Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Multiple MyelomaPlasma Cell Leukemia
Interventions
DRUG

Bortezomib

the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant

DRUG

Melphalan

Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes

PROCEDURE

PBSCT

PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER