Conditions: Cancer Multiple Myeloma
Keywords: Cancer Multiple Myeloma Peripheral Blood Stem Cell Transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.

Detailed description:

Arms:
arm 1: Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan. arm 2: Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.

Interventions: intervention 1: Bortezomib intervention 2: Melphalan intervention 3: Autologous PBSC Transplant
Intervention descriptions: intervention 1: Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B. intervention 2: All patients received melphalan (100 mg/m\^2/day × 2; days

-3 and -2), for a total dose of 200 mg/m\^2. intervention 3: Day 0 consists of the stem cell infusion.

Protocol document: