Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504101
Status:
WITHDRAWN
Last Update Posted:
2016-12-15
First Post:
2007-07-17
Brief Title:
Bortezomib Arsenic Trioxide and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Phase I Clinical Trial of Dose Escalated Bortezomib ATO Arsenic Trioxide Melphalan as a Conditioning Regimen for Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Temporarily closed to accrual pending availablity of drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as arsenic trioxide and melphalan work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving high-dose combination chemotherapy together with bortezomib may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib when given together with arsenic trioxide and melphalan in treating patients undergoing an autologous stem cell transplant for multiple myeloma
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib when given together with arsenic trioxide and melphalan in treating patients undergoing an autologous stem cell transplant for multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Evaluate toxicity of a conditioning treatment regimen comprising bortezomib arsenic trioxide and melphalan
Secondary
Evaluate response and overall survival
Determine what correlative laboratory and clinical parameters if any are associated with efficacy eg serum arsenic trioxide intracellular glutathione depletion gene profiling of myeloma cells
OUTLINE This is a dose-escalation study of bortezomib
Conditioning regimen Bortezomib will be given on days -6 -4 and -2 arsenic trioxide will be given on days -6 -5 -4 -3 and -2 total of 5 doses and melphalan will be given on day -2
Stem cell infusion On day 0 a minimum of autologous 2 x 106 CD34 cellskg will be infused by central catheter
After completion of study therapy patients are followed periodically for at least 5 years
Primary
Evaluate toxicity of a conditioning treatment regimen comprising bortezomib arsenic trioxide and melphalan
Secondary
Evaluate response and overall survival
Determine what correlative laboratory and clinical parameters if any are associated with efficacy eg serum arsenic trioxide intracellular glutathione depletion gene profiling of myeloma cells
OUTLINE This is a dose-escalation study of bortezomib
Conditioning regimen Bortezomib will be given on days -6 -4 and -2 arsenic trioxide will be given on days -6 -5 -4 -3 and -2 total of 5 doses and melphalan will be given on day -2
Stem cell infusion On day 0 a minimum of autologous 2 x 106 CD34 cellskg will be infused by central catheter
After completion of study therapy patients are followed periodically for at least 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCCC-2006071 | OTHER | University of Miami Sylvester Comprehensive Cancer Center | None |