Ignite Creation Date:
2025-12-18 @ 9:23 AM
Ignite Modification Date:
2025-12-18 @ 9:23 AM
Study NCT ID:
NCT01009840
Status:
None
Last Update Posted:
2014-09-25 00:00:00
First Post:
2009-11-06 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Assessment of the safety profile of this conditioning regimen will also be completed.
Detailed Description:
None
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?: