Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003493
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Multiple Myeloma
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Doxil Vincristine and Decadron in Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2001-08
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin vincristine and dexamethasone in treating patients with newly diagnosed or previously treated multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin vincristine and dexamethasone in treating patients with newly diagnosed or previously treated multiple myeloma
Detailed Description:
OBJECTIVES I Assess the response rate and duration of response of multiple myeloma treated with doxorubicin HCl liposome vincristine and dexamethasone II Define the qualitative and quantitative toxic effects of this regimen in these patients
OUTLINE Patients are stratified into newly diagnosed group A and previously treated group B patients Patients receive doxorubicin HCl liposome IV over 25 hours followed by vincristine by bolus IV over 5 minutes on day 1 Dexamethasone is administered orally or by IV on days 1-4 Treatment is repeated every 4 weeks for a minimum of 6 courses and 2 courses after maximum response unless unacceptable toxic effects or disease progression occur Patients are followed until death
PROJECTED ACCRUAL A maximum of 33 patients from group A and 34 patients from group B will be accrued for this study within 6-14 months
OUTLINE Patients are stratified into newly diagnosed group A and previously treated group B patients Patients receive doxorubicin HCl liposome IV over 25 hours followed by vincristine by bolus IV over 5 minutes on day 1 Dexamethasone is administered orally or by IV on days 1-4 Treatment is repeated every 4 weeks for a minimum of 6 courses and 2 courses after maximum response unless unacceptable toxic effects or disease progression occur Patients are followed until death
PROJECTED ACCRUAL A maximum of 33 patients from group A and 34 patients from group B will be accrued for this study within 6-14 months
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 |
|---|---|---|---|
| NCI-V98-1459 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066532 | REGISTRY | None | None |
| SEQUUS-CCF-IRB-2006 | None | None | None |