NCT00124813

Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	thalidomide
DRUG	idarubicin	oral idarubicin

Timeline

• Start date: 2002-08-01
• Primary completion: 2010-05-01
• Completion: 2010-11-01
• First posted: 2005-07-28
• Last updated: 2010-02-02

Locations

1 site across 1 country: Germany