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

 -  refractory disease after standard induction therapy

 -  OR relapse after standard induction therapy

 -  OR relapse after high-dose chemotherapy/stem cell transplantation

 -  OR patients with plasma cell leukemia

 -  Patients with measurable paraprotein in urine or serum or quantifiable bone marrow
 infiltration

 -  Written informed consent

 Exclusion Criteria:

 -  Age < 18 years

 -  Life expectancy of less than 3 months

 -  Intolerance to the study drugs

 -  No change or progressive disease after prior therapy with idarubicin or
 cyclophosphamide

 -  Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4

 -  Acute infection

 -  Actually decompensated diabetes mellitus

 -  Total bilirubin > 3.0 mg/dl

 -  Pregnant or breast-feeding women

 -  Polyneuropathy grade 2 or higher

 -  Ulcus ventriculi or duodeni

 -  Narrow or open angle glaucoma

 -  Not-compensated psychiatric diseases

 -  Prior erythroblastopenia

 -  Prior therapy with investigational drugs within the last 4 weeks