626 results on '"Salwender, Hans"'
Search Results
202. Catheter-related infection and thrombosis of the internal jugular vein in hematologic-oncologic patients undergoing chemotherapy
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Harter, Christoph, primary, Salwender, Hans J�rgen, additional, Bach, Alfons, additional, Egerer, Gerlinde, additional, Goldschmidt, Hartmut, additional, and Ho, Anthony D., additional
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- 2001
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203. Efficacy of continuous infusion of ceftazidime for patients with neutropenic fever after high-dose chemotherapy and peripheral blood stem cell transplantation
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Egerer, Gerlinde, primary, Goldschmidt, Hartmut, additional, Salwender, Hans, additional, Hegenbart, Ute, additional, Ehrhard, Ingrid, additional, Haas, Rainer, additional, and Ho, Anthony D, additional
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- 2000
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204. Increased Risk of Catheter Colonization and Catheter-Related Infections in Severe Immunocompromized Patients with Multiple Myeloma Undergoing High-dose Glucocorticoid Treatment
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Goldschmidt, Hartmut, primary, Salwender, Hans-Jürgen, additional, Hahn, Uwe, additional, Hegenbart, Ute, additional, Egerer, Gerline, additional, Wallmeier, Martin, additional, Jansen, Bernd, additional, and Haas, Rainer, additional
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- 1998
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205. Comparison of oral itasetron with oral ondansetron
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Goldschmidt, Hartmut, primary, Salwender, Hans, additional, Egerer, Gerlinde, additional, Kempe, Rudolf, additional, and Voigt, Thor, additional
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- 1997
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206. Prevention of Catheter-related Infections by Silver Coated Central Venous Catheters in Oncological Patients
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Goldschmidt, Hartmut, primary, Hahn, Uwe, additional, Salwender, Hans-Jürgen, additional, Haas, Rainer, additional, Jansen, Bernd, additional, Wolbring, Peter, additional, Rinck, Michael, additional, and Hunstein, Werner, additional
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- 1995
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207. Large-bore central venous catheters for the collection of peripheral blood stem cells
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Hahn, Uwe, primary, Goldschmidt, Hartmut, additional, Salwender, Hans, additional, Haas, Rainer, additional, and Hunstein, Werner, additional
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- 1995
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208. Antimicrobial therapy of febrile complications after high-dose chemotherapy and autologous hematopoietic stem cell transplantation-guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO).
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Weissinger, Florian, Auner, Holger, Bertz, Hartmut, Buchheidt, Dieter, Cornely, Oliver, Egerer, Gerlinde, Heinz, Werner, Karthaus, Meinolf, Kiehl, Michael, Krüger, William, Penack, Olaf, Reuter, Stefan, Ruhnke, Markus, Sandherr, Michael, Salwender, Hans-Jürgen, Ullmann, Andrew, Waldschmidt, Dirk, and Wolf, Hans
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ANTI-infective agents ,DENTAL prophylaxis ,FEBRILE seizures ,DRUG therapy ,HEMATOPOIETIC stem cell transplantation ,ONCOLOGY ,HEMATOLOGY - Abstract
More than 18,000 autolgous transplantation were performed in Europe in the year 2009. It as a routine procedure in experienced centres. Even if there is a low mortality rate, infections are a major issue after transplantation, occurring in more than 60 % of the patients. In this review we discuss all aspects of infections after autologous stem transplantation, including epidemiology, diagnostics, therapeutic algorithms, prophylaxis and supportive therapy. [ABSTRACT FROM AUTHOR]
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- 2012
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209. Treatment with Thalidomide and Cyclophosphamide (TCID) is Superior to Vincristine (VID) and to Vinorelbine (VRID) Regimens in Patients with Refractory or Recurrent Multiple Myeloma.
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Auel, Britta, Goldschmidt, Hartmut, Geer, Thomas, Moehler, Thomas, Platzbecker, Uwe, Naumann, Ralph, Blau, Igor, Hänel, Mathias, Knauf, Wolfgang, Nückel, Holger, Salwender, Hans-Jürgen, Scheid, Christof, Weisel, Katja, Gorschlüter, Marcus, Glasmacher, Axel, and Schmidt-Wolf, Ingo
- Abstract
Treatment of relapsed or refractory multiple myeloma remains a challenge and novel treatment regimen are required. Here, a matched pair analysis was performed comparing TCID (thalidomide, cyclophosphamide, idarubicin, dexamethasone) treatment to the treatment of patients with VID (vincristine, idarubicin, dexamethasone) or with VRID (vinorelbine, idarubicin, dexamethasone) for relapsed or refractory multiple myeloma. In total, 197 patients were enrolled in multicenter trials. After matching for important prognostic variables 46 matched-pairs (total of 138 patients) could be analysed with regard to survival, toxicity and efficacy. Interestingly, a significant improvement of overall response rate (ORR) for TCID treatment compared to VID and VRID was found. In addition, TCID treatment also led to a significantly higher overall survival (OS) as well as progression-free survival (PFS) compared to VID and VRID. In conclusion, TCID treatment appears to be superior to VRID and VID treatment in patients with progressive or refractory myeloma. [ABSTRACT FROM AUTHOR]
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- 2012
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210. Central venous catheter-related infections in hematology and oncology.
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Wolf, Hans-Heinrich, Leithäuser, Malte, Maschmeyer, Georg, Salwender, Hans, Klein, Ulrike, Chaberny, Iris, Weissinger, Florian, Buchheidt, Dieter, Ruhnke, Markus, Egerer, Gerlinde, Cornely, Oliver, Fätkenheuer, Gerd, and Mousset, Sabine
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INFECTION ,DIAGNOSIS ,CATHETERS ,DRUG delivery devices ,GRAM-positive bacteria ,ANTI-infective agents - Abstract
Catheter-related infections (CRI) cause considerable morbidity in hospitalized patients. The incidence does not seem to be higher in neutropenic patients than in nonneutropenic patients. Gram-positive bacteria (coagulase-negative staphylococci, Staphylococcus aureus) are the pathogens most frequently cultured, followed by Candida species. Positive blood cultures are the cornerstone in the diagnosis of CRIs, while local signs of infection are not necessarily present. Blood cultures should be taken from peripheral blood and from the venous catheter. A shorter time to positivity of catheter blood cultures as compared with peripheral blood cultures supports the diagnosis of a CRI. In many cases, a definite diagnosis requires catheter removal and microbiological analysis. The role plate method with semiquantitative cultures has been established as standard in most laboratories. Antimicrobial treatment of CRI should be directed by the in vitro susceptibility of the isolated pathogen. Primary removal of the catheter is mandatory in S. aureus and Candida infections, as well as in case of tunnel or pocket infections. Future studies will elucidate whether the rate of CRI in neutropenic patients may be reduced by catheters impregnated with antimicrobial agents. [ABSTRACT FROM AUTHOR]
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- 2008
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211. Prognostic Impact of Serum Free Light Chain Ratio Normalization in Patients with Multiple Myeloma Treated within the GMMG-MM5 Trial.
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Klein, Eva-Maria, Tichy, Diana, Salwender, Hans J., Mai, Elias K., Duerig, Jan, Weisel, Katja C., Benner, Axel, Bertsch, Uta, Akhavanpoor, Mabast, Besemer, Britta, Munder, Markus, Lindemann, Hans-Walter, Hose, Dirk, Seckinger, Anja, Luntz, Steffen, Jauch, Anna, Elmaagacli, Ahmet, Fuhrmann, Stephan, Brossart, Peter, and Goerner, Martin
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MULTIPLE myeloma treatment ,IMMUNOGLOBULINS ,CONFIDENCE intervals ,MULTIPLE regression analysis ,IMMUNE system ,HEALING ,CANCER patients ,SURVIVAL analysis (Biometry) ,DESCRIPTIVE statistics ,MULTIPLE myeloma ,TUMOR markers ,HEMATOPOIETIC stem cell transplantation ,PROPORTIONAL hazards models - Abstract
Simple Summary: For multiple myeloma (MM) patients with measurable disease, there is no recommendation to monitor serum free light chains during therapy. However, this could provide important information in terms of prognosis. We investigated the prognostic impact of serum free light chain ratio (FLCr) normalization in 590 patients with secretory MM during first-line treatment within the German-Speaking Myeloma Multicenter Group MM5 trial. We are able to show that there is an increasing percentage of patients who achieve FLCr normalization during therapy. Importantly, we demonstrate that FLCr normalization at any time before the start of maintenance is significantly associated with prolonged progression-free and overall survival in multivariable time-dependent Cox regression analyses. This suggests that FLCr normalization during therapy is an important and simple way to assess prognostic factor in MM and supports the serial measurement of serum free light chains during therapy, even in patients with secretory MM. We investigated the prognostic impact of time-dependent serum free light chain ratio (FLCr) normalization in 590 patients with secretory multiple myeloma (MM) during first-line treatment within the German-Speaking Myeloma Multicenter Group MM5 trial. Serum free light chains (sFLC) were assessed by the Freelite test at baseline, after induction, mobilization, autologous blood stem cell transplantation, consolidation and every three months during maintenance or follow up within two years after the start of maintenance. The proportion of patients with a normal or normalized FLCr increased from 3.6% at baseline to 23.2% after induction and 64.7% after consolidation. The achievement of FLCr normalization at any one time before the start of maintenance was associated with significantly prolonged progression-free survival (PFS) (p < 0.01, hazard ratio (HR) = 0.61, 95% confidence interval (95% CI) = 0.47–0.79) and overall survival (OS) (p = 0.02, HR = 0.67, 95% CI = 0.48–0.93) in multivariable time-dependent Cox regression analyses. Furthermore, reaching immune reconstitution, defined as the normalization of uninvolved immunoglobulins, before maintenance was associated with superior PFS (p = 0.04, HR = 0.77, 95% CI = 0.60–0.99) and OS (p = 0.01, HR = 0.59, 95% CI = 0.41–0.86). We conclude that FLCr normalization during therapy is an important favorable prognostic factor in MM. Therefore, we recommend serial measurements of sFLC during therapy until achieving FLCr normalization, even in patients with secretory MM. [ABSTRACT FROM AUTHOR]
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- 2021
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212. Bortezomib in combination with intermediate-dose dexamethasone and continuous low-dose oral cyclophosphamide for relapsed multiple myeloma.
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Kropff, Martin, Bisping, Guido, Schuck, Elke, Liebisch, Peter, Lang, Nicola, Hentrich, Markus, Dechow, Tobias, Kröger, Nicolaus, Salwender, Hans, Metzner, Bernd, Sezer, Orhan, Engelhardt, Monika, Wolf, Hans-Heinrich, Einsele, Hermann, Volpert, Sarah, Heinecke, Achim, Berdel, Wolfgang E., and Kienast, Joachim
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CLINICAL trials ,ANTINEOPLASTIC agents ,ORAL drug administration ,CANCER chemotherapy ,MULTIPLE myeloma ,PATIENTS - Abstract
A phase 2 trial was performed to study the combination of bortezomib (VELCADE®) with intermediate-dose dexamethasone (DEX), and continuous low-dose oral cyclophosphamide (CY) in patients with relapsed multiple myeloma (MM). Fifty-four patients with advanced MM were enroled to receive eight 3-week treatment cycles with bortezomib 1·3 mg/m
2 on days 1, 4, 8, and 11, followed by three 5-week cycles with bortezomib 1·3 mg/m2 on days 1, 8, 15, and 22. Within all cycles, DEX 20 mg/d was given orally on the day of bortezomib injection and the day thereafter. In addition, patients received CY continuous oral treatment at a dose of 50 mg/d p.o. once daily. Fifty patients completing at least one treatment cycle were evaluable for response. Complete, partial, and minor responses occurred in 16%, 66% and 8% of patients, respectively; overall response rate 90% (efficacy analysis). Median event-free survival was 12 months, with a median overall survival of 22 months. Adverse events (AE) of grades 3 or 4 occurring in at least 10% of patients comprised leucopenia, infection, herpes zoster, thrombocytopenia, neuropathy and fatigue. Bortezomib combined with DEX and CY is a highly effective treatment for relapsed MM at an acceptable rate of grade 3/4 AE. Antiviral prophylaxis appears to be mandatory. [ABSTRACT FROM AUTHOR]- Published
- 2007
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213. Chlorhexidine and silver-sulfadiazine coated central venous catheters in haematological patients--a double-blind, randomised, prospective, controlled trial.
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Ostendorf, Torben, Meinhold, Andrea, Harter, Christoph, Salwender, Hans, Egerer, Gerlinde, Geiss, Heinrich K, Ho, Antony D, and Goldschmidt, Hartmut
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CENTRAL venous catheterization ,CHLORHEXIDINE ,PREVENTION of communicable diseases ,COMPARATIVE studies ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,SILVER sulfadiazine ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,HEMATOLOGIC malignancies ,EQUIPMENT & supplies - Abstract
Background: Central venous catheters (CVCs) are essential for the intensive care of patients with haematological illness. Catheter-related infections (CRI) are an important problem in modern medicine, which may lead to life-threatening situations, to prolonged hospitalisation and increased cost. In immunocompromised patients suffering from haemato-oncological diseases, CRI is a significant factor for adverse outcome. Several clinical studies have shown that CVCs coated with antiseptics such as chlorhexidine and silver-sulfadiazine (CHSS) reduce the risk of catheter-related bacteraemia. Most studies, however, were performed on intensive care patients not suffering from chemotherapy-induced immunosuppression.Patients and Methods: A prospective double-blind, randomised, controlled trial was performed to investigate the effectiveness of CHSS-coated catheters in haemato-oncological patients. A total number of 184 catheters (median duration of placement, 11 days) were inserted into 184 patients (male 115, female 69), of which 90 were antiseptically coated. After removal, all catheters were investigated for bacterial growth.Main Results: Catheters coated with CHSS were effective in reducing the rate of significant bacterial growth on either the tip or subcutaneous segment (26%) compared to control catheters (49%). The incidence of catheter colonisation was also significantly reduced (12% coated vs 33% uncoated). Data obtained show a significant reduction of catheter colonisation in CHSS catheters. There was no significant difference in the incidence of catheter-related bacteraemia (3% coated vs 7% uncoated). However, due to the overall low rate of CRI, we could not observe a significant reduction in the incidence of catheter-related bacteraemia.Conclusion: Our data show that the use of CHSS catheters in patients with haematological malignancy reduces the overall risk of catheter colonisation and CRI, although the incidence of catheter-related bacteremia was similar in both groups. [ABSTRACT FROM AUTHOR]- Published
- 2005
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214. Central venous catheter (CVC)-related infections in neutropenic patients: Guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO).
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Fätkenheuer, Gerd, Buchheidt, Dieter, Cornely, Oliver A., Fuhr, Hans-Georg, Karthaus, Meinolf, Kisro, Jens, Leithäuser, Malte, Salwender, Hans, Südhoff, Thomas, Szelényi, Hubert, and Weissinger, Florian
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NEUTROPENIA ,STAPHYLOCOCCUS aureus ,CATHETERS ,PATHOGENIC microorganisms - Abstract
Catheter-related infections cause considerable morbidity in hospitalised patients. The incidence does not seem to be higher in neutropenic patients than in non- neutropenic patients. Gram-positive bacteria (coagulase-negative staphylococci, Staphylococcus aureus) are the most frequently cultured pathogens, followed by Candida species. In contrast, Gram-negative bacteria play only a minor role in catheter-related infections. Positive blood cultures are the cornerstone in the diagnosis of catheter-related infections, while local signs of infection are only rarely present. However, a definite diagnosis generally requires the removal of the catheter and its microbiological examination. The role plate method with semiquantitative cultures (Maki) has been established as standard in most laboratories. Other standard procedures use quantitative techniques (Sherertz, Brun-Buisson) and are more sensitive. For therapy of catheter-related infections, antibiotics are administered according to the susceptibility of the cultured organism. Routine administration of gylcopepticed antibiotics is not indicated. Removal of the catheter has to be considered in any case of suspected catheter-related infection and is obligatory in Staphylococcus aureus and Candida infections. Tunnel or pocket infection of long-term catheters is always an indication for removal. In the future, the rate of catheter-related infections in neutropenic patients may be reduced by the use of catheters coated with antimicrobial agents. [ABSTRACT FROM AUTHOR]
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- 2003
215. Antimicrobial therapy of febrile complications after high-dose chemo-/radiotherapy and autologous hematopoietic stem cell transplantation: Guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO).
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Bertz, Hartmut, Auner, Holger W., Weissinger, Florian, Salwender, Hans-Jürgen, Einsele, Hermann, Egerer, Gerlinde, Sandherr, Michael, Schüttrumpf, Silke, Südhoff, Thomas, and Maschmeyer, Georg
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NEUTROPENIA ,DRUG therapy ,STEM cell transplantation ,HEMATOPOIETIC stem cells - Abstract
Infectious complications occur in 60–100% of patients following high-dose chemotherapy (HDC) and autologous hematopoietic stem cell transplantation (HSCT), and are commonly caused by Gram-negative aerobic bacteria (such as Pseudomonas aeruginosa and enterobacteriaceae) and Gram-positive cocci (such as enterococci, streptococci and staphylococci), which should be covered by empiric first-line antibiotic therapy. Less frequently, infections are caused by fungi and anaerobic bacteria, and initial therapy does not necessarily have to cover coagulase-negative staphylococci, oxacillin-resistant S. aureus (MRSA), anaerobic bacteria and fungi. Patients who already receive antibiotics and develop pulmonary infiltrates should immediately be treated with systemic antifungals. Patients with fever and diarrhea or other signs and symptoms of gastrointestinal or perianal infection should be treated with antibiotics covering anaerobic bacteria and enterococci. Clinically stable patients with skin infections or central venous catheter-related infections can be treated with standard empiric antibiotic therapy including a beta-lactam active against Pseudomonas aeruginosa with or without an aminoglycoside, and should only receive glycopeptides if they do not respond to first-line therapy within 72 hours, become clinically unstable, have severe mucositis, or when resistance against the empiric antibiotics is demonstrated. Recombinant hematopoietic growth factors should not be added routinely but may be considered in life-threatening situations such as invasive pulmonary mycoses or sepsis. [ABSTRACT FROM AUTHOR]
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- 2003
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216. Prophylaxis of invasive fungal infections in patients with hematological malignancies and solid tumors: Guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO).
