Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148317
Status:
COMPLETED
Last Update Posted:
2017-07-18
First Post:
2005-09-02
Brief Title:
Phase II Study of Velcade Decadron and Doxil Followed by Cyclophosphamide in Multiple Myeloma
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Sequential Phase II Trial of the Combination of Bortezomib VELCADE Dexamethasone DECADRON and Pegylated Liposomal Doxorubicin DOXIL Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients
Status:
COMPLETED
Status Verified Date:
2017-06
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:
PRIMARY STUDY OBJECTIVES
To evaluate the efficacy of the combination of bortezomib dexamethasone with and without DOXIL followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients
1 Patients post first line therapy
2 Patients with relapsedrefractory disease who are bortezomib-naïve
To evaluate the safety of the combination of bortezomib and dexamethasone with and without DOXIL followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma
SECONDARY STUDY OBJECTIVES
To evaluate the role of the combination of bortezomib dexamethasone with and without DOXIL followed by high-dose cyclophosphamide on the ability to collect 10 x 106 CD34 cellskg in 7 collections for both subsets of multiple myeloma patients
To evaluate the survival of patients who receive the combination of bortezomib dexamethasone with and without DOXIL followed by high-dose cyclophosphamide for both subsets of patients
To evaluate the efficacy of the combination of bortezomib dexamethasone with and without DOXIL followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients
1 Patients post first line therapy
2 Patients with relapsedrefractory disease who are bortezomib-naïve
To evaluate the safety of the combination of bortezomib and dexamethasone with and without DOXIL followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma
SECONDARY STUDY OBJECTIVES
To evaluate the role of the combination of bortezomib dexamethasone with and without DOXIL followed by high-dose cyclophosphamide on the ability to collect 10 x 106 CD34 cellskg in 7 collections for both subsets of multiple myeloma patients
To evaluate the survival of patients who receive the combination of bortezomib dexamethasone with and without DOXIL followed by high-dose cyclophosphamide for both subsets of patients
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?:
None