Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Induction therapy: response rate, overall survival, death rate []
- Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with multiple myeloma according to British Columbia Cancer Agency Criteria
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Stage IIA/B or IIIA/B according to Durie/Salmon
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Symptomatic or progressive disease
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Status of disease:
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refractory disease after standard induction therapy
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OR relapse after standard induction therapy
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OR relapse after high-dose chemotherapy/stem cell transplantation
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OR patients with plasma cell leukemia
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Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration
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Written informed consent
Exclusion Criteria:
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Age < 18 years
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Life expectancy of less than 3 months
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Intolerance to the study drugs
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No change or progressive disease after prior therapy with idarubicin or cyclophosphamide
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Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4
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Acute infection
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Actually decompensated diabetes mellitus
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Total bilirubin > 3.0 mg/dl
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Pregnant or breast-feeding women
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Polyneuropathy grade 2 or higher
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Ulcus ventriculi or duodeni
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Narrow or open angle glaucoma
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Not-compensated psychiatric diseases
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Prior erythroblastopenia
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Prior therapy with investigational drugs within the last 4 weeks
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Clinic & Policlinic III, University of Bonn | Bonn | Germany | 53105 |
Sponsors and Collaborators
- University Hospital, Bonn
Investigators
- Principal Investigator: Ingo Schmidt-Wolf, MD, University of Bonn
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- T-CID