Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097981
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2004-12-01
Brief Title:
A Study of Thalidomide Plus Dexamethasone Thal-Dex Versus DOXIL plusThalidomide Plus Dexamethasone DOXIL -Thal-Dex 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 Randomized Open-Label Multi-Center Trial Comparing Thalidomide Plus Dexamethasone Thal-Dex Versus DOXIL plusThalidomide Plus Dexamethasone DOXIL -Thal-Dex in Subjects With Newly Diagnosed Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-02
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:
The purpose of this study is to determine if Thalidomide Dexamethasone or DOXIL doxorubicin HCl liposome injection Thalidomide Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma The number of patients whose multiple myeloma disappears for a period of time complete Response will be studied to make the determination of which treatment is more effective
Detailed Description:
This is a multi-center open-label all people know the identity of the intervention randomized the study medication is assigned by chance study to compare the safety and effectiveness of Thalidomide Dexamethasone versus DOXIL doxorubicin HCl liposome injection Thalidomide Dexamethasone in patients with newly diagnosed multiple myeloma Treatments are administered in 28-day cycles Patients will receive 4 to 12 treatment cycles depending on the response of their multiple myeloma to the treatment measured according to the European Group for Blood and Marrow Transplant Response Criteria Patients will have additional tests that include Multiple Gated Acquisition MUGA scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL doxorubicin HCl liposome injection Maximum duration of study participation for each participant will be 48 weeks
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 |
|---|---|---|---|
| DO04-23-006 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |