The GMMG-HD5 trial: bortezomib-based induction prior to high dose therapy and autologous stem cell transplantation followed by lenalidomide-based consolidation and maintenance therapy in patients with multiple myeloma

2012 ◽  
Author(s):  
Hartmut Goldschmidt
2017 ◽  
Vol 70 (suppl. 1) ◽  
pp. 51-55
Author(s):  
Jelena Bila ◽  
Jelena Jelicic ◽  
Milena Todorovic-Balint ◽  
Darko Antic ◽  
Dragana Vujic ◽  
...  

Introduction. Limited efficacy of standard chemotherapy initiated the introduction of high-dose therapy followed by autologous stem cell transplantation in the treatment of patients with multiple myeloma. The aim of the study was to analyse results of treatment with high-dose therapy followed by autologous stem cell transplantation in 110 newly diagnosed multiple myeloma patients during the period May 2015 - January 2016. Material and Methods. Patient group consisted of 51 female and 59 male patients with average age of 57 years. Most of the patients were diagnosed with IgG myeloma (58.2%) and clinical stage III (74.5%, Salmon&Durie). Renal impairment initially existed in 26 patients. By 2008, patients were treated with 4-6 cycles of induction chemotherapy according to the protocol VAD (33 patients, 30%); and afterward according to the CTD protocol (72 patients, 65.5%). Mobilization of the stem cell was performed according to the protocol CAD followed by granulocyte colony-stimulating factor 5-10 ?g/kg body weight/day starting on day 9, until the apheresis around day 14 of mobilization (? 1-2 days). Within 4-8 weeks after mobilization, HDT with Melphalan 200 mg/m2 accompanied with autologous stem cell transplantation was performed. Results. Applied induction treatment resulted in the achievement of at least partial remission in 80% patients. The average number of CD34+ in the product of apheresis was 8.1x106/kgBW, while during HDT with autologous stem cell transplantation, median was 4x106/kg body weight CD34+ cells. Average recovery was registered around +15 days after autologous stem cell transplantation, characterized by a minimal number of febrile days (median 2 days, range 0-10 days). In 95% patients, partial remission was recorded +100 days after autologous stem cell transplantation with average duration of 45 months, and achievement of complete remission in 29% pts with median overall survival of 100 months. This treatment approach resulted in overall survival longer than 45 months in more than 90% patients. The factors found to affect the duration of remission and overall survival are: ISS score ?2. Conclusion. High-dose therapy followed by autologous stem cell transplantation is an efficient and safe treatment approach to multiple myeloma patients. Along with biological characteristics of the disease, complete remission achievement after such treatment is of essential significance for the course and outcome of multiple myeloma patients.


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