Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Bone marrow transplant Stem cell transplant Busulfan Bortezomib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.

Detailed description:
Evaluation of six-month response in relapsed multiple myeloma subjects, who have had a prior autologous HSCT (greater than one year previously) receiving an IV busulfan-based conditioning regimen with the combination of pharmacokinetic (PK)-guided IV busulfan dosing and bortezomib, followed by a second autologous HSCT.

Assessment of the safety profile of this conditioning regimen will also be completed.

Arms:
arm 1: Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m\^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.

Interventions: intervention 1: IV busulfan intervention 2: bortezomib intervention 3: Autologous Hematopoietic Stem Cell Transplant (HSCT)
Intervention descriptions: intervention 1: PK-directed dosing of IV busulfan for 4 days intervention 2: Single IV bortezomib at a dose of 1.3 mg/m\^2. intervention 3: None

Protocol document: