Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006232
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2000-09-11
Brief Title:
Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
Sponsor:
West of Scotland Lymphoma Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2007-03
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 It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma
PURPOSE This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma
PURPOSE This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma
Detailed Description:
OBJECTIVES
Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine doxorubicin and dexamethasone
Compare the disease progression time to achieve maximal response and duration of response in patients treated with these 2 regimens
Compare the quality of life of patients treated with these 2 regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral idarubicin and oral dexamethasone daily on days 1-4 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients also receive oral dexamethasone daily on days 8-11 during course 1 only
Arm II Patients receive oral dexamethasone daily doxorubicin IV continuously and vincristine IV continuously on days 1-4 Courses repeat as in arm I Patients receive additional dexamethasone as in arm I
Patients without a maximal response after completion of course 4 may receive up to 2 additional courses
Quality of life is assessed at baseline and then prior to each study course
Patients are followed for survival
PROJECTED ACCRUAL A total of 200 patients 100 per arm will be accrued for this study within 2 years
Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine doxorubicin and dexamethasone
Compare the disease progression time to achieve maximal response and duration of response in patients treated with these 2 regimens
Compare the quality of life of patients treated with these 2 regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral idarubicin and oral dexamethasone daily on days 1-4 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients also receive oral dexamethasone daily on days 8-11 during course 1 only
Arm II Patients receive oral dexamethasone daily doxorubicin IV continuously and vincristine IV continuously on days 1-4 Courses repeat as in arm I Patients receive additional dexamethasone as in arm I
Patients without a maximal response after completion of course 4 may receive up to 2 additional courses
Quality of life is assessed at baseline and then prior to each study course
Patients are followed for survival
PROJECTED ACCRUAL A total of 200 patients 100 per arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068156 | REGISTRY | None | None |
| EU-20032 | None | None | None |
| ISRCTN65684689 | Registry Identifier | PDQ Physician Data Query | None |