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Cornely, Oliver A., Böhme, Angelika, Buchheidt, Dieter, Glasmacher, Axel, Kahl, Christoph, Karthaus, Meinolf, Kern, Winfried, Krüger, William, Maschmeyer, Georg, Ritter, Jörg, Salwender, Hans J., Sandherr, Michael, Schiel, Xaver, Schüttrumpf, Silke, Sieniawski, Michal, Silling, Gerda, Ullmann, Andrew J., and Wolf, Hans-Heinrich
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MYCOSES ,AMPHOTERICIN B ,TUMORS ,NEUTROPENIA - Abstract
Morbidity and mortality in patients with malignancies, especially leukemia and lymphoma, are increased by invasive fungal infections. Since diagnosis of invasive fungal infection is often delayed, antifungal prophylaxis is an attractive approach for patients expecting prolonged neutropenia. Antifungal prophylaxis has obviously attracted much interest resulting in dozens of clinical trials since the late 1970s. The non-absorbable polyenes are probably ineffective in preventing invasive fungal infections, but may reduce superficial mycoses. Intravenous amphotericin B and the newer azoles were used in clinical trials, but their role in antifungal prophylaxis is still not well defined. Allogeneic stem cell transplant recipients are at particularly high risk for invasive fungal infections. Other well described risk factors are neutropenia >10 days, corticosteroid therapy, sustained immunosuppression, graft versus host disease, and concomitant viral infections. The enormous study efforts are contrasted by a scarcity of risk stratified evidence based recommendations for clinical decision making. The objective of this review accumulating information on about 10.000 patients is to assess evidence based criteria primarily regarding the efficacy of antifungal prophylaxis in neutropenic cancer patients. [ABSTRACT FROM AUTHOR]
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- 2003
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217. Midostaurin plus Intensive Chemotherapy for Younger and Older Patients with AML and FLT3Internal Tandem Duplications
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Döhner, Hartmut, Weber, Daniela, Krzykalla, Julia, Fiedler, Walter, Wulf, Gerald, Salih, Helmut, Lübbert, Michael, Kühn, Michael W.M., Schroeder, Thomas, Salwender, Hans, Götze, Katharina, Westermann, Jörg, Fransecky, Lars, Mayer, Karin, Hertenstein, Bernd, Ringhoffer, Mark, Tischler, Hans-Joachim, Machherndl-Spandl, Sigrid, Schrade, Anika, Paschka, Peter, Gaidzik, Verena I., Theis, Frauke, Thol, Felicitas, Heuser, Michael, Schlenk, Richard F., Bullinger, Lars, Saadati, Maral, Benner, Axel, Larson, Richard, Stone, Richard, Döhner, Konstanze, and Ganser, Arnold
- Abstract
We conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3internal tandem duplication (ITD). Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. In comparison to historical controls, the addition of midostaurin to intensive therapy led to a significant improvement in outcome in younger and older patients with AML and FLT3-ITD. The AMLSG 16-10 trial is registered at clinicaltrialsregistry.eu(Eudra-CT number 2011-003168-63) and clinicaltrials.gov(NCT01477606).
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- 2022
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218. Next-Generation Sequencing (NGS)-Based Measurable Residual Disease (MRD) Monitoring in Acute Myeloid Leukemia with FLT3 Internal Tandem Duplication (FLT3-ITD+ AML) Treated with Additional Midostaurin
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Herzig, Julia K., Rücker, Frank G., Schmalbrock, Laura K., Blätte, Tamara J., Weber, Daniela, Skambraks, Sabrina, Kapp-Schwoerer, Silke, Corbacioglu, Andrea, Gaidzik, Verena I, Paschka, Peter, Panina, Ekaterina, Jahn, Nikolaus, Schrade, Anika, Theis, Frauke, Cocciardi, Sibylle, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Götze, Katharina S., Kindler, Thomas, Luebbert, Michael, Schlenk, Richard F., Thol, Felicitas, Heuser, Michael, Ganser, Arnold, Döhner, Hartmut, Bullinger, Lars, and Döhner, Konstanze
- Abstract
Kapp-Schwoerer: Jazz Pharmaceuticals: Honoraria, Research Funding. Paschka:Sunesis Pharmaceuticals: Consultancy; BerGenBio ASA: Research Funding; Novartis: Consultancy, Speakers Bureau; Otsuka: Consultancy; Pfizer: Consultancy, Speakers Bureau; Astellas Pharma: Consultancy, Speakers Bureau; Celgene: Consultancy, Other: Travel, accommodations or expenses; Astex Pharmaceuticals: Consultancy; Jazz Pharmaceuticals: Consultancy, Speakers Bureau; Agios Pharmaceuticals: Consultancy, Speakers Bureau; Amgen: Other; Janssen Oncology: Other; AbbVie: Other: Travel, accommodation or expenses, Speakers Bureau. Fiedler:Ariad/Incyte: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations; Novartis: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: support in medical writing; Daiichi Sankyo Oncology: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations; Morphosys: Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: support in medical writing; Servier: Honoraria, Other; BerGenBio ASA: Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations, support in medical writing, Research Funding; Gilead: Honoraria. Salih:Novartis: Consultancy; Pfizer: Consultancy; Philogen: Consultancy; Medigene: Consultancy; Synimmune: Consultancy, Research Funding. Salwender:Bristol-Myers Squibb/Celgene: Honoraria; Janssen-Cilag: Honoraria; Amgen: Honoraria; Takeda: Honoraria; Oncopeptides: Honoraria; Sanofi: Honoraria; GlaxoSmithKline: Honoraria; AbbVie: Honoraria. Götze:Celgene: Research Funding. Luebbert:Janssen: Research Funding. Schlenk:PharmaMar: Research Funding; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses, Research Funding, Speakers Bureau; Novartis: Speakers Bureau; Roche: Research Funding; AstraZeneca: Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Thol:Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Heuser:Daiichi Sankyo: Consultancy, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; Karyopharm: Research Funding; Abbvie: Consultancy; PriME Oncology: Honoraria; Amgen: Research Funding; Astellas: Research Funding; Roche: Research Funding; Stemline Therapeutics: Consultancy; Novartis: Consultancy, Honoraria, Research Funding; Janssen: Consultancy; BerGenBio ASA: Research Funding; Bayer: Consultancy, Research Funding. Ganser:Novartis: Consultancy; Celgene: Consultancy. Döhner:AstraZeneca: Consultancy, Honoraria; Sunesis: Research Funding; Roche: Consultancy, Honoraria; Pfizer: Research Funding; Oxford Biomedicals: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding; Helsinn: Consultancy, Honoraria; Jazz: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Astex: Consultancy, Honoraria; Astellas: Consultancy, Honoraria, Research Funding; AROG: Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Agios: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria; GEMoaB: Consultancy, Honoraria. Bullinger:Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Menarini: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Hexal: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees. Döhner:Jazz Pharmaceuticals: Consultancy, Honoraria, Research Funding; Daiichi Sankyo: Honoraria; Celgene: Consultancy, Honoraria; Sunesis Pharmaceuticals: Research Funding; Novartis: Honoraria, Research Funding; Pfizer: Research Funding; Bristol-Myers Squibb: Research Funding; Arog: Research Funding; Roche: Consultancy; Astex Pharmaceuticals: Consultancy; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Research Funding; Astellas Pharma: Consultancy; Agios: Consultancy; Abbvie: Consultancy.
- Published
- 2020
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219. Next-Generation Sequencing (NGS)-Based Measurable Residual Disease (MRD) Monitoring in Acute Myeloid Leukemia with FLT3Internal Tandem Duplication (FLT3-ITD+AML) Treated with Additional Midostaurin
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Herzig, Julia K., Rücker, Frank G., Schmalbrock, Laura K., Blätte, Tamara J., Weber, Daniela, Skambraks, Sabrina, Kapp-Schwoerer, Silke, Corbacioglu, Andrea, Gaidzik, Verena I, Paschka, Peter, Panina, Ekaterina, Jahn, Nikolaus, Schrade, Anika, Theis, Frauke, Cocciardi, Sibylle, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Götze, Katharina S., Kindler, Thomas, Luebbert, Michael, Schlenk, Richard F., Thol, Felicitas, Heuser, Michael, Ganser, Arnold, Döhner, Hartmut, Bullinger, Lars, and Döhner, Konstanze
- Abstract
Background:FLT3-ITD occurs in ~25% of adult AML patients (pts) and is associated with poor prognosis. MRD monitoring is of high prognostic relevance, but restricted to certain AML subtypes. FLT3-ITD represents an attractive target for MRD monitoring in particular in pts treated with a tyrosine kinase inhibitor. FLT3-ITD MRD monitoring is hampered by the broad heterogeneity of ITD length and insertion site (IS). NGS may overcome these limitations offering the opportunity for MRD monitoring in FLT3-ITD+AML.
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- 2020
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220. Quantitative Integrative Survival Prediction in Multiple Myeloma Patients Treated With Bortezomib-Based Induction, High-Dose Therapy and Autologous Stem Cell Transplantation.
