Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103506
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2005-02-09
Brief Title:
Study of DOXILCAELYX Pegylated Liposomal Doxorubicin and VELCADE Bortezomib or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Controlled Study of DOXILCAELYX Doxorubicin HCL Liposome Injection and VELCADE Bortezomib or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2015-09
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:
The purpose of this study is to evaluate time to progression overall survival response rate and safety for the two open-label treatment groups DOXILCAELYX in combination with VELCADE vs VELCADE monotherapy
Detailed Description:
This is a randomized study drug assigned by chance parallel-group open-label all involved people know the identity of the intervention multicenter study in 18 countries A total of 646 patients with multiple myeloma whose disease has progressed after an initial response to at least 1 line of prior therapy or was refractory to initial treatment will be enrolled The primary endpoint is time to progression the interval between the date of randomization and the date of disease progression secondary endpoints are overall survival the interval between the date of randomization and the patients death from any cause response rate the proportion of patients in the evaluable population who achieved a complete or partial response and safety Other study endpoints include patient reported outcomes and exploratory pharmacogenics to identify genetic markers of response Patients are assessed for efficacy and safety every 3 weeks until disease progression is documented or for up to 42 weeks from the start of the first dose of study drug Patients who do not progress after the 42-week period are assessed every 6 weeks until disease progression is documented Efficacy evaluations includes serum protein electrophoresis 24-hour urine collection for protein electrophoresis skeletal survey plain films bone marrow biopsy and aspirate clinical or radiologic assessment of plasmacytomas and serum calcium Responses and progressions are assessed objectively by a computer algorithm based on the EBMT criteria Safety evaluations include adverse event reports changes in clinical laboratory findings and tests for cardiac function multiple gated acquisition scanechocardiogram and electrocardiogram Group A VELCADE monotherapy VELCADE 13 milligram per meter square mgm2 to be administered by iv bolus on Days 1 4 8 and 11 of each 21-day cycle Group B DOXILVELCADE combination treated with VELCADE at the same dose and schedule as specified in Group A DOXILCAELYX 30 mgm2 by intravenous infusion given on Day 4 of every 21-day cycle following the administration of VELCADE
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 |
|---|---|---|---|
| 2004-001842-34 | EUDRACT_NUMBER | Janssen Research Development LLC | None |
| DOXILMMY3001 | OTHER | None | None |