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

Condition	Intervention	Phase
Multiple Myeloma	Drug: thalidomide	Phase II

Further Study Details: 

Primary Outcomes: Induction therapy:; - Response Rate; - Overall survival; - Death rate; Maintenance therapy:; - Progression-free survival; - Overall survival; - Number of patients discontinuing therapy due to toxicity
Secondary Outcomes: Induction therapy:; - Number of patients discontinuing therapy due to toxicity; - Number of patients experiencing toxicity grade 3 or 4; Maintenance therapy:; - Dose intensity; - Number of patients experiencing toxicity grade 3 or 4
Expected Total Enrollment:  80

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, we 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00124813

Axel Glasmacher, MD      +49-228-287-5507    glasmacher@uni-bonn.de

Germany
      Medical Clinic & Policlinic I, University of Bonn, Bonn,  53105,  Germany; Recruiting

Study chairs or principal investigators

Axel Glasmacher, MD,  Principal Investigator,  University of Bonn   

Study ID Numbers:  T-CID
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124813
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-02