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Hummel, Manuela, Hielscher, Thomas, Emde-Rajaratnam, Martina, Salwender, Hans, Beck, Susanne, Scheid, Christof, Bertsch, Uta, Goldschmidt, Hartmut, Jauch, Anna, Moreaux, Jérôme, Seckinger, Anja, and Hose, Dirk
- Subjects
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STEM cell transplantation , *MULTIPLE myeloma , *STEM cell treatment , *OVERALL survival , *REGRESSION analysis , *MONOCLONAL gammopathies - Abstract
PURPOSE: Given the high heterogeneity in survival for patients with multiple myeloma, it would be clinically useful to quantitatively predict the individual survival instead of attributing patients to two to four risk groups as in current models, for example, revised International Staging System (R-ISS), R2-ISS, or Mayo-2022-score. PATIENTS AND METHODS: Our aim was to develop a quantitative prediction tool for individual patient's 3-/5-year overall survival (OS) probability. We integrated established clinical and molecular risk factors into a comprehensive prognostic model and evaluated and validated its risk discrimination capabilities versus R-ISS, R2-ISS, and Mayo-2022-score. RESULTS: A nomogram for estimating OS probabilities was built on the basis of a Cox regression model. It allows one to translate the individual risk profile of a patient into 3-/5-year OS probabilities by attributing points to each prognostic factor and summing up all points. The nomogram was externally validated regarding discrimination and calibration. There was no obvious bias or overfitting of the prognostic index on the validation cohort. Resampling-based and external evaluation showed good calibration. The c-index of the model was similar on the training (0.76) and validation cohort (0.75) and significantly higher than for the R-ISS (P <.001) or R2-ISS (P <.01). CONCLUSION: In summary, we developed and validated individual quantitative nomogram-based OS prediction. Continuous risk assessment integrating molecular prognostic factors is superior to R-ISS, R2-ISS, or Mayo-2022-score alone. Better survival prediction in multiple myeloma—multimodal and continuous nomogram (instead of few arbitrary groups) [ABSTRACT FROM AUTHOR]
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- 2024
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221. Testing G-CSF responsiveness predicts the individual susceptibility to infection and consecutive treatment in recipients of high-dose chemotherapy
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Straka, Christian, Sandherr, Michael, Salwender, Hans, Wandt, Hannes, Metzner, Bernd, Hübel, Kai, Silling, Gerda, Hentrich, Marcus, Franke, Daniel, Schwerdtfeger, Rainer, Freund, Mathias, Sezer, Orhan, Giagounidis, Alexander, Ehninger, Gerhard, Grimminger, Wolfgang, Engert, Andreas, Schlimok, Günter, Scheid, Christof, Hellmann, Peter, Heinisch, Harald, Einsele, Hermann, Hinke, Axel, and Emmerich, Bertold
- Abstract
The individual risk of infection and requirements for medical treatment after high-dose chemotherapy have been unpredictable. In this prospective, multicenter, open-label study we investigated the potential of granulocyte colony-stimulating factor (G-CSF) responsiveness as a predictor. A total of 168 patients with multiple myeloma or lymphoma received a single dose of subcutaneous G-CSF (lenograstim, 263 μg) after high-dose chemotherapy. Highly variable leukocyte peaks were measured and grouped as low (quartile 1; leukocytes 100-10 100/μL), medium (quartile 2; leukocytes > 10 100-18 300/μL), and high (quartiles 3/4; leukocytes > 18 300-44 800/μL). G-CSF responsiveness (low vs medium vs high) was inversely correlated with febrile neutropenia (77% vs 60% vs 48%; P = .0037); the rate of infection, including fever of unknown origin (91% vs 67% vs 54%; P < .0001); days with intravenous antibiotics (9 vs 6 vs 5; P < .0001); and antifungal therapy (P = .042). In multivariate analysis, G-CSF responsiveness remained the only factor significantly associated with infection (P = .016). In addition, G-CSF responsiveness was inversely correlated with grade 3/4 oral mucositis (67% vs 33% vs 23%; P < .0001). G-CSF responsiveness appears as a signature of the myeloid marrow reserve predicting defense against neutropenic infection after intensive chemotherapy. This study is registered at http://www.clinicaltrials.gov as NCT01085058.
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- 2011
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222. Addition of Isatuximab to Lenalidomide, Bortezomib and Dexamethasone As Induction Therapy for Newly-Diagnosed, Transplant-Eligible Multiple Myeloma Patients: The Phase III GMMG-HD7 Trial
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Goldschmidt, Hartmut, Mai, Elias K, Nievergall, Eva, Fenk, Roland, Bertsch, Uta, Tichy, Diana, Besemer, Britta, Dürig, Jan, Schroers, Roland, Metzler, Ivana v., Haenel, Mathias, Mann, Christoph, Asemissen, Anne-Marie, Heilmeier, Bernhard, Huhn, Stefanie, Kriegsmann, Katharina, Weinhold, Niels, Luntz, Steffen P., Holderried, Tobias A.W., Trautmann-Grill, Karolin, Gezer, Deniz, Klaiber-Hakimi, Maika, Mueller, Martin, Khandanpour, Cyrus, Knauf, Wolfgang, Munder, Markus, Geer, Thomas, Riesenberg, Hendrik, Thomalla, Joerg, Hoffmann, Martin, Raab, Marc-Steffen, Salwender, Hans, and Weisel, Katja
- Abstract
Background:In newly-diagnosed multiple myeloma (NDMM), lenalidomide/bortezomib/dexamethasone (RVd) is one of the most widely used combination regimens. Anti-CD38 monoclonal antibodies (CD38-moAb) increase efficacy when added to standard-of-care regimens. Here we present the first primary endpoint of the randomized, open-label, multicenter, phase III GMMG-HD7 trial, comparing RVd without (arm IA) or with the CD38-moAb isatuximab (Isa, arm IB) with regard to the rate of minimal residual disease (MRD) negativity after induction therapy in patients with transplant-eligible NDMM.
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- 2021
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223. Midostaurin Plus Intensive Chemotherapy for Younger and Older Patients with Acute Myeloid Leukemia and FLT3 Internal Tandem Duplications
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Döhner, Hartmut, Weber, Daniela, Krzykalla, Julia, Fiedler, Walter, Wulf, Gerald, Salih, Helmut R., Lübbert, Michael, Kühn, Michael W.M., Schroeder, Thomas, Salwender, Hans, Götze, Katharina S., Westermann, Jörg, Fransecky, Lars, Mayer, Karin, Hertenstein, Bernd, Ringhoffer, Mark, Tischler, Hans-Joachim, Machherndl-Spandl, Sigrid, Schrade, Anika, Paschka, Peter, Gaidzik, Verena I, Theis, Frauke, Thol, Felicitas R, Heuser, Michael, Schlenk, Richard F., Bullinger, Lars, Saadati, Maral, Benner, Axel, Döhner, Konstanze, and Ganser, Arnold
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- 2021
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224. Elotuzumab in Combination with Lenalidomide, Bortezomib, Dexamethasone and Autologous Transplantation for Newly-Diagnosed Multiple Myeloma: Results from the Randomized Phase III GMMG-HD6 Trial
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Goldschmidt, Hartmut, Mai, Elias K, Bertsch, Uta, Besemer, Britta, Haenel, Mathias, Miah, Kaya, Fenk, Roland, Schlenzka, Jana, Munder, Markus, Dürig, Jan, Blau, Igor Wolfgang, Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Kunz, Christina, Neubauer, Andreas, Scheid, Christof, Schroers, Roland, Metzler, Ivana v., Schieferdecker, Aneta, Thomalla, Joerg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe M., Kunz, Christian, Hensel, Manfred, Seidel-Glaetzer, Andrea, Weisel, Katja, Raab, Marc-Steffen, and Salwender, Hans
- Abstract
Background:Treatment regimens including a proteasome inhibitor, immunomodulating agent and a monoclonal antibody (moAb) play an emerging role in the treatment of newly-diagnosed multiple myeloma (NDMM). This multicenter phase III trial of the German-speaking Myeloma Multicenter Group (GMMG HD6) investigated the addition of the anti-SLAMF7 moAb elotuzumab to lenalidomide / bortezomib / dexamethasone (RVd) in induction and consolidation therapy as well as to lenalidomide maintenance treatment in transplant-eligible NDMM.
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- 2021
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225. Prediction of Early Death and Severe Infections during Novel Agent-Based Induction Therapy in Newly-Diagnosed Multiple Myeloma: An Intergroup Analysis from the German Speaking Myeloma Multicenter Group, the Dutch-Belgian Cooperative Trial Group for Hematology Oncology Foundation and the European Myeloma Network
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Mai, Elias K, Hielscher, Thomas, Bertsch, Uta, Salwender, Hans, Zweegman, Sonja, Munder, Markus, Pantani, Lucia, Brossart, Peter, Beksac, Meral, Blau, Igor Wolfgang, Raab, Marc-Steffen, Dürig, Jan, Giesen, Nicola, Besemer, Britta, Fenk, Roland, Reimer, Peter, van der Holt, Bronno, Haenel, Mathias, Metzler, Ivana v., Graeven, Ullrich, Boccadoro, Mario, Scheid, Christof, Dimopoulos, Meletios A., Weisel, Katja, Cavo, Michele, Sonneveld, Pieter, and Goldschmidt, Hartmut
- Abstract
Background:During the past decade, prognostic tools and outcomes of patients with newly-diagnosed multiple myeloma (NDMM) markedly improved. Data from clinical trials evaluating early morbidity and mortality including patients with transplant-eligible NDMM treated with novel agents are scarce. Thus, we aimed to analyze early morbidity and mortality in this patient cohort, devise and validate a predictive score to identify patients at risk.
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- 2021
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226. Final Overall Survival Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma
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Kumar, Shaji, Harrison, Simon J, Cavo, Michele, de la Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina J., Hungria, Vania, Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Onishi, Maika, Ku, Grace, Pothacamury, Rajvineeth Kumar, Sehgal, Vasudha, Masud, Abdullah A., Ross, Jeremy A., Dobkowska, Edyta, and Moreau, Philippe
- Abstract
Background:Multiple myeloma (MM) is a heterogenous cancer of terminally differentiated plasma cells that typically express elevated levels of antiapoptotic proteins, such as BCL-2. Venetoclax (Ven), a highly selective, potent, oral BCL-2 inhibitor, induces apoptosis in MM cells, and when combined with bortezomib and dexamethasone showed promising efficacy in patients (pts) with relapsed/refractory MM (RRMM; Moreau et al. Blood. 2017;130:2392-2400). The Phase 3 BELLINI study primary analysis showed significantly improved response rates and progression-free survival (PFS) in pts with RRMM treated with Ven added to bortezomib and dexamethasone versus placebo (Pbo); however, increased mortality was observed in the Ven group (Kumar et al. Lancet Oncol. 2020;21:1630-1642). At the initial data cutoff (November 26, 2018), the PFS hazard ratio (HR) was 0.63 (95% CI, 0.44-0.90) and overall survival (OS) HR was 2.03 (95% CI, 1.04-3.95). Pts with t(11;14) translocation or high BCL2expression showed improved responses and PFS without increased mortality. Here, we present updated safety and efficacy data from the prespecified final OS analysis.
