Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

January 6, 2012

Primary Completion Date

March 21, 2014

Study Completion Date

July 18, 2016

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets, Oral, 40 mg, weekly, on days 8, 15 \& 22 (cycle 1); days 8 \&22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug

BIOLOGICAL

Elotuzumab (BMS-901608; HuLuc63)

Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Trial Locations (11)

10021

Weill Cornell Medical College, New York

10029

Mount Sinai Medical Center, New York

21201

University Of Maryland, Baltimore

30322

Winship Cancer Institute, Emory University, Atlanta

37203

Tennessee Oncology, Pllc, Nashville

46260

Investigative Clinical Research Of Indiana, Llc, Indianapolis

48201

Karmanos Cancer Institute, Detroit

52242

University Of Iowa Hospitals And Clinics, Iowa City

63110

Washington University School Of Medicine, St Louis

77030

The University Of Texas M.D. Anderson Cancer Center, Houston

98108

Va Puget Sound Health Care System, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY