Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

August 31, 2015

Study Completion Date

February 28, 2017

Conditions
Multiple Myeloma
Interventions
DRUG

Bendamustine

Treatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.

DRUG

Bortezomib

"1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.~Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15"

DRUG

Dexamethasone

20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15

Trial Locations (13)

20817

Center for Cancer and Blood Disorders, Bethesda

National Capital Clinical Research Consortium, Bethesda

23601

Peninsula Cancer Institute, Newport News

29210

South Carolina Oncology Associates, Columbia

33916

Florida Cancer Specialists, Fort Myers

37203

Tennessee Oncology, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

45242

Oncology Hematology Care Inc., Cincinnati

49503

Grand Rapids Clinical Oncology Program, Grand Rapids

70809

Hematology Oncology Clinic, LLP, Baton Rouge

75213

Leading Edge Research, PA, Arlington

76104

The Center for Cancer and Blood Disorders, Fort Worth

91360

Los Robles Hospital and Medical Center, Thousand Oaks

All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

collaborator

Cephalon

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER

NCT01056276 - Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy | Biotech Hunter | Biotech Hunter