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Spots Global Cancer Trial Database for Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

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Trial Identification

Brief Title: Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

Official Title: A Randomized Phase III Non-inferiority Trial Assessing Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Transplant-eligible Patients With Newly Diagnosed Multiple Myeloma.

Study ID: NCT05804032

Study Description

Brief Summary: The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.

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 Product: Isatuximab, subcutaneous administration via a wearable injector system. Randomization: Patients are randomized in one of 2 study arms (A or B) before induction therapy. Patients randomized in arm A will receive 3 cycles of the monoclonal antibody isatuximab intravenously, combined with RVd regimen (Lenalidomide, Bortezomib, Dexamethasone). Each cycle will last for 42 days. Patients in arm B will receive 3 cycles RVd plus isatuximab subcutaneously. After induction therapy, patients will receive standard intensification (usually cyclophosphamide-based mobilization therapy, stem cell collection and high-dose melphalan followed by autologous stem cell transplantation (HDM/ASCT)). End of study will be after the first HDM/ASCT. There is one primary objective: Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd, with respect to rates of VGPR or better after induction therapy (according to standard International Myeloma Working Group (IMWG) response criteria). Key secondary objectives are: 1. Comparison of patient-reported outcomes (PRO) regarding route of administration of isatuximab (SC vs. IV) on induction therapy as assessed by modified CTSQ (modified 9-item questionnaire). 2. Non-inferiority of rates of MRD negativity (assessed by NGS from BMA; sensitivity 10\^-5) independent of standard IMWG response after induction therapy. The duration of the trial for each patients is expected to be approximately 10 months (induction and intensification treatment).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UniversitÀtsklinikum Krems, Krems, , Austria

Ordensklinikum Linz, Linz, , Austria

Landeskrankenhaus Feldkirch-Rankweil, Rankweil, , Austria

UniversitÀtsklinikum der Paracelsus, 3. Med. Abteilung/Onkologie Ambulanz, Salzburg, , Austria

UniversitÀtsklinikum St. Pölten - Lilienfeld, St. Pölten, , Austria

Phyrn-Eisenwurzen Klinikum Steyr, Steyr, , Austria

Uniklinik RWTH Aachen, Klinik fĂŒr HĂ€matologie, Onkologie, HĂ€mostaseologie und Stammzelltransplantation, Aachen, , Germany

Klinikum Augsburg, II. Medizinische Klinik HĂ€matologie/Onkologie, Augsburg, , Germany

Helios Klinikum Bad Saarow, Klinik fĂŒr HĂ€matologie, Onkologie und Palliativmedizin, Bad Saarow, , Germany

MedZentrum Klinikum Bayreuth GmbH, Bayreuth, , Germany

Charité, III. Medizinische Abteilung (HÀmatologie/Onkologie), Berlin, , Germany

Vivantes Klinikum Neukölln, Klinik fĂŒr HĂ€matologie und Onkologie, Berlin, , Germany

Klinik fĂŒr HĂ€matologie und Stammzelltransplantation, Helios Klinikum Berlin-Buch, Berlin, , Germany

Vivantes Klinikum Spandau, Berlin, , Germany

Bielefeld Praxis, Studiengesellschaft Onkologie, Bielefeld, , Germany

Evangelisches Klinikum Bethel, Bielefeld, , Germany

Johanniter-Krankenhaus Bonn, Bonn, , Germany

UniversitÀtsklinikum Bonn, Medizinische Klinik III, Bonn, , Germany

StÀdtisches Klinikum Braunschweig, Braunschweig, , Germany

Klinikum Bremen-Mitte, Bremen, , Germany

Klinikum Chemnitz gGmbH, Chemnitz, , Germany

Carl-Thiem-Klinikum Cottbus gGmbH, 2. Medizinische Klinik, Cottbus, , Germany

Klinikum Darmstadt, Medizinische Klinik V HĂ€matologie/Onkologie, Darmstadt, , Germany

St.-Johannes-Hospital, Dortmund, , Germany

UniversitÀtsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I, Dresden, , Germany

Helios St. Johannes Klinik Duisburg, Medizinische Klinik 2, Duisburg, , Germany

UniversitĂ€tsklinikum DĂŒsseldorf, Klinik fĂŒr HĂ€matologie, Onkologie und Klinische Immunologie, DĂŒsseldorf, , Germany

Marien Hospital DĂŒsseldorf GmbH, Klinik fĂŒr Onkologie, HĂ€matalogie und Palliativmedizin, DĂŒsseldorf, , Germany

St. Antonius-Hospital Eschweiler, Klinik fĂŒr HĂ€matologie / Onkologie, Eschweiler, , Germany

UniversitÀtsklinikum Essen, Essen, , Germany

KEM I Evang. Kliniken Essen-Mitte gGmbH, Evangelisches Krankenhaus Essen-Werden gGmbH, Klinik fĂŒr HĂ€matologie, Onkologie und Stammzelltransplantation, Essen, , Germany

Malteser Krankenhaus, St. Franziskus Hospital, HĂ€matologie/Onkologie, Flensburg, , Germany

Centrum fĂŒr HĂ€matologie und Onkologie Bethanien, Frankfurt am Main, , Germany

UniversitÀtsklinikum Frankfurt, Medizinische Klinik 2, HÀmatologie/Onkologie, Frankfurt am Main, , Germany

