Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124813
Status:
UNKNOWN
Last Update Posted:
2010-02-02
First Post:
2005-07-27
Brief Title:
Thalidomide Cyclophosphamide Oral Idarubicin and Dexamethasone T-CID in Patients With Multiple Myeloma
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Thalidomide Cyclophosphamide Oral Idarubicin and Dexamethasone T-CID as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
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:
Background In some studies thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma MM In this study the researchers have chosen a regimen which can be administered on an outpatient basis
Induction therapy To evaluate the efficacy and toxicity of thalidomide cyclophosphamide oral idarubicin and dexamethasone T-CID in patients with relapsed or refractory multiple myeloma
Maintenance therapy Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID
Induction therapy To evaluate the efficacy and toxicity of thalidomide cyclophosphamide oral idarubicin and dexamethasone T-CID in patients with relapsed or refractory multiple myeloma
Maintenance therapy Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID
Detailed Description:
Background In some studies thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma MM In this study the researchers have chosen a regimen which can be administered on an outpatient basis
After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression
After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression
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