Multiple Myeloma
Conditions
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.
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.
Interventions
DRUGthalidomide
DRUGidarubicin
oral idarubicin
Sponsors
University Hospital, Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction therapy: response rate, overall survival, death rate | — |
| Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Primary ContactAxel Glasmacher, MD
Outcome results
None listed