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

• Status: Unknown status
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bonn
• Treatments: BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Idarubicin; Thalidomide

Criteria

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