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- 2021
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227. Catheter-related infection and thrombosis of the internal jugular vein in hematologic-oncologic patients undergoing chemotherapy
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Harter, Christoph, Salwender, Hans Jürgen, Bach, Alfons, Egerer, Gerlinde, Goldschmidt, Hartmut, and Ho, Anthony D.
- Abstract
Catheter-related venous thrombosis is one of the most frequent complications of central venous catheters (CVCs). This complication occurs in 4 40% of patients with hematologic malignancies receiving conventional chemotherapy after placement of CVCs. The objective of this prospective study was to assess whether a silver-coated CVC poses an additional risk in the development of catheter-related thrombosis in hematologic-oncologic patients. Patients were randomized to receive either silver-coated polyurethane catheters (BactiGuard; Metacot, Stockholm, Sweden) or uncoated standard polyurethane catheters (Cavatheter, Fresenius AG, Bad Homburg, Germany) for central venous access. Silver-coated catheters (n = 120) and standard catheters (n = 113) were inserted into the jugular vein in 233 consecutive patients. Variables that may be significant for the development of thrombosis were comparable in the two groups. After removal of the CVC, the patency of both jugularian veins internal as well as external was assessed with real-time ultrasound (Sonolayer-SAL-35A; Toshiba, Tokyo, Japan). Four of 233 patients (1.5%) were found to have venous thrombosis. Incomplete occlusion of the internal jugular vein occurred in 2 patients (0.75%, parietal thrombosis), and complete thrombosis, although clinically silent, was found in 2 patients (0.75%). There was no difference between patients with silver-coated and uncoated CVCs. The authors concluded that this novel silver-coated CVC does not cause a higher rate of central venous thrombosis compared with standard CVCs. The low overall incidence of central venous thrombosis might be attributed to the routine application of low-dose heparin in our patients during chemotherapeutic treatment. Cancer 2002;94:24551. © 2002 American Cancer Society.
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- 2002
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228. Successful Harvesting of Peripheral Hematopoietic Stem Cells after Induction Treatment with Bortezomib, Adriamycin, Dexamethasone (PAD) in Patients with Newly Diagnosed Multiple Myeloma (MM)
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Goldschmidt, Hartmut, Lokhorst, Henk M., Bertsch, Uta, van der Holt, Bronno, Jarari, Laila el, Salwender, Hans-Jürgen, Zweegman, Sonja, Vellenga, Edo, Schubert, Jörg, Blau, Igor W., Jie, Asiong, Beverloo, Berna, Hose, Dirk, van de Velde, Helgi, Schaafsma, Martyn Ronald, Kersten, Marie Jose, Delforge, Michel, de Weerdt, Okke, Van der Griend, Rene, Wijermans, Pierre, Martin, Hans, Scheid, Christof, Hänel, Mathias, and Schmidt-Wolf, Ingo G.H.
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- 2008
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229. Normalization of serum free light chains during therapy in the MM5 trial predicts prolonged progression free survival and overall survival.
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Haas, Eva-Maria, Salwender, Hans J., Mai, Elias K., Dürig, Jan, Weisel, Katja, Tichy, Diana, Benner, Axel, Kunz, Christina, Hielscher, Thomas, Bertsch, Uta, Besemer, Britta, Merz, Maximilian, Munder, Markus, Lindemann, Hans-Walter, Hügle-Dörr, Barbara, Giessen, Nicola, Hose, Dirk, Seckinger, Anja, Huhn, Stefanie, and Luntz, Steffen
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- 2019
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230. A Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma.
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Kumar, Shaji, Harrison, Simon J., Cavo, Michele, Rubia, Javier DE.LA., Popat, Rakesh, Gasparetto, Cristina J., Hungria, Vania, Salwender, Hans J., Suzuki, Kenshi, Kim, Inho, Punnoose, Elizabeth, Hong, Wan-Jen, Freise, Kevin J., Sood, Anjla, Jalaluddin, Muhammad, Ross, Jeremy, Ward, James E., Maciag, Paulo, and Moreau, Philippe
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- 2019
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231. Comparison of bortezomib versus lenalidomide maintenance therapy in newly-diagnosed, transplant-eligible multiple myeloma: Results from the phase III GMMG-HD4 and -MM5 trials.
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Mai, Elias K., Baertsch, Marc-A., Hielscher, Thomas, Bertsch, Uta, Schlenzka, Jana, Salwender, Hans J., Munder, Markus, Fuhrmann, Stephan, Duehrsen, Ulrich, Brossart, Peter, Neben, Kai, Raab, Marc S., Jauch, Anna, Seckinger, Anja, Hose, Dirk, Luntz, Steffen, Sonneveld, Pieter, Lokhorst, Henk, Martin, Hans, and Lindemann, Hans-Walter
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- 2019
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232. All-Trans Retinoic Acid and Gemtuzumab Ozogamicin as Adjunct To Salvage Therapy in Primary Refractory Acute Myeloid Leukemia: Results of Consecutive Phase II Studies of the AMLSG.
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Schlenk, Richard F., Doehner, Konstanze, Kerz, Martina, Hartmann, Frank, del Valle, Francesco, Glasmacher, Axel, Pralle, Hans, Goetze, Katharina, Koller, Elisabeth, Gastl, Guenther, Mergenthaler, Hans G., Salwender, Hans, Kirchen, Heinz, Haase, Detlef, Kremers, Stephan, Nerl, Christoph, Theobald, Matthias, Matzdorff, Axel C., Ganser, Arnold, and Doehner, Hartmut
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- 2005
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233. Bortezomib-Based Induction and Maintenance Overcomes the Negative Prognostic Impact of Renal Impairment and del17p in Transplant-Eligible Myeloma Patients: Long Term Results from the Phase III HOVON-65/GMMG-HD4 Study after Median 137 Months Follow up
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Scheid, Christof, Lokhorst, Henk, Blau, Igor W, Van Der Holt, Bronno, Bertsch, Uta, Zweegman, Sonja, Weisel, Katja, Vellenga, Edo, Kersten, Marie José, Croockewit, Sandra, Mai, Elias K, Raymakers, Reinier, Hose, Dirk, Jauch, Anna, Hillengass, Jens, Stevens-Kroef, Marian, Raab, Marc S, Neben, Kai, Stilgenbauer, Stephan, Broyl, Annemiek, Lindemann, Hans-Walter, Bos, Gerard, Brossart, Peter, van Marwijk Kooij, Marinus, Ypma, Paula F, Dührsen, Ulrich, Schaafsma, Ron, Hielscher, Thomas, Salwender, Hans, Goldschmidt, Hartmut, and Sonneveld, Pieter
- Abstract
Scheid: Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Amgen: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Takeda: Honoraria, Research Funding; Novartis: Honoraria, Research Funding. Bertsch:Celgene: Other: travel support; Sanofi: Other: travel support. Zweegman:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Research Funding. Weisel:Celgene: Consultancy, Honoraria, Research Funding; Juno: Consultancy; Bristol-Myers Squibb: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Research Funding; GSK: Honoraria; Adaptive Biotech: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria. Kersten:Gilead: Honoraria; Kite Pharma: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Novartis: Honoraria; Bristol-Myers Squibb: Honoraria, Research Funding; Mundipharma: Honoraria, Research Funding; Miltenyi: Honoraria; Roche: Honoraria, Research Funding; Takeda Oncology: Research Funding; Celgene: Honoraria, Research Funding. Mai:Mundipharma: Other: travel support; Takeda: Honoraria, Other: travel support, Research Funding; Janssen: Consultancy, Honoraria, Other: travel support; Celgene: Consultancy, Honoraria, Other: travel support. Hillengass:Amgen: Consultancy, Honoraria; Janssen: Honoraria. Stilgenbauer:AbbVie, AstraZeneca, Celgene, Gilead Sciences, Inc., GSK, Hoffmann La-Roche, Janssen, Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau. Broyl:Celgene, amgen, Janssen,Takeda: Honoraria. Bos:Kiadis Pharma: Other: Shareholder (of Cytosen, acquired by Kiadis); Celgene: Research Funding. Dührsen:Amgen: Consultancy, Honoraria, Research Funding; CPT: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Roche: Honoraria, Research Funding; Teva: Honoraria; Novartis: Consultancy, Honoraria; Alexion: Honoraria; Gilead: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Janssen: Honoraria; Celgene: Research Funding. Salwender:Celgene: Honoraria, Other: Travel or accommodations; Sanofi: Honoraria, Other: Travel or accommodations; Takeda: Honoraria, Other: Travel or accommodations; Bristol-Myers Squibb: Honoraria, Other: Travel or accommodations; AbbVie: Honoraria; Amgen: Honoraria, Other: Travel or accommodations; Janssen Cilag: Honoraria, Other: Travel or accommodations. Goldschmidt:Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Molecular Partners: Research Funding; Dietmar-Hopp-Stiftung: Research Funding; Mundipharma: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; John-Hopkins University: Research Funding; Amgen: Consultancy, Research Funding; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Chugai: Honoraria, Research Funding; John-Hopkins University: Research Funding; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; MSD: Research Funding; Janssen: Consultancy, Research Funding. Sonneveld:Amgen: Honoraria, Research Funding; BMS: Honoraria; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; SkylineDx: Research Funding.bortezomib maintenance thalidomide maintenance
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- 2019
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234. Updated Analysis of Bellini, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
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Moreau, Philippe, Harrison, Simon, Cavo, Michele, De La Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Gay, Francesca, Mikala, Gábor, Punnoose, Elizabeth A, Hong, Wan-Jen, Sood, Anjla, Jalaluddin, Muhammad, Ross, Jeremy A., Ward, James E., Maciag, Paulo C., and Kumar, Shaji K.
