Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma
Trial Information
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Induction therapy: response rate, overall survival, death rate
Safety Issue:
Yes
Principal Investigator
Ingo Schmidt-Wolf, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Bonn
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
T-CID
NCT ID:
NCT00124813
Start Date:
August 2002
Completion Date:
November 2010
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
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