NCT01009840

IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients

A Phase 2a Study of Once Daily Intravenous Busulfan With Bortezomib, Followed by an Autologous Hematopoietic Stem Cell Transplant (HSCT) in Subjects With Relapsed Multiple Myeloma After Prior Autologous HSCT

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	IV busulfan	PK-directed dosing of IV busulfan for 4 days
DRUG	bortezomib	Single IV bortezomib at a dose of 1.3 mg/m\^2.
PROCEDURE	Autologous Hematopoietic Stem Cell Transplant (HSCT)

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-11-09
• Last updated: 2014-09-25
• Results posted: 2014-08-07

Locations

13 sites across 2 countries: United States, Canada