Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
999 participants
OBSERVATIONAL
2022-12-08
2027-03-31
Brief Summary
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Overall survival, progression-free survival and follow-up time.
The relevant registry data will be provided and evaluated together with the therapy study data for scientific research projects.
This allows seamless documentation of patient data from the end of the trial to long-term follow-up.
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Detailed Description
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The Myeloma Registry was activated on December 8, 2022. Currently 35 GMMG centers in Germany are participating. The first longtime follow-up data set included in the registry was the GMMG-HD 6 trial. The GMMG-HD6 trial is a phase 3 trial which investigated the efficacy of the addition of the anti-SLAMF7 monoclonal antibody, elotuzumab, to the standard induction and consolidation therapy consisting of lenalidomide, bortezomib and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma.
Target variables of interest are progression-free survival (PFS) from randomization, overall survival (OS), the follow-up time, the cause of death and the therapy free time after first relapse and its treatment. Further objectives will be defined and analyzed for each evaluation.
Participations will be observed while the patient is being treated with standard of care until death, lost to follow-up or consent withdrawn. Follow-ups will be documented every six months until the 1st Progression Disease and then annually. The pseudonymized clinical data is stored in a separate database (eCRF) and is monitored centrally on a regular basis. The eCRF contain automated plausibility checks, so called queries.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patient with multiple myeloma
newly- diagnosed, transplant eligible multiple myeloma patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Dietmar Hopp Stiftung
OTHER
KKS Netzwerk
NETWORK
German Cancer Research Center
OTHER
Prof. Dr. Hartmut Goldschmidt
OTHER
Responsible Party
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Prof. Dr. Hartmut Goldschmidt
Head of GMMG- study group
Principal Investigators
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Hartmut Goldschmidt, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg
Locations
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HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie
Berlin, , Germany
Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie)
Berlin, , Germany
Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin
Bielefeld, , Germany
Medizinische Universitätsklinik, Knappschaftskrankenhaus
Bochum, , Germany
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie
Bonn, , Germany
Klinikum Chemnitz GmbH, Innere Medizin III
Chemnitz, , Germany
Universitätsklinikum Köln, Klinik I - Innere Medizin
Cologne, , Germany
Onkologisches Studienzentrum Darmstadt
Darmstadt, , Germany
Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie
Darmstadt, , Germany
Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie
Düsseldorf, , Germany
Universitätsklinik Erlangen
Erlangen, , Germany
Universitätsklinikum Essen, Klinik für Hämatologie und Stammzelltransplantation
Essen, , Germany
Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation
Essen, , Germany
Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II
Frankfurt am Main, , Germany
Justus-Liebig-Universität, Medizinische Klinik IV
Giessen, , Germany
Kath. Krankenhaus Hagen GmbH, Abt. Hämatologie/Onkologie
Hagen, , Germany
Asklepios Klinik Hamburg Altona, II. Med. Klinik
Hamburg, , Germany
Onkologische Schwerpunktpraxis
Heidelberg, , Germany
University Hospital Heidelberg, Med. Klinik V
Heidelberg, , Germany
SLK Kliniken Heilbronn, Med. Klinik III
Heilbronn, , Germany
Universitätsklinikum des Saarlandes, Innere Medizin I
Homburg, , Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, , Germany
Praxisklinik für Hämatologie und Onkologie
Koblenz, , Germany
Onkologisches Zentrum, Gemeinschaftspraxis f. Hämatologie u. Onkologie im Caritas KH
Lebach, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik
Mainz, , Germany
III. Medizinische Klinik Hämatologie und Internistische Onkologie
Mannheim, , Germany
Mannheimer Onkologie Praxis
Mannheim, , Germany
Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie
Marburg, , Germany
Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I
Mönchengladbach, , Germany
Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie
Regensburg, , Germany
Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III
Schwäbisch Hall, , Germany
ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg
Siegburg, , Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, , Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, , Germany
University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DRKS00026970
Identifier Type: REGISTRY
Identifier Source: secondary_id
GMMG Myeloma Registry
Identifier Type: -
Identifier Source: org_study_id
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