Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201695
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2005-09-12
Brief Title:
Liposomal Doxorubicin Vincristine Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Pegylated Liposomal Doxorubicin Doxil Vincristine and Dexamethasone DVd in Combination With Arsenic Trioxide Trisenox in Untreated Patients With Symptomatic Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2015-06
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:
This study will assess the ability of Doxorubicin Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60
Detailed Description:
Rationale The chemotherapy combination of doxorubicin vincristine and dexamethasone DVd has been used with some efficacy in patients with multiple myeloma However DVds efficacy is primarily considered palliative for patients with this condition The current study adds arsenic trioxide to the DVd combo to assess if all of the treatments together improve patient outcomes Previous studies suggest that arsenic trioxide may enhance the efficacy of specific chemotherapy agents including those in DVd however research in people has not yet demonstrated this improved effectiveness Because the safety of arsenic trioxide has been tested in this patient population this phase II study will gather more information about safety and also measure efficacy through various measures
Purpose This study will evaluate the safety and efficacy of doxorubicin vincristine and dexamethasone plus arsenic trioxide in untreated patients with symptomatic multiple myeloma The biology of the tumor and other molecular changes will also be assessed in patients through collections of blood and marrow samples
Treatment Patients in this study will receive arsenic trioxide doxorubicin vincristine and dexamethasone During the first five days of the study patients will be given arsenic trioxide each day through an intravenous infusion No treatments will be provided on days six and seven After this first week patients will then receive study drugs on the following schedule every four weeks doxorubicin and vincristine on day one dexamethasone on days one through four and arsenic trioxide twice each week This schedule can be repeated up to four times for a total of approximately four months Several tests and exams will be given throughout the study to closely monitor patients Supportive care will be provided to help regulate side effects from study drugs and maintain quality of life in patients Treatments will be discontinued due to disease growth or unacceptable side effects
Purpose This study will evaluate the safety and efficacy of doxorubicin vincristine and dexamethasone plus arsenic trioxide in untreated patients with symptomatic multiple myeloma The biology of the tumor and other molecular changes will also be assessed in patients through collections of blood and marrow samples
Treatment Patients in this study will receive arsenic trioxide doxorubicin vincristine and dexamethasone During the first five days of the study patients will be given arsenic trioxide each day through an intravenous infusion No treatments will be provided on days six and seven After this first week patients will then receive study drugs on the following schedule every four weeks doxorubicin and vincristine on day one dexamethasone on days one through four and arsenic trioxide twice each week This schedule can be repeated up to four times for a total of approximately four months Several tests and exams will be given throughout the study to closely monitor patients Supportive care will be provided to help regulate side effects from study drugs and maintain quality of life in patients Treatments will be discontinued due to disease growth or unacceptable side effects
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