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- 2019
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235. Patterns of Renal Recovery and Toxicity with Novel Agent-Based Induction Triplets in Newly Diagnosed Multiple Myeloma - an Analysis of Two Prospective Studies By the German DSMM Myeloma Study Group
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Bachmann, Friederike, Held, Swantje, Engelhardt, Monika, Langer, Christian, Wolleschak, Denise, Fleissner, Janik, Mügge, Lars-Olof, Duerk, Heinz, Schreder, Martin, Schaefer-Eckart, Kerstin, Blau, Igor-Wolfgang, Gramatzki, Martin, Liebisch, Peter, Reichle, Albrecht, Metzler, Ivana, Bassermann, Florian, Metzner, Bernd, Röllig, Christoph, Hertenstein, Bernd, Dechow, Tobias, Jung, Wolfram, Ostermann, Helmut, Hebart, Holger, Maschmeyer, Georg, Salwender, Hans Jürgen, von Lilienfeld-Toal, Marie, Eckardt, Kai-Uwe, Straka, Christian, Einsele, Hermann, and Knop, Stefan
- Abstract
Mügge: Celgene: Research Funding; Celgene, Janssen: Honoraria. Schreder:Janssen, Celgene: Consultancy, Honoraria. Schaefer-Eckart:Pfizer, Janssen, Celgene: Honoraria. Metzler:Bristol-Myers Squibb, Celgene: Consultancy, Honoraria. Hertenstein:RS Media: Research Funding. Maschmeyer:Gilead, Janssen Cilag, Astra Zeneca; BMS, Merk-Serono: Honoraria. Salwender:Janssen Cilag: Consultancy, Honoraria, Other: Travel grants; Celgene: Honoraria, Other: Travel grants; AMGEN: Honoraria, Other: Travel grants; Sanofi: Honoraria, Other: Travel grants; Bristol-Myers Squibb: Honoraria, Other: Travel grants; Takeda: Honoraria, Other: Travel grants; Oncopeptides: Honoraria, Other: Travel Grants. von Lilienfeld-Toal:Celgene, Oncopeptides: Consultancy, Honoraria. Straka:Celgene, Janssen, AMGEN: Consultancy, Research Funding, Speakers Bureau. Knop:Janssen, AMGEN, Bristol-Myers Squibb, Celgene: Consultancy, Honoraria.Lenalidomide, adriamycin, dexamethsone in newly diagnosed multiple myeloma
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- 2019
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236. T(11;14) and High BCL2 Expression Are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 Bellini Study
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Harrison, Simon, Cavo, Michele, De La Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Moreau, Philippe, Spencer, Andrew, O'Dwyer, Michael E, Garg, Mamta, Punnoose, Elizabeth A, Jalaluddin, Muhammad, Jia, Jia, Yang, Xiaoqing, Sun, Yan, Ward, James E., Maciag, Paulo C., Ross, Jeremy A., and Kumar, Shaji K.
- Abstract
Harrison: GSK: Consultancy, Research Funding; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: investigator on studies, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Cavo:celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; novartis: Honoraria; takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; bms: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. De La Rubia:AMGEN: Consultancy; Takeda: Consultancy; AbbVie: Consultancy; Janssen: Consultancy; Celgene Corporation: Consultancy. Popat:Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel, accommodations, expenses; Janssen: Honoraria, Other: travel support to meetings; GSK: Consultancy, Honoraria; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Other: travel, accommodations, expenses. Gasparetto:Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Hungria:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Salwender:Amgen: Honoraria, Other: Travel or accommodations; Bristol-Myers Squibb: Honoraria, Other: Travel or accommodations; Janssen Cilag: Honoraria, Other: Travel or accommodations; Sanofi: Honoraria, Other: Travel or accommodations; Celgene: Honoraria, Other: Travel or accommodations; AbbVie: Honoraria; Takeda: Honoraria, Other: Travel or accommodations. Suzuki:Ono: Research Funding; BMS: Honoraria, Research Funding; Takeda: Honoraria; Janssen: Honoraria; Celgene: Honoraria. Moreau:Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria. Spencer:AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Specialised Therapeutics Australia: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. O'Dwyer:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy; GlycoMimetics Inc: Research Funding; BMS: Research Funding; Onkimmune: Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Research Funding. Garg:Janssen: Honoraria; Novartis, Janssen: Research Funding; Janssen, Takeda, Novartis: Other: Travel expenses. Punnoose:Roche: Other: Stock/stock options; Genentech, Inc.: Employment. Jalaluddin:AbbVie: Employment, Other: Stock/stock options. Jia:AbbVie: Employment, Other: Stock/stock options. Yang:AbbVie: Employment, Other: Stock/stock options. Sun:AbbVie: Employment, Other: Stock/stock options. Ward:AbbVie: Employment, Other: Stock/stock options. Maciag:AbbVie: Employment, Other: Stock/stock options. Ross:AbbVie: Employment, Other: Stock/stock options. Kumar:Takeda: Research Funding; Celgene: Consultancy, Research Funding; Janssen: Consultancy, Research Funding.Venetoclax is a BCL-2 inhibitor that is FDA-approved in some indications. This presentation will focus on venetoclax for treatment of multiple myeloma, which is not an approved indication.
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- 2019
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237. Validation and Improvement Opportunities of the Revised International Staging System for Multiple Myeloma: An Analysis on Mature Data from European Clinical Trials within the Harmony Big Data Platform
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D'Agostino, Mattia, Waage, Anders, Lahuerta, Juan-José, Bertsch, Uta, Zamagni, Elena, Bullinger, Lars, Larocca, Alessandra, Mateos, Maria-Victoria, Van De Donk, Niels W. C. J., Salwender, Hans Jürgen, Bladé, Joan, van der Holt, Bronno, Tacchetti, Paola, Ciccone, Giovannino, Zweegman, Sonja, Goldschmidt, Hartmut, Cavo, Michele, San-Miguel, Jesús, Sonneveld, Pieter, Boccadoro, Mario, and Hernández-Rivas, Jesús María
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Lahuerta: Takeda, Amgen, Celgene and Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Bertsch:Celgene: Other: travel support; Sanofi: Other: travel support. Zamagni:Celgene Corporation: Honoraria, Other: Advisory board, Speakers Bureau; Janssen: Honoraria, Other: Advisory board, Speakers Bureau; Amgen: Honoraria, Other: Advisory board, Speakers Bureau; BMS: Honoraria, Other: Advisory Board, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Sanofi: Honoraria, Other: Advisory Board, Speakers Bureau. Bullinger:Seattle Genetics: Honoraria; Janssen: Honoraria; Hexal: Honoraria; Gilead: Honoraria; Celgene: Honoraria; Daiichi Sankyo: Honoraria; Bristol-Myers Squibb: Honoraria; Bayer: Other: Financing of scientific research; Astellas: Honoraria; Amgen: Honoraria; Abbvie: Honoraria; Sanofi: Honoraria; Pfizer: Honoraria; Novartis: Honoraria; Menarini: Honoraria; Jazz Pharmaceuticals: Honoraria. Larocca:Amgen: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Mateos:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pharmamar: Membership on an entity's Board of Directors or advisory committees; Adaptive: Honoraria; EDO: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Van De Donk:Roche: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees; Celgene Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; AMGEN: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding. Salwender:Janssen Cilag: Consultancy, Honoraria, Other: Travel grants; Celgene: Honoraria, Other: Travel grants; AMGEN: Honoraria, Other: Travel grants; Sanofi: Honoraria, Other: Travel grants; Bristol-Myers Squibb: Honoraria, Other: Travel grants; Takeda: Honoraria, Other: Travel grants; Oncopeptides: Honoraria, Other: Travel Grants. Bladé:Jansen, Celgene, Takeda, Amgen and Oncopeptides: Honoraria. Tacchetti:Janssen: Honoraria; BMS: Honoraria; Oncopeptides: Honoraria, Speakers Bureau; Celgene: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau. Zweegman:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Goldschmidt:Chugai: Honoraria, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; MSD: Research Funding; Dietmar-Hopp-Foundation: Other: Grants and/or provision of Investigational Medicinal Product; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Molecular Partners: Research Funding; Novartis: Honoraria, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding; ArtTempi: Honoraria; Amgen: Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Mundipharma: Research Funding; John Hopkins University: Other: Grants and/or provision of Investigational Medicinal Product. Cavo:bms: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; novartis: Honoraria; takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau. San-Miguel:Amgen, Bristol-Myers Squibb, Celgene, Janssen, MSD, Novartis, Roche, Sanofi, and Takeda: Consultancy, Honoraria. Sonneveld:SkylineDx: Research Funding; Takeda: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; BMS: Honoraria; Amgen: Honoraria, Research Funding. Boccadoro:Sanofi: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; AbbVie: Honoraria; Mundipharma: Research Funding; Celgene: Honoraria, Research Funding.This presentation includes discussion of off-label use of a drug or drugs for the treatment of multiple myeloma.
