Spots Global Cancer Trial Database for A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma
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Trial Identification
Brief Title: A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma
Official Title: A Randomized Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma
Study ID: NCT02495922
Conditions
Study Description
Brief Summary: Trial in patients with newly diagnosed myeloma to evaluate the effect of elotuzumab in induction and consolidation therapy with bortezomib/lenalidomide/dexamethasone and in lenalidomide maintenance treatment
Detailed Description: Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for patients with confirmed diagnosis of untreated multiple myeloma requiring systemic therapy . Investigational Medicinal Products:Elotuzumab, lenalidomide Patients are randomized in one of 4 study arms (A1, A2, B1, B2). Patients randomized in arm A1 or A2 will receive 4 cycles VRD (Bortezomib (VelcadeÂź), Lenalidomide (RevlimidÂź), Dexamethasone). Patients in arm B1 or B2 will additionally receive the monoclonal antibody Elotuzumab in the 4 cycles VRD. After induction therapy patients undergo intensifying therapy according to GMMG standard (usually mobilization therapy followed by stem cell collection and autologous stem cell transplantation). After intensification a consolidation therapy will be performed with two cycles VRD (A1 und B1) or VRD+ Elotuzumab (A2 und B2), followed by Lenalidomide maintenance therapy with (arm A2 and B2) or without (arm A1 and B1) additional Elotuzumab. Maintenance therapy will be performed for 2 years. Primary objective is the determination of the best of four treatment strategies regarding progression-free survival (PFS), defined as time from randomisation to progression or death from any cause whichever occurs first. The duration of the trial for each patients is expected to be 36-39 months (induction and intensification treatment: 7-10 months, 3 months rest between intensification and start of consolidation, consolidation 2 months, maintenance phase 24 months).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Studienzentrum Aschaffenburg, Aschaffenburg, , Germany
MVZ Onkologie gGmbH der Klinikum Mittelbaden gGmbH, Baden-Baden, , Germany
HELIOS Klinikum, Klinik fĂŒr HĂ€matologie, Onkologie und Immunologie, Berlin, , Germany
Onkologisches MVZ Berlin Tegel, Berlin, , Germany
Charité Campus Benjamin Franklin, III. Med. Abt. (HÀmatologie/Onkologie), Berlin, , Germany
Klinikum Bielefeld, Klinik fĂŒr HĂ€matologie, Onkologie und Palliativmedizin, Bielefeld, , Germany
Studiengesellschaft Onkologie Bielefeld GbR, Bielefeld, , Germany
HĂ€matologisch-onkologische Schwerpunktpraxis, Bochum, , Germany
Medizinische UniversitÀtsklinik, Knappschaftskrankenhaus, Bochum, , Germany
UniversitÀtsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, HÀmatologie und Rheumatologie, Bonn, , Germany
ZAHO, Zentrum fĂŒr ambulante HĂ€matologie und Onkologie, Bonn, , Germany
Schwerpunktpraxis fĂŒr Onkologie/HĂ€matologie, Bottrop, , Germany
Klinikum Chemnitz GmbH, Innere Medizin III, Chemnitz, , Germany
Onkologisches Studienzentrum Darmstadt, Darmstadt, , Germany
Klinikum Darmstadt, Med. Klinik V, HĂ€matologie/Onkologie, Darmstadt, , Germany
HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-UniversitĂ€t DĂŒsseldorf, Duisburg, , Germany
MVZ DĂŒsseldorf GmbH, Dusseldorf, , Germany
Sana Kliniken DĂŒsseldorf GmbH, DĂŒsseldorf, , Germany
UniversitĂ€tsklinikum DĂŒsseldorf, Klinik fĂŒr HĂ€matologie,Onkologie und Klin. Immunologie, DĂŒsseldorf, , Germany
UniversitÀtsklinik Erlangen, Erlangen, , Germany
St.-Antonius-Hospital Klinik f. HĂ€matologie und Onkologie, Eschweiler, , Germany
UniversitĂ€tsklinikum Essen, Klinik fĂŒr HĂ€matologie, Essen, , Germany
Ev. Krankenhaus Essen-Werden gGmbH, Zentrum fĂŒr Innere Medizin, Klinik fĂŒr HĂ€matologie, Onkologie und Stammzelltransplantation, Essen, , Germany
Centrum fĂŒr HĂ€matologie und Onkologie Bethanien, Frankfurt am Main, , Germany
UniversitÀtsklinikum Frankfurt, Goethe-UniversitÀt Medizinische Klinik II, Frankfurt am Main, , Germany
Agaplesion Markus Krankenhaus, Frankfurt/Main, , Germany
Praxis und Tagesklinik Friedrichshafen, Friedrichshafen, , Germany
Gemeinschaftspraxis Schmitt/Eulenbuch, Gerlingen, , Germany
Justus-Liebig-UniversitĂ€t, Medizinische Klinik IV, GieĂen, , Germany
Kath. Krankenhaus Hagen gGmbH, Abt. HĂ€matologie/Onkologie, Hagen, , Germany
UniversitÀtsklinikum Hamburg-Eppendorf, II - Med. Klinik und Poliklinik, Hamburg, , Germany
Asklepios Klinik Hamburg Altona, II. Med. Klinik, Hamburg, , Germany
Evangelisches Krankhaus Hamm gGmbH, Hamm, , Germany
Onkologische Schwerpunktpraxis, Heidelberg, , Germany
University Hospital Heidelberg, Med. Klinik V, Heidelberg, , Germany
Onkologische Schwerpunktpraxis, Heilbronn, , Germany
SLK Kliniken Heilbronn, Med. Klinik III, Heilbronn, , Germany
UniversitÀtsklinikum des Saarlandes, Innere Medizin I, Homburg, , Germany
Westpfalz-Klinikum GmbH, Kaiserslautern, , Germany
Onkologische Schwerpunktpraxis Karlsruhe, Karlsruhe, , Germany
Onkologische Gemeinschaftspraxis Kassel, Kassel, , Germany
Praxisklinik fĂŒr HĂ€matologie und Onkologie, Koblenz, , Germany
UniversitÀtsklinikum Köln, Klinik I - Innere Medizin, Köln, , Germany
Onkologisches Zentrum, Gemeinschaftspraxis f. HĂ€matologie u. Onkologie im Caritas KH, Lebach, , Germany
Klinikum Lippe GmbH, HĂ€matologie-Onkologie, Lemgo, , Germany
Schwerpunktpraxis fĂŒr HĂ€matologie und Onkologie, Ludwigsburg, , Germany
Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen am Rhein, , Germany
Internistische Schwerpunktpraxis fĂŒr HĂ€matologie und Onkologie, Mainz, , Germany
UniversitÀtsmedizin der Johannes Gutenberg-UniversitÀt Mainz, III. Med. Klinik, Mainz, , Germany
III. Medizinische Klinik HĂ€matologie und Internistische Onkologie, Mannheim, , Germany
Mannheimer Onkologie Praxis, Mannheim, , Germany
Philipps-UniversitÀt Marburg, HÀmatologie/Onkologie/Immunologie, Marburg, , Germany
MĂŒhlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, HĂ€matologie/Onkologie, HĂ€mostaseologie und Palliativmedizin, Minden, , Germany
Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I, Mönchengladbach, , Germany
Praxis fĂŒr HĂ€matologie und internistische Onkologie, Oberhausen, , Germany
Internistisch, Onkologische Gemeinschaftspraxis Dres. BallĂł, Offenbach, , Germany
Onkologische Praxis Oldenburg, Oldenburg, , Germany
Krankenhaus Barmherzige BrĂŒder, Klinik fĂŒr Onkologie und HĂ€matologie, Regensburg, , Germany
Klinikum am Steinenberg, Ermstalklinik, Medizinische Klinik I, Reutlingen, , Germany
Diakonie-Klinikum SchwÀbisch Hall gGmbH, Innere Medizin III, SchwÀbisch Hall, , Germany
ZAHO-Zentrum fĂŒr ambulante HĂ€matologie und Onkologie, Standort Siegburg, Siegburg, , Germany
Diakonie Klinikum Jung-Stilling-Krankenhaus, Medizinische Klinik, Siegen, , Germany
Onkologische Schwerpunktpraxis fĂŒr Onkologie und Gastroenterologie, Singen, , Germany
Onkologische Schwerpunktpraxis Speyer, Speyer, , Germany
Klinikum Mutterhaus der BorromÀerinnen gGmbH, Trier, , Germany
University Hospital TĂŒbingen, Med. Klinik und Poliklinik, Abt. II, TĂŒbingen, , Germany
Schwarzwald-Baar Klinikum, Klinik fĂŒr Innere Medizin II, Villingen-Schwenningen, , Germany
Rems-Murr-Klinikum gGmbH Winnenden, Winnenden, , Germany
Contact Details
Name: Hartmut Goldschmidt, Prof. Dr.
Affiliation: Med. Klinik V, University Hospital Heidelberg
Role: PRINCIPAL_INVESTIGATOR
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