Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: thalidomide Type: Drug
Name: idarubicin Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: 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 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
Location
Medical Clinic & Policlinic III, University of Bonn
Bonn, Germany
Status: Recruiting
Contact: Ingo Schmidt-Wolf, MD - +49-228-287-15507 - picasso@uni-bonn.de
Start Date
August 2002
Completion Date
November 2010
Sponsors
University Hospital, Bonn
Source
University Hospital, Bonn
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page