Working group "Statistics for Translational Oncology"
The German-speaking Myeloma-Multicenter Group (GMMG) conducts active research to improve treatment methods for multiple myeloma. Therein our long-term collaboration with the GMMG has witnessed treatment modifications that have been/will be implemented in the German health system. So, the current standard of care for patients with newly diagnosed multiple myeloma includes chemo-combination therapy followed by autologous stem cell transplantation. Based on the analysis of the GMMG-MM5 trial, it was shown that patients aged 65 to 70 years benefit from stem cell transplantation in the same way as the age group <= 65 without additional safety risks [Mai EK, Miah K et al. 2021]. As a consequence, cost absorption of ASCT is now admissible for multiple myeloma patients up to the age of 70 years by statutory health insurances (cf. https://gmmg.info/atp/). In addition, in part 1 of the randomized phase III study GMMG-HD7, it could be shown that the addition of a novel immunotherapy client significantly reduces the risk of detecting residual disease in the bone marrow which is a surrogate for prolongation of progression-free survival. Based on the results of this IIT trial, the monoclonal antibody will be sought for regulatory approval [Goldschmidt et al 2022]. Furthermore, the test for free light chains in the blood has so far been an easy-to-use diagnostic tool for predicting tumor activity. It has now been shown that the normalization of free light chains has a prognostic impact on progression-free survival, allowing an individualized therapy for this subgroup of responding patients. [Klein EM, Tichy D et al., 2021]
The German-Austrian AML Study Group (AMLSG) is one of the world's largest study groups for the research and treatment of AML, initiating a number of innovative national and interventional clinical trials and running the AMLSG BiO Registry Study with around 1,500 newly diagnosed AML patients being recruited annually. All patients included in the AMLSG BiO Registry Study agree to a systematic central biobanking and undergo in-depth molecular and genetic diagnostics which allow for prestigious translational research projects that are published in high-impact journals. Members of the working group have been responsible statisticians in the clinical trials since the study group was founded in 2003 and support many of the accompanying research projects.
In cooperation with the Section of Allogeneic Stem Cell Transplantation at Heidelberg University Hospital we investigate the usefulness of EASIX as prognostic and predictive biomarker for several diseases and endpoints. For instance, we illustrate the prognostic and predictive value of EASIX for time-to-sepsis, the effectiveness of statin-based prophylaxis for non-relapse mortality in different EASIX subgroups and the prognostic value of EASIX for severe complications after CAR-T cell therapy.
- Goldschmidt et al. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Hematology 9(11):e810-821 (2022). doi: 10.1016/S2352-3026(22)00263-0
- Klein EM, Tichy D et al. Prognostic Impact of Serum Free Light Chain Ratio Normalization in Patients with Multiple Myeloma Treated within the GMMG-MM5 Trial. Cancers 13(9): 4856 (2021). DOI: 10.3390/cancers13194856
Mai EK, Miah K. et al. Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age. Leukemia 35(12): 3636 (2021). doi: 10.1038/s41375-021-01357-4.
Publications
- Goldschmidt et al. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Hematology 9(11):e810-821 (2022). doi: 10.1016/S2352-3026(22)00263-0
- Klein EM, Tichy D et al. Prognostic Impact of Serum Free Light Chain Ratio Normalization in Patients with Multiple Myeloma Treated within the GMMG-MM5 Trial. Cancers 13(9): 4856 (2021). DOI: 10.3390/cancers13194856
Mai EK, Miah K. et al. Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age. Leukemia 35(12): 3636 (2021). doi: 10.1038/s41375-021-01357-4.