Spots Global Cancer Trial Database for Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
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Trial Identification
Brief Title: Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
Official Title: A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Study ID: NCT03617731
Conditions
Study Description
Brief Summary: Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide/bortezomib/dexamethasone (RVd) 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: Isatuximab, Lenalidomide 1. Randomization: Patients are randomized in one of 2 study arms (IA or IB) before induction therapy. Patients randomized in arm IA will receive 3 cycles RVd (Bortezomib (VelcadeÂź), Lenalidomide (RevlimidÂź, each cycle is 42 days), Dexamethasone). Patients in arm IB will additionally receive the monoclonal antibody Isatuximab in the 3 cycles RVd. After induction therapy patients undergo intensifying therapy according to GMMG standard (usually mobilization therapy followed by stem cell collection and autologous stem cell transplantation). 2. Randomization: Before maintenance treatment patients are randomized in one of 2 study arms (IIA and IIB): Patients in arm IIA receive Lenalidomide maintenance therapy for three years, patients in arm IIB receive additional Isatuximab. There are two primary objectives: 1. to compare the induction regimen (IA vs IB) regarding minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity at least 1e-5) 2. to compare the maintenance strategies (arms IIA vs IIB) regarding progression-free survival (PFS), defined as time from 2nd randomization (prior to maintenance therapy) to progression or death from any cause whichever occurs first. The duration of the trial for each patients is expected to be 45-48 months (induction and intensification treatment: 6-9 months, 3 months rest between intensification and start of maintenance phase 36 months).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Uniklinik RWTH Aachen, Klinik fĂŒr HĂ€matologie, Onkologie, HĂ€mostaseologie und Stammzelltransplantation, Aachen, , Germany
Studienzentrum Aschaffenburg, Aschaffenburg, , Germany
Helios Klinikum Bad Saarow, Klinik fĂŒr HĂ€matologie, Onkologie und Palliativmedizin, Bad Saarow, , Germany
Charité, Campus Benjamin Franklin , III. Medizinische Abteilung (HÀmatologie/Onkologie), Berlin, , Germany
Vivantes Klinikum Neukölln, Klinik fĂŒr HĂ€matologie und Onkologie, Berlin, , Germany
HELIOS Klinikum, Klinik fĂŒr HĂ€matologie, Onkologie und Immunologie, Berlin, , Germany
Studiengesellschaft Onkologie Bielefeld GbR, Bielefeld, , Germany
Klinikum Bielefeld, Klinik fĂŒr HĂ€matologie, Onkologie und Palliativmedizin, Bielefeld, , Germany
Medizinische UniversitÀtsklinik, Knappschaftskrankenhaus, Bochum, , Germany
UniversitÀtsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, HÀmatologie und Rheumatologie, Bonn, , Germany
Johanniter Krankenhaus Bonn, Bonn, , Germany
Zentrum fĂŒr ambulante HĂ€matologie und Onkologie (ZAHO), Bonn, , Germany
StÀdtisches Klinikum Braunschweig, Med. Klinik III, HÀmatologie und Onkologie, Braunschweig, , Germany
Klinikum Chemnitz GmbH, Innere Medizin III, Chemnitz, , Germany
Carl-Thiem-Klinikum Cottbus gGmbH, II. Medizinische Klinik, Cottbus, , Germany
Onkologisches Studienzentrum Darmstadt, Darmstadt, , Germany
Klinikum Darmstadt, Med. Klinik V, HĂ€matologie/Onkologie, Darmstadt, , Germany
UniversitÀtsklinikum Carl Gustav Carus Dresden, an der Technischen UniversitÀt Dresden, Medizinische Klinik und Poliklinik I, Dresden, , Germany
HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-UniversitĂ€t DĂŒsseldorf, Duisburg, , Germany
Marien Hospital DĂŒsseldorf GmbH, Klinik fĂŒr Onkologie, HĂ€matologie und Palliativmedizin, DĂŒsseldorf, , Germany
UniversitĂ€tsklinikum DĂŒsseldorf, Klinik fĂŒr HĂ€matologie,Onkologie und Klin. Immunologie, DĂŒsseldorf, , Germany
