Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344422
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2006-06-23
Brief Title:
Vincristine DOXIL Doxorubicin HCl Liposome Injection and Dexamethasone vs Vincristine Doxorubicin and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multi-Center Randomized Study of Vincristine Doxil and Dexamethasone vs Vincristine Doxorubicin and Dexamethasone in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-04
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:
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine DOXIL doxorubicin HCl liposome injection and Dexamethasone VDD versus the standard treatment of Vincristine Doxorubicin and Dexamethasone VAD
Detailed Description:
This is a randomized open label study comparing the efficacy clinical benefit toxicity and safety of the combination of Vincristine DOXIL doxorubicin HCl liposome injection and Dexamethasone VDD to the standard regimen of Vincristine Doxorubicin and Dexamethasone VAD in patients with newly diagnosed multiple myeloma Approximately 200 patients with newly diagnosed multiple myeloma will be randomized to receive either VDD or VAD This study will determine and compare the objective response rate the percentage of patients who attain an Objective Status of Complete Remission Remission or Partial Remission for patients receiving VDD vs VAD This study will also evaluate and compare the clinical benefit of VDD vs VAD for the following measures Hospitalization Documented sepsis Antibiotic use Grade 3 or 4 neutropenia or neutropenic fever
VDD Vincristine 14 mgm2 IV on Day 1 Doxil 40 mgm2 IV on Day 1 Dexamethasone 40 mgday oral Days 1-4 VAD Vincristine 04 mgday continuous infusion Days 1-4 Doxorubicin 90 mgm2day continuous infusion Days 1-4 Dexamethasone 40 mgday orally on Days 1-4 Every 28 days for 4 cycles
VDD Vincristine 14 mgm2 IV on Day 1 Doxil 40 mgm2 IV on Day 1 Dexamethasone 40 mgday oral Days 1-4 VAD Vincristine 04 mgday continuous infusion Days 1-4 Doxorubicin 90 mgm2day continuous infusion Days 1-4 Dexamethasone 40 mgday orally on Days 1-4 Every 28 days for 4 cycles
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