Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

August 31, 2013

Study Completion Date

September 4, 2020

Conditions
Amyloidosis
Interventions
DRUG

Bortezomib

"Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4"

DRUG

Dexamethasone

"Induction:~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days"

DRUG

Melphalan

"Conditioning:~Melphalan 70-100 mg/m2/day IV on days -2 and -1"

Trial Locations (1)

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Boston Medical Center

OTHER