Xcellerated T CellsTM in Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT00078065
- Lead Sponsor
- Xcyte Therapies
- Brief Summary
This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.
15 patients in each study arm will be followed for 6 months.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Oncotherapeutics
🇺🇸Los Angeles, California, United States
University of California, San Diego
🇺🇸San Diego, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Johns Hopkins Medical Institute
🇺🇸Baltimore, Maryland, United States
Center for Cancer & Blood Disorders
🇺🇸Bethesda, Maryland, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Oncotherapeutics🇺🇸Los Angeles, California, United States