Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib

PHASE3TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

April 28, 2017

Study Completion Date

April 28, 2017

Conditions
AL Amyloidosis
Interventions
DRUG

Bortezomib

"Conditioning Regimen:~Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1"

DRUG

Melphalan

"Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0"

DRUG

Neupogen

granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

PROCEDURE

Stem Cell Collection

collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

PROCEDURE

Stem cell infusion

infusion of previously collected autologous stem cells

Trial Locations (1)

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Boston Medical Center

OTHER