UniversitÀtsklinikum Freiburg, Freiburg, , Germany

UniversitĂ€tsmedizin Greifswald, Klinik und Poliklinik fĂŒr Innere Medizin C, Greifswald, , Germany

UniversitÀtsklinikum Göttingen, Göttingen, , Germany

Katholisches Krankenhaus Hagen gGmbH, Klinik fĂŒr HĂ€matologie und Onkologie, Hagen, , Germany

UniversitÀtsklinikum Halle, Halle, , Germany

Asklepios Kliniken Hamburg GmbH, Hamburg-Altona, , Germany

UniversitĂ€tsklinikum Hamburg-Eppendorf, Zentrum fĂŒr Onkologie, Hamburg, , Germany

Onkologische Schwerpunktpraxis Heidelberg, Heidelberg, , Germany

UniversitÀtsklinikum Heidelberg, Medizinische Klinik V, Heidelberg, , Germany

SLK Kliniken Heilbronn, Medizinische Klinik III, Heilbronn, , Germany

UniversitĂ€tsklinikum des Saarlandes, Klinik fĂŒr Innere Medizin 1, Homburg, , Germany

Klinikum der Friedrich-Schiller-UniversitĂ€t Jena, Klinik fĂŒr Innere Medizin II, Abteilung HĂ€matologie und internistische Onkologie, Jena, , Germany

Westpfalz-Klinikum, Kaiserslautern, , Germany

StÀdtisches Klinikum Karlsruhe, Karlsruhe, , Germany

Klinikverbund AllgÀu, Klinikum Kempten, HÀmatologie / Onkologie, Kempten, , Germany

UniversitÀtsklinikum Schleswig-Holstein, Campus Kiel, Kiel, , Germany

Gemeinschaftsklinikum Mittelrhein, Koblenz, , Germany

UniversitÀtsklinikum Köln, Köln, , Germany

Gemeinschaftspraxis fĂŒr HĂ€matologie und Onkologie, Lebach, , Germany

UniversitÀtsklinikum Leipzig, Leipzig, , Germany

Klinikum der Stadt Ludwigshafen, Ludwigshafen, , Germany

UniversitĂ€tsklinikum Schleswig-Holstein, Campus LĂŒbeck, LĂŒbeck, , Germany

UniversitÀtsklinikum Magdeburg, Magdeburg, , Germany

UniversitÀtsmedizin der Johannes Gutenberg-UniversitÀt Mainz, III. Medizinische Klinik und Poliklinik, Mainz, , Germany

Mannheimer Onkologie Praxis, Mannheim, , Germany

UniversitÀtsklinikum Mannheim, III. Medizinische Klinik, Mannheim, , Germany

Philipps-UniversitĂ€t Marburg, Abteilung HĂ€matologie, Onkologie und Immunologie am UniversitĂ€tsklinikum Gießen und Marburg GmbH, Marburg, , Germany

Klinikum Hochsauerland, Meschede, , Germany

Kliniken Ostalb - Standort Stauferklinikum, HĂ€matologie und Onkologie, Mutlangen, , Germany

Kliniken Maria Hilf GmbH, Medizinische Klinik I, Mönchengladbach, , Germany

Rotkreuzklinikum, MĂŒnchen, , Germany

Klinikum rechts der Isar der Technischen UniversitĂ€t MĂŒnchen, Klinik und Poliklinik fĂŒr Innere Medizin III, HĂ€matologie und Onkologie, MĂŒnchen, , Germany

UniversitĂ€tsklinikum MĂŒnster, 1. Medizinische Klinik A, MĂŒnster, , Germany

Klinik Oldenburg, Oldenburg, , Germany

Klinikum OsnabrĂŒck, OsnabrĂŒck, , Germany

BrĂŒderkrankenhaus St. Josef, Paderborn, , Germany

Krankenhaus Barmherzige BrĂŒder Regensburg, Klinik fĂŒr Onkologie und HĂ€matologie, Regensburg, , Germany

UniversitÀtsklinikum Regensburg, Regensburg, , Germany

Diakonie-Klinikum SchwÀbisch Hall gGmbH, Innere Medizin III (Tumorerkrankungen, Palliativmedizin), SchwÀbisch Hall, , Germany

ZAHO-Zentrum fĂŒr ambulante HĂ€matologie und Onkologie, Siegburg, , Germany

Zentrum fĂŒr ambulante HĂ€matologie und Onkologie (ZAHO), Siegburg, , Germany

Onkologische Schwerpunktpraxis Speyer, Speyer, , Germany

Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital, Stuttgart, , Germany

Robert-Bosch-Krankenhaus, Stuttgart, , Germany

UniversitĂ€t TĂŒbingen, Medizinische UniversitĂ€tsklinik, Innere Medizin II: Onkologie, HĂ€matologie, Klinische Immunologie und Rheumatologie, TĂŒbingen, , Germany

UniversitÀtsklinikum Ulm, Ulm, , Germany

University of WĂŒrzburg, Med. Klinik und Poliklinik II, WĂŒrzburg, , Germany

Contact Details

Name: Hartmut Goldschmidt, Prof.

Affiliation: GMMG study group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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