Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
NCT ID: NCT00124813
Last Updated: 2010-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2002-08-31
2010-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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thalidomide
idarubicin
oral idarubicin
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Bonn
OTHER
Responsible Party
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University Hospital, Bonn, Germany
Principal Investigators
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Ingo Schmidt-Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bonn
Locations
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Medical Clinic & Policlinic III, University of Bonn
Bonn, , Germany
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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T-CID
Identifier Type: -
Identifier Source: org_study_id
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