Spots Global Cancer Trial Database for A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Official Title: A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Study ID: NCT00478777
Conditions
Study Description
Brief Summary: This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone. This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program in Germany. Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this open-label single-arm study. Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles. Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD) for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany. Upon discontinuation from study, minimal information was collected in order to identify when disease progressed.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medizinische Klinik und Poliklinik II der Charité UniversitÀtsmedizin Berlin Campus Mitte, Berlin, , Germany
Poliklinik I, HÀmatologie/ Onkologie, UniversitÀtsklinikum Bonn, Bonn, , Germany
Johanniter-Krankenhaus Bonn Friedrich-Wilhelm-Stift gGmbH, Bonn, , Germany
Medizinische Klinik StÀdtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Interne Klinik Dr. Argirov, Schön-Kliniken, Burg, , Germany
Klinik fĂŒr Innere Medizin III Klinikum Chemnitz gGmbH, Chemnitz, , Germany
Medizinische Klinik und Poliklinik, Uniklinikum Dresden, Dresden, , Germany
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie, DĂŒsseldorf, , Germany
Direktor der Klinik f. HÀmatologie, UniversitÀtsklinikum Essen, Essen, , Germany
UniversitÀtsklinikum EssenInnere Klinik und Poliklinik, Essen, , Germany
Klinik fĂŒr Innere Medizin, Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder), , Germany
Medizinische Klinik II (ZIM),HĂ€matologie / Onkologie Uniklinik Frankfurt, Frankfurt am Main, , Germany
Abt. Innere Medizin I , HÀmatologie / Onkologie, UniversitÀtsklinikum Freiburg, Freiburg, , Germany
UniversitÀtsklinikum GöttingenHamatologie und Onkologie, Göttingen, , Germany
InterdisziplinĂ€re Klinik und Poliklinik fĂŒr Stammzellentransplantation UniversitĂ€tsklinik Hamburg - Eppendorf, Hamburg, , Germany
II. Medizinische Abteilung, Asklepios Klinikum Altona, Hamburg, , Germany
Abt. HĂ€matologie, HĂ€matologie und Onkologie, Medizinische Hochschule Hannover, Hannover, , Germany
Medizinische Klinik und Poliklinik V Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Klinik fĂŒr Innere Medizin II HĂ€matologie / Onkologie UniversitĂ€tsklinikum Jena, Jena, , Germany
EPS - Early Phase Solutions GmbH, Jena, , Germany
HÀmatologie / Onkologie / Infektionskrankheiten, Palliativmedizin StÀdtisches Klinikum Karlsruhe, Karlsruhe, , Germany
2. Med. Klinik , Sektion f. Stammzell- + Immuntherapie UniversitÀtsklinikum Schleswig-Holstein, Kiel, , Germany
Institut fĂŒr Versorgungsforschung in der Onkologie Praxisklinik fĂŒr HĂ€matologie und Onkologie, Koblenz, , Germany
Ărzte f. Innere Medizin Gemeinschaftspraxis f. HĂ€matologie u. Onkologie, Köln, , Germany
Klinik f. Innere Medizin, Klinikum der UniversitÀt zu Köln, Köln, , Germany
Medizinische Klinik und Poliklinik II Abt. HĂ€matologie / Onkologie, UniversitĂ€tsklinikum Leipzig AĂR, Leipzig, , Germany
III. Med. Klinik, Johannes Gutenberg UniversitÀt, Mainz, , Germany
Klinikum Mannheim der UniversitÀt Heidelberg, Mannheim, , Germany
HĂ€matologisch-Onkologisches Institut fĂŒr medizinische Service Leistungen, Mönchengladbach, , Germany
Medizinische Klinik III Klinikum der UniversitĂ€t MĂŒnchen-GroĂhadern, MĂŒnchen, , Germany
Medizinische Klinik und Poliklinik A, UniversitĂ€tsklinikum MĂŒnster, MĂŒnster, , Germany
FachĂ€rzte fĂŒr Innere Medizin HĂ€matologie und Onkologie Gemeinschaftspraxis, MĂŒnster, , Germany
Onkologie Praxis Oldenburg, Oldenburg, , Germany
Abt. Onkologie/ HĂ€matologie, Klinikum Oldenburg, Oldenburg, , Germany
Abteilung HĂ€matologie und Onkologie, HĂ€matologie und Onkologie, Medizinische Klinik, Klinikum Ernst v. Bergmann, Potsdam, , Germany
Klinikum der UniversitÀt Regensburg, Regensburg, , Germany
Abteilung HÀmatologie und Onkologie, Medizinische FakultÀt der UniversitÀt Rostock, Rostock, , Germany
Caritasklinik St. Theresia, Saarbrucken, , Germany
msÂČ Medizinische Statistik SaarbrĂŒcken, Saarbrucken, , Germany
Med. Klinik III , St. Marienkrankenhaus Siegen, Siegen, , Germany
Zentrum fĂŒr Innere Medizin II Robert- Bosch-Krankenhaus GmBH, Stuttgart, , Germany
Krankenanstalt Mutterhaus der BorromÀerinnen, Trier, , Germany
Abt. II HĂ€matologie, Onkologie und Immunologie Medizinische Klinik Abt.II, TĂŒbingen, , Germany
Medizinische UniversitÀtsklinik, Ulm, , Germany
Praxis Dres. Maintz & GroschekHĂ€matologie / Onkologie, Wuerselen, , Germany
Med. Klinik 1, Helios Klinikum Wuppertal, Wuppertal, , Germany
Med. Klinik u. Poliklinik IIKlinikum der UniversitĂ€t WĂŒrzburg, WĂŒrzburg, , Germany
HĂ€matologisch-onkologische Praxis, WĂŒrzburg, , Germany
Contact Details
Name: Axel Glasmacher, MD
Affiliation: University of Bonn
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
