Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma
| العنوان: | Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized 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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| المؤلفون: | Igor Wolfgang Blau, Katja Weisel, Jan Duerig, Mathias Haenel, Roland Fenk, Uta Bertsch, Christina Kunz, Stefanie Huhn, Marc S. Raab, Hartmut Goldschmidt, Uwe M. Martens, Ullrich Graeven, Manfred Hensel, Stefan Fronhoffs, Jens Hillengass, Mohammed Wattad, Hans Salwender, Markus Munder, Anna Jauch, Hans-Walter Lindemann, Timon Hansen, Dirk Hose, Christof Scheid, Axel Benner, Mindaugas Andrulis, Michael Hundemer, Andrea Seidel-Glaetzer |
| المساهمون: | Hematology, Basic (bio-) Medical Sciences |
| المصدر: | BMC Cancer BMC Cancer, Vol 19, Iss 1, Pp 1-11 (2019) |
| بيانات النشر: | BioMed Central, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | 0301 basic medicine, Oncology, Male, Cancer Research, medicine.medical_treatment, Medizin, Dexamethasone, Bortezomib, Study Protocol, 610 Medical sciences Medicine, 0302 clinical medicine, Autologous stem-cell transplantation, Multiple myeloma, Clinical endpoint, Lenalidomide/administration & dosage, Prospective Studies, Elotuzumab, Lenalidomide, Melphalan, hematology, Hematopoietic Stem Cell Transplantation, Induction Chemotherapy, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, elotuzumab, Multiple Myeloma/therapy, Treatment Outcome, Research Design, 030220 oncology & carcinogenesis, Female, autologous stem cell transplant, Antibodies, Monoclonal, Humanized/administration & dosage, medicine.drug, Dexamethasone/administration & dosage, Adult, Melphalan/administration & dosage, medicine.medical_specialty, Antibodies, Monoclonal, Humanized, lcsh:RC254-282, Maintenance Chemotherapy, 03 medical and health sciences, Young Adult, Internal medicine, Genetics, medicine, Humans, Aged, Chemotherapy, business.industry, medicine.disease, Survival Analysis, Consolidation Chemotherapy, 030104 developmental biology, Quality of Life, Bortezomib/administration & dosage, business, high-dose chemotherapy |
| الوصف: | Background: Despite major advances in therapy, multiple myeloma is still an incurable malignancy in the majority of patients. To increase survival, deeper remissions (i.e. CR) translating into longer PFS need to be achieved. Incorporation of new drugs (i.e. bortezomib and lenalidomide) as induction and maintenance treatment in an intensified treatment concept, including high dose melphalan (200 mg/m2), has resulted in increased CR rates, and is considered the standard of care for younger patients. Elotuzumab in combination with lenalidomide and dexamethasone has given better results as lenalidomide and dexamethasone alone in a phase III trial. The GMMG-HD6 trial will be the first phase III trial investigating the role of elotuzumab in combination with bortezomib, lenalidomide and dexamethasone (VRD) induction/consolidation and lenalidomide maintenance within a high dose concept. Methods: GMMG-HD6 is a randomized, open, multicenter phase III trial. The planned recruitment number is 564 NDMM patients. All patients will receive 4 VRD cycles as induction and undergo peripheral blood stem cell mobilization and harvesting. Thereafter they will be treated with high dose melphalan therapy plus autologous stem cell transplantation followed by 2 cycles of VRD consolidation and lenalidomide maintenance. Patients in arm B1 + B2 will additionally receive elotuzumab in the induction phase, whereas patients in A2 + B2 will be treated with elotuzumab added to consolidation and maintenance. The primary endpoint of the trial is PFS. Secondary objectives and endpoints are OS, CR rates after induction therapy comparing the two arms VRD (A1 + A2) vs VRD + elotuzumab (B1 + B2), CR rates after consolidation treatment, best response to treatment during the study, time to progression (TTP), duration of response (DOR), toxicity and quality of life. Results: Since this is the publication of a study protocol of an ongoing study, no results can be presented. Discussion: This phase III trial is designed to evaluate whether the addition of elotuzumab to an intensified treatment concept with high dose melphalan chemotherapy plus autologous stem cell transplantation and induction, consolidation and maintenance treatment with bortezomib and lenalidomide is able to improve PFS compared to the same concept without elotuzumab. Trial registration: NCT02495922 on June 24th, 2015. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1471-2407 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::18b58d1361d94b3c6f22e13502a6ffd2Test http://europepmc.org/articles/PMC6537200Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....18b58d1361d94b3c6f22e13502a6ffd2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14712407 |
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