Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

October 31, 2009

Study Completion Date

September 30, 2011

Conditions
CancerMultiple Myeloma
Interventions
DRUG

Bortezomib

Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.

DRUG

Melphalan

"All patients received melphalan (100 mg/m\^2/day × 2; days~-3 and -2), for a total dose of 200 mg/m\^2."

PROCEDURE

Autologous PBSC Transplant

Day 0 consists of the stem cell infusion.

Trial Locations (1)

30322

Emory University Winship Cancer Institute, Atlanta

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Emory University

OTHER