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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.
Full 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.
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Inclusion criteria
Patients with multiple myeloma according to British Columbia Cancer Agency Criteria
Stage IIA/B or IIIA/B according to Durie/Salmon
Symptomatic or progressive disease
Status of disease:
Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration
Written informed consent
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Interventional model
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Central trial contact
Axel Glasmacher, MD
Data sourced from clinicaltrials.gov
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