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- 2019
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238. Physical Function, Pain Severity, and Fatigue in Patients with Relapsed/Refractory Multiple Myeloma: Health-Related Quality of Life Results in Patients Receiving Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone
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Gasparetto, Cristina, Popat, Rakesh, Kumar, Shaji K., Cavo, Michele, de la Rubia, Javier, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Maciel, James, Hsiao, Liang-Tsai, Moreau, Philippe, Harrison, Simon, Jia, Jia, Karve, Sudeep, Ma, Esprit, Devine, Jacob, and Benjamin, Katy
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Background:Despite treatment advances, multiple myeloma (MM) remains a condition with high unmet medical need as patients (pts) relapse and become resistant to therapy. MM pts experience a range of serious disease-related symptoms and side effects impacting their functioning and health-related quality of life (HRQL). The median overall survival (OS) has improved with the advent of new treatments in the last two decades, however, the impact of newer combination treatments on pt quality of life remains unknown (Beckner, N et al. Cancer Res. 2011;183:25; Bharat, N et al. J Clin Oncol2019;37:15(suppl):8039). Venetoclax is a novel, orally bioavailable small molecule inhibitor of BCL-2 activity in MM. In the Phase 3 double-blind, randomized clinical trial (M14-031, BELLINI) progression free survival (PFS) was studied in relapsed/refractory (RR) MM pts receiving venetoclax or placebo in combination with bortezomib and dexamethasone. In addition, patient-reported outcomes (PRO) data focused on physical functioning, pain, and fatigue from BELLINI were evaluated to better understand the overall impact on pt HRQL of adding venetoclax to bortezomib and dexamethasone-based doublet therapy.
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- 2019
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239. MCT1 As Molecularly Validated Predictive Marker for Lenalidomide-Maintenance Therapy in Multiple Myeloma
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Stroh, Jacob, Seckinger, Anja, Heider, Michael, Eichner, Ruth, Emde, Martina, Salwender, Hans, Bertsch, Uta, Goldschmidt, Hartmut, Weisel, Katja, Scheid, Christof, Hose, Dirk, and Bassermann, Florian
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Introduction:
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- 2019
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240. T(11;14) and High BCL2Expression Are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 Bellini Study
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Harrison, Simon, Cavo, Michele, De La Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Moreau, Philippe, Spencer, Andrew, O'Dwyer, Michael E, Garg, Mamta, Punnoose, Elizabeth A, Jalaluddin, Muhammad, Jia, Jia, Yang, Xiaoqing, Sun, Yan, Ward, James E., Maciag, Paulo C., Ross, Jeremy A., and Kumar, Shaji K.
- Abstract
Background: Overexpression of the anti-apoptotic BCL-2 protein promotes multiple myeloma (MM) cell survival. Venetoclax (Ven) is a highly selective, potent, oral BCL-2 inhibitor that induces apoptosis and has shown synergistic activity with bortezomib (B) and dexamethasone (d). Phase 1 studies in relapsed/refractory (RR) MM demonstrated encouraging clinical efficacy of Ven + d in t(11;14) MM and in a broader patient (pt) population in combination with Bd. Recent results from the Phase 3 BELLINI study of Ven vs placebo (Pbo) + Bd in pts with RRMM demonstrated that pts treated with Ven + Bd had improved clinical response rates and progression-free survival (PFS) vs Pbo, although the overall survival (OS) result was in favor of Pbo. Subgroup analyses showed different efficacy and survival outcomes based on tumor cytogenetics and BCL-2 expression. Results of pre-specified subgroup analyses and additional retrospective correlative biomarker analyses in the Phase 3 BELLINI study are described herein.
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- 2019
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241. Cystic transformation of focal lesions after therapy is associated with remission but adverse outcome in myeloma.
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Merz, Maximilian, Hielscher, Thomas, Mai, Elias Karl, Seckinger, Anja, Hose, Dirk, Jauch, Anna, Sauer, Sandra, Luntz, Steffen, Bertsch, Uta, Raab, Marc S., Neben, Kai, Salwender, Hans, Blau, Igor W., Lindemann, Hans-Walter, Dürig, Jan, Scheid, Christof, Haenel, Mathias, Weisel, Katja, Weber, Tim, and Delorme, Stefan
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MULTIPLE myeloma treatment ,MULTIPLE myeloma diagnosis ,CYCLOPHOSPHAMIDE ,MELPHALAN ,DRUG dosage - Published
- 2019
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242. Prospective target assessment and multimodal prediction of survival for personalized and risk-adapted treatment strategies in multiple myeloma in the GMMG-MM5 multicenter trial.
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Hose, Dirk, Beck, Susanne, Salwender, Hans, Emde, Martina, Bertsch, Uta, Kunz, Christina, Scheid, Christoph, Hänel, Mathias, Weisel, Katja, Hielscher, Thomas, Raab, Marc S., Goldschmidt, Hartmut, Jauch, Anna, Moreaux, Jérôme, and Seckinger, Anja
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MULTIPLE myeloma ,THERAPEUTICS ,GENE expression profiling ,RISK assessment - Abstract
Background: Personalized and risk-adapted treatment strategies in multiple myeloma prerequisite feasibility of prospective assessment, reporting of targets, and prediction of survival probability in clinical routine. Our aim was first to set up and prospectively test our experimental and analysis strategy to perform advanced molecular diagnostics, i.e., interphase fluorescence in-situ hybridization (iFISH) in ≥ 90% and gene expression profiling (GEP) in ≥ 80% of patients within the first cycle of induction chemotherapy in a phase III trial, seen as prerequisite for target expression-based personalized treatment strategies. Secondly, whether the assessment of risk based on the integration of clinical, cytogenetic, and expression-based parameters ("metascoring") is possible in this setting and superior to the use of single prognostic factors. Methods: We prospectively performed plasma cell purification, GEP using DNA-microarrays, and iFISH within our randomized multicenter GMMG-MM5-trial recruiting 604 patients between July 2010 and November 2013. Patient data were analyzed using our published gene expression report (GEP-R): after quality and identity control, integrated risk assessment (HM metascore) and targets were reported in clinical routine as pdf-document. Results: Bone marrow aspirates were obtained from 573/604 patients (95%) and could be CD138-purified in 559/573 (97.6%). Of these, iFISH-analysis was possible in 556 (99.5%), GEP in 458 (82%). Identity control using predictors for sex, light and heavy chain type allowed the exclusion of potential sample interchanges (none occurred). All samples passed quality control. As exemplary targets, IGF1R-expression was reported expressed in 33.1%, AURKA in 43.2% of patients. Risk stratification using an integrated approach, i.e., HM metascore, delineated 10/77/13% of patients as high/medium/low risk, transmitting into significantly different median progression-free survival (PFS) of 15 vs. 39 months vs. not reached (NR; P < 0.001) and median overall survival (OS) of 41 months vs. NR vs. NR (P < 0.001). Five-year PFS and OS-rates were 5/31/54% and 25/68/98%, respectively. Survival prediction by HM metascore (Brier score 0.132, P < 0.001) is superior compared with the current gold standard, i.e., revised ISS score (0.137, P = 0.005). Conclusions: Prospective assessment and reporting of targets and risk by GEP-R in clinical routine are feasible in ≥ 80% of patients within the first cycle of induction chemotherapy, simultaneously allowing superior survival prediction. [ABSTRACT FROM AUTHOR]
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- 2019
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243. Treatment Response and Long-Term Survival in Multiple Myeloma in the GMMG-HD4 Trial - Neither Profit All Molecular Entities Alike, Nor Are Remissions to Different Regimen Equal
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Seckinger, Anja, Salwender, Hans Jürgen, Martin, Hans, Scheid, Christof, Hielscher, Thomas, Bertsch, Uta, Hummel, Manuela, Jauch, Anna, Knauf, Wolfgang, Emde, Martina, Beck, Susanne, Neben, Kai, Lokhorst, Henk M., van der Holt, Bronno, Duehrsen, Ulrich, Dürig, Jan, Lindemann, Hans-Walter, Schmidt-Wolf, Ingo, Haenel, Mathias, Lathan, Bernd, Raab, Marc S, Müller-Tidow, Carsten, Sonneveld, Pieter, Blau, Igor Wolfgang, Hillengass, Jens, Weisel, Katja, Goldschmidt, Hartmut, and Hose, Dirk
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Seckinger: Celgene: Research Funding; Sanofi: Research Funding; EngMab: Research Funding. Salwender:Novartis: Honoraria, Other: travel suppport, Research Funding; Amgen: Honoraria, Other: travel suppport, Research Funding; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding; Celgene: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Janssen: Honoraria, Other: travel support, Research Funding. Scheid:Celgene: Honoraria; Janssen: Honoraria. Knauf:Janssen: Consultancy; AbbVie: Consultancy; Celgene: Consultancy, Honoraria; Gilead Sciences: Consultancy; Roche: Consultancy; Amgen: Consultancy, Honoraria; Mundipharma: Consultancy. Duehrsen:AbbVie: Consultancy, Honoraria; Amgen: Research Funding; Janssen: Honoraria; Celgene: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Gilead: Consultancy, Honoraria. Dürig:Roche: Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria; Celgene: Honoraria. Schmidt-Wolf:Janssen: Research Funding; Novartis: Research Funding. Haenel:Novartis: Honoraria; Amgen: Honoraria; Roche: Honoraria; Takeda: Honoraria. Raab:Novartis: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding. Sonneveld:Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; BMS: Honoraria, Research Funding. Blau:Celgene: Other: Advisory board, Research Funding; Janssen: Other: Advisory board, Research Funding; Amgen: Other: Advisory board; Takeda: Other: Advisory board; Novartis: Other: Advisory boards; BMS: Other: Advisory board. Hillengass:Takeda: Honoraria, Other: Advisory Board; BMS: Honoraria, Other: Advisory Board; Celgene: Consultancy, Honoraria, Other: Advisory Board, Research Funding; amgen: Consultancy, Honoraria, Other: Advisory Board; Sanofi: Research Funding; Janssen: Honoraria, Other: Advisory Board; Novartis: Honoraria, Other: Advisory Board. Weisel:Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, Celgene, Janssen, and Sanofi: Research Funding; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees. Goldschmidt:Chugai: Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Takeda: Consultancy, Research Funding; Sanofi: Consultancy, Research Funding; Mundipharma: Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Adaptive Biotechnology: Consultancy; ArtTempi: Honoraria. Hose:Celgene: Honoraria, Research Funding; EngMab: Research Funding; Sanofi: Research Funding.
