Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003603
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
Sponsor:
Riverside Haematology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Study Comparing CIDEX CCNU Oral Idarubicin and Dexamethasone With Melphalan and Prednisolone in Relapsed Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2001-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Steroids such as dexamethasone or prednisolone may help relieve some of the side effects of chemotherapy It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time
Detailed Description:
OBJECTIVES
Compare the response rate response duration and survival of patients with relapsed multiple myeloma after treatment with lomustine idarubicin and dexamethasone vs melphalan and prednisolone
OUTLINE This is a randomized study Patients are stratified according to prior autologous transplant yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive oral lomustine on day 1 oral idarubicin once daily on days 1-3 and oral dexamethasone twice a day on days 1-4 Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression
Arm II Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4 Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression
Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently with chemotherapy in either treatment arm
Quality of life is assessed at baseline at 3 6 9 and 12 months and then every 6 months thereafter
Patients are followed until death
PROJECTED ACCRUAL A total of 660 patients will be accrued for this study within 5 years
Compare the response rate response duration and survival of patients with relapsed multiple myeloma after treatment with lomustine idarubicin and dexamethasone vs melphalan and prednisolone
OUTLINE This is a randomized study Patients are stratified according to prior autologous transplant yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive oral lomustine on day 1 oral idarubicin once daily on days 1-3 and oral dexamethasone twice a day on days 1-4 Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression
Arm II Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4 Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression
Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently with chemotherapy in either treatment arm
Quality of life is assessed at baseline at 3 6 9 and 12 months and then every 6 months thereafter
Patients are followed until death
PROJECTED ACCRUAL A total of 660 patients will be accrued for this study within 5 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 |
|---|---|---|---|
| EU-98030 | None | None | None |
| RHG-MM97 | None | None | None |