roma

08003

Local Institution, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY