A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma
This randomized Phase II clinical study is designed to examine the safety and efficacy of
Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple
myeloma. Subjects must have failed at least one, but no more than three, prior cytotoxic
therapies prior to study registration and may not have relapsed or progressed within one
year following hematopoietic stem cell transplantation. Patients will be randomized to
treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine
followed by Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each
arm. Patients will be followed for six months following treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mark W Frohlich, MD
Study Chair
Xcyte Therapies
United States: Food and Drug Administration
XT005
NCT00078065
November 2003
June 2004
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
University of California, San Francisco | San Francisco, California 94143 |
Oregon Health Sciences University | Portland, Oregon |
University of California, San Diego | La Jolla, California 92037-1709 |
Johns Hopkins Medical Institute | Baltimore, Maryland 21231 |
Center for Cancer & Blood Disorders | Bethesda, Maryland 20817 |
Oncotherapeutics | Los Angeles, California 90067 |