Spots Global Cancer Trial Database for Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
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Trial Identification
Brief Title: Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
Official Title: A Randomised Comparison of Daily 25 mg Versus 5 mg Lenalidomide as Maintenance Therapy After High-dose Therapy and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
Study ID: NCT00891384
Conditions
Study Description
Brief Summary: This trial is a randomised, parallel-group, multicenter phase III study for maintenance therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose therapy and autologous stem cell transplantation as first line therapy.
Detailed Description: High-dose therapy will be performed as first line treatment. After high-dose therapy and autologous stem cell transplantation the patients will be included and randomised. Three month after high-dose therapy all patients will receive consolidation therapy with 6 cycles of lenalidomide 25 mg daily for 21 days every 28 days. Afterwards patients will receive maintenance therapy according to their assigned treatment arm. Randomisation will be performed in a 1:1 ratio to continuous maintenance therapy with either 25mg or 5mg lenalidomide daily for 21 days every 28 days.Randomisation will be stratified by ISS-stage (1+2 vs 3, age (younger than 66 years versus 66 years or older), response after high-dose therapy (CR+vgPR vs PR vs MR/SD. Patients will be treated until disease progression.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medizinische Klinik, Abteilung Innere Medizin, Heidelberg, Baden-Württemberg, Germany
Clinic of Justus-Liebig-University, Medical Clinic for Hematology and Medical Oncology, Giessen, Hessen, Germany
Departement of Hematology, Oncology and Clinical Immunology, Duesseldorf, Northwest, Germany
St. Johannes Hospital, Medical Clinic II, Duisburg, Northwest, Germany
Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf, Hamburg, , Germany
Contact Details
Name: Guido Kobbe, PD Dr.
Affiliation: Departement of Hematology, Oncology and Clinical Immunology
Role: PRINCIPAL_INVESTIGATOR
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