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- 2018
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244. Double Vs Single Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma: Long-Term Follow-up (10-Years) Analysis of Randomized Phase 3 Studies
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Cavo, Michele, Goldschmidt, Hartmut, Rosinol, Laura, Pantani, Lucia, Zweegman, Sonja, Salwender, Hans Jürgen, Lahuerta, Juan Jose, Lokhorst, Henk M., Petrucci, Maria Teresa, Blau, Igor, Oriol, Albert, Testoni, Nicoletta, Weisel, Katja, Rios, Rafael, Patriarca, Francesca, Blanchard, Jesús, Dozza, Luca, Mateos, Maria-Victoria, Galli, Monica, San-Miguel, Jesus F, Boccadoro, Mario, Blade, Joan, and Sonneveld, Pieter
- Abstract
Cavo: GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Goldschmidt:Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Adaptive Biotechnology: Consultancy; Sanofi: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Chugai: Honoraria, Research Funding; Mundipharma: Research Funding; Novartis: Honoraria, Research Funding; ArtTempi: Honoraria; Janssen: Consultancy, Honoraria, Research Funding. Rosinol:Janssen, Celgene, Amgen, Takeda: Honoraria. Zweegman:Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene Corp.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding. Salwender:Novartis: Honoraria, Other: travel suppport, Research Funding; Amgen: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding; Janssen: Honoraria, Other: travel support, Research Funding; Celgene: Honoraria, Other: travel suppport, Research Funding. Lahuerta:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Petrucci:Bristol-Myers Squibb: Honoraria, Other: Advisory Board; Takeda: Honoraria, Other: Advisory Board; Amgen: Honoraria, Other: Advisory Board; Celgene: Honoraria, Other: Advisory Board; Janssen-Cilag: Honoraria, Other: Advisory Board. Oriol:Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Weisel:Amgen, Celgene, Janssen, and Sanofi: Research Funding; Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees. Rios:Amgen, Celgene, Janssen, and Takeda: Consultancy. Patriarca:Celgene: Other: Advisory Role; Travel, accommodations, expenses; Medac: Other: Travel, accommodations, expenses; Jazz: Other: Travel, accommodations, expenses; Janssen: Other: Advisory role; MSD Italy: Other: Advisory Role. Mateos:GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Galli:Sigma-Tau: Honoraria; Celgene: Honoraria; Janssen: Honoraria; Bristol-Myers Squibb: Honoraria. San-Miguel:Novartis: Honoraria; Sanofi: Honoraria; Roche: Honoraria; BMS: Honoraria; Amgen: Honoraria; Janssen: Honoraria; Celgene: Honoraria. Boccadoro:Novartis: Honoraria, Research Funding; AbbVie: Honoraria; Janssen: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Mundipharma: Research Funding; Sanofi: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding. Blade:Janssen: Honoraria; Celgene: Honoraria; Amgen: Honoraria. Sonneveld:Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; BMS: Honoraria, Research Funding.
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- 2018
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245. Quantitative Integrative Prediction of Survival Probability in Multiple Myeloma Using Molecular and Clinical Prognostic Factors in 657 Patients Treated with Bortezomib-Based Induction, High-Dose Therapy and Autologous Stem Cell Transplantation
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Hummel, Manuela, Hielscher, Thomas, Salwender, Hans Jürgen, Scheid, Christof, Martin, Hans, Bertsch, Uta, Goldschmidt, Hartmut, Seckinger, Anja, and Hose, Dirk
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Salwender: Celgene: Honoraria, Other: travel suppport, Research Funding; Amgen: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Novartis: Honoraria, Other: travel suppport, Research Funding; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding; Janssen: Honoraria, Other: travel support, Research Funding. Scheid:Janssen: Honoraria; Celgene: Honoraria. Goldschmidt:ArtTempi: Honoraria; Chugai: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Takeda: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Mundipharma: Research Funding; Sanofi: Consultancy, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Adaptive Biotechnology: Consultancy. Seckinger:Celgene: Research Funding; EngMab: Research Funding; Sanofi: Research Funding. Hose:EngMab: Research Funding; Celgene: Honoraria, Research Funding; Sanofi: Research Funding.
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- 2018
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246. Salvage Autologous Transplant and Lenalidomide Maintenance Versus Continuous Lenalidomide/Dexamethasone for Relapsed Multiple Myeloma: Results of the Randomized GMMG Phase III Multicenter Trial Relapse
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Goldschmidt, Hartmut, Baertsch, Marc-A., Schlenzka, Jana, Becker, Natalia, Christina, Habermehl, Hielscher, Thomas, Raab, Marc S, Hillengass, Jens, Müller-Tidow, Carsten, Luntz, Steffen, Jauch, Anna, Brossart, Peter, Goerner, Martin, Klein, Stefan A, Schmidt-Hieber, Martin, Reimer, Peter, Graeven, Ullrich, Fenk, Roland, Haenel, Mathias, Martin, Hans, Lindemann, Hans-Walter, Scheid, Christoph, Nogai, Axel, Salwender, Hans Jürgen, Noppeney, Richard, and Weisel, Katja
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Goldschmidt: Amgen: Consultancy, Research Funding; Novartis: Honoraria, Research Funding; ArtTempi: Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Research Funding; Mundipharma: Research Funding; Takeda: Consultancy, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Adaptive Biotechnology: Consultancy; Chugai: Honoraria, Research Funding. Baertsch:Takeda: Consultancy; Novartis: Consultancy, Research Funding. Raab:Celgene: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding. Hillengass:Novartis: Honoraria, Other: Advisory Board; Sanofi: Research Funding; Takeda: Honoraria, Other: Advisory Board; Janssen: Honoraria, Other: Advisory Board; amgen: Consultancy, Honoraria, Other: Advisory Board; BMS: Honoraria, Other: Advisory Board; Celgene: Consultancy, Honoraria, Other: Advisory Board, Research Funding. Graeven:AbbVie: Honoraria; Roche: Membership on an entity's Board of Directors or advisory committees. Fenk:Takeda: Honoraria; Bristol-Meyers Squibb: Honoraria, Other: travel grant; Celgene: Honoraria, Other: Travel grant, Research Funding; Janssen: Honoraria; Amgen: Honoraria. Haenel:Novartis: Honoraria; Roche: Honoraria; Amgen: Honoraria; Takeda: Honoraria. Scheid:Novartis: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; Janssen: Honoraria; Celgene: Honoraria; BMS: Honoraria; Amgen: Honoraria. Salwender:Celgene: Honoraria, Other: travel suppport, Research Funding; Janssen: Honoraria, Other: travel support, Research Funding; Novartis: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Amgen: Honoraria, Other: travel suppport, Research Funding; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding. Weisel:Amgen, Celgene, Janssen, and Sanofi: Research Funding; Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees.
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- 2018
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247. Monitoring of FLT3 Phosphorylation and FLT3 Ligand Levels in Patients with FLT3-ITD Mutated Acute Myeloid Leukemia (AML) Treated with Midostaurin within the AMLSG 16-10 Trial of the German-Austrian Study Group
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Theis, Frauke, Weber, Daniela, Rücker, Frank G., Paschka, Peter, Gaidzik, Verena I., Thol, Felicitas, Heuser, Michael, Fiedler, Walter, Wulf, Gerald, Lübbert, Michael, Salih, Helmut R., Schroeder, Thomas Michael, Götze, Katharina S., Salwender, Hans Jürgen, Kindler, Thomas, Horst, Heinz-August, Ringhoffer, Mark, Wolf?, Dominik, Krauter, Jürgen, Schlenk, Richard F., Bullinger, Lars, Ganser, Arnold, Döhner, Hartmut, and Döhner, Konstanze
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Paschka: Astellas: Membership on an entity's Board of Directors or advisory committees, Travel support; Agios: Membership on an entity's Board of Directors or advisory committees; Sunesis: Membership on an entity's Board of Directors or advisory committees; Jazz: Speakers Bureau; Bristol-Meyers Squibb: Other: Travel support, Speakers Bureau; Pfizer: Membership on an entity's Board of Directors or advisory committees; Otsuka: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees, Other: Travel support, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Other: Travel support, Speakers Bureau; Astex: Membership on an entity's Board of Directors or advisory committees; Amgen: Other: Travel support; Janssen: Other: Travel support; Takeda: Other: Travel support. Fiedler:Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; ARIAD/Incyte: Membership on an entity's Board of Directors or advisory committees, support for meeting attendance; Novartis: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Patents & Royalties; Amgen: Research Funding; Pfizer: Research Funding; Amgen: Other: support for meetíng attendance; Gilead: Other: support for meeting attendance; GSO: Other: support for meeting attendance; Teva: Other: support for meeting attendance; JAZZ Pharmaceuticals: Other: support for meeting attendance; Daiichi Sankyo: Other: support for meeting attendance. Lübbert:Janssen: Honoraria, Research Funding; Celgene: Other: Travel Grant; Teva: Other: Study drug. Salih:Several patent applications: Patents & Royalties: e.g. EP3064507A1. Schroeder:Celgene: Consultancy, Honoraria, Research Funding. Götze:JAZZ