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COMPLETED
NCT01009840
PHASE2

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2010-05-01

Completion Date

2012-03-01

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

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)

Locations (13)

Arizona Cancer Center

Tucson, Arizona, United States

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Maryland School of Medicine - Marlene & Stewart Greenebaum Cancer Center

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Pennsylvania -Abramson Cancer Center

Philadelphia, Pennsylvania, United States

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

South Texas Veterans Health Care System

San Antonio, Texas, United States

Texas Transplant Physician Group, PLLC

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada