NCT00520767 - Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

October 31, 2010

Study Completion Date

June 6, 2019

Conditions

Primary Systemic AmyloidosisLight Chain Deposition Disease

Interventions

DRUG

bortezomib

Bortezomib 1.3 mg/m2 days 1, 8, 15, 22

DRUG

dexamethasone

Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23

DRUG

melphalan

Melphalan 9 mg/m2/day days 1-4

GENETIC

microarray analysis

≤28 days prior to enrollment

OTHER

flow cytometry

Day 1 of cycles 6, 12, 18 and at end of study.

OTHER

laboratory biomarker analysis

≤28 days prior to enrollment

PROCEDURE

quality-of-life assessment

Start of each cycle

Trial Locations (7)

15232

UPMC Cancer Centers, Pittsburgh

27710

Duke Comprehensive Cancer Center, Durham

48075

Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

80218

Rocky Mountain Cancer Centers/Rocky Mountain Blood & Marrow Transplant Program, Denver

02118

Boston University Cancer Research Center, Boston

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

Barbara Ann Karmanos Cancer Institute

OTHER