UniversitÀtsklinik Erlangen, Erlangen, , Germany
St. Antonius-Hospital Eschweiler, Klinik fĂŒr HĂ€matologie / 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
Gemeinschaftspraxis Prof. Dr. Michael Kiehl und Dipl. Med. Wolfgang Stein, Frankfurt (Oder), , Germany
Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder), , Germany
Centrum fĂŒr HĂ€matologie und Onkologie Bethanien, Frankfurt am Main, , Germany
Agaplesion Markus Krankenhaus, Med. Klinik I, Frankfurt am Main, , Germany
Krankenhaus Nordwest, Institut fĂŒr Klinisch-Onkologische Forschung, Frankfurt am Main, , Germany
UniversitÀtsklinikum Frankfurt, Goethe-UniversitÀt Medizinische Klinik II, Frankfurt am Main, , Germany
Klinikum Fulda, Klinisches Studienzentrum GmbH, Fulda, , Germany
UniversitĂ€tsklinik der Justus-Liebig-UniversitĂ€t, Medizinische Klinik IV, GieĂen, , Germany
Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch, Klinik fĂŒr HĂ€matologie - Onkologie, Goch, , Germany
Kath. Krankenhaus Hagen gGmbH, Abt. HĂ€matologie/Onkologie, Hagen, , Germany
Asklepios Klinik Hamburg St. Georg, Hamburg, , Germany
UniversitĂ€tsklinikum Hamburg Eppendorf, Zentrum fĂŒr Onkologie, Studienzentrale der II. Medizinischen Klinik, Hamburg, , Germany
Asklepios Klinik Hamburg Altona, II. Med. Klinik, Hamburg, , Germany
Immunologisch-onkologisches MVZ am Siloah Krankenhaus, Hannover, , Germany
KRH Klinikum Siloah, Klinik fĂŒr HĂ€matologie und Onkologie, Hannover, , Germany
Onkologische Schwerpunktpraxis Heidelberg, Heidelberg, , Germany
Krankenhaus St. Vincentius der evangelischen Stadtmission Heidelberg, Abt. HĂ€matologie, Onkologie, Rheumatologie, Heidelberg, , Germany
University Hospital Heidelberg, Med. Klinik V, Heidelberg, , Germany
SLK Kliniken Heilbronn, Med. Klinik III, Heilbronn, , Germany
Marien Hospital Herne, Herne, , Germany
UniversitÀtsklinikum des Saarlandes, Innere Medizin I, Homburg (Saar), , Germany
Westpfalz-Klinikum GmbH, Klinik fĂŒr Innere Medizin I, Kaiserslautern, , Germany
StÀdtisches Klinikum Karlsruhe, Karlsruhe, , Germany
Praxisklinik fĂŒr HĂ€matologie und Onkologie, Koblenz, , Germany
Uniklinik Köln, Klinik I fĂŒr Innere Medizin, Köln, , Germany
Gemeinschaftspraxis fĂŒr HĂ€matologie und Onkologie am Caritas Krankenhaus, Lebach, , Germany
UniversitÀtsklinikum Leipzig AöR, Medizinische Klinik und Poliklinik I-HÀmatologie und Zelltherapie, Internistische Onkologie, HÀmostaseologie, Leipzig, , Germany
Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen am Rhein, , 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
UniversitĂ€tsklinikum MĂŒnster, Med. Klinik A, MĂŒnster, , Germany
Klinikum OsnabrĂŒck GmbH, OsnabrĂŒck, , Germany
BrĂŒderkrankenhaus St. Josef Paderborn, Klinik fĂŒr HĂ€matologie und Onkologie, Paderborn, , Germany
Krankenhaus Barmherzige BrĂŒder, Klinik fĂŒr Onkologie und HĂ€matologie, Regensburg, , Germany
Gemeinschaftspraxis fĂŒr HĂ€matologie und Onkologie, Onkologisches Zentrum, Saarlouis, , Germany
Diakonie-Klinikum SchwÀbisch Hall gGmbH, Innere Medizin III, SchwÀbisch Hall, , Germany
ZAHO-Zentrum fĂŒr ambulante HĂ€matologie und Onkologie, Standort Siegburg, Siegburg, , Germany
Onkologische Schwerpunktpraxis Speyer, Speyer, , Germany
Klinikum Stuttgart, Stuttgart Cancer Center, Tumorzentrum Eva Mayr-Stihl, Stuttgart, , Germany
Klinikum Mutterhaus der BorromÀerinnen gGmbH, Trier, , Germany
University Hospital TĂŒbingen, Med. Klinik und Poliklinik, Abt. II, TĂŒbingen, , Germany
Bundeswehrkrankenhaus Ulm, Abteilung Innere Medizin - HĂ€matologie und internistische Onkologie, Ulm, , Germany
Schwarzwald-Baar Klinikum, Innere Medizin II, Villingen-Schwenningen, , Germany
Rems-Murr-Kliniken gGmbH, Winnenden, , Germany
Contact Details
Name: Hartmut Goldschmidt, Prof. Dr.
Affiliation: Med. Klinik V, University Hospital Heidelberg
Role: PRINCIPAL_INVESTIGATOR
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