Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078065
Status:
COMPLETED
Last Update Posted:
2005-11-11
First Post:
2004-02-18
Brief Title:
Xcellerated T CellsTM in Patients With Multiple Myeloma
Sponsor:
Xcyte Therapies
Organization:
Xcyte Therapies
Study Overview
Official Title:
A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None