Status:
UNKNOWN
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
Lead Sponsor:
University Hospital, Bonn
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 h...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00124813
Start Date
August 1 2002
End Date
November 1 2010
Last Update
February 2 2010
Active Locations (1)
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1
Medical Clinic & Policlinic III, University of Bonn
Bonn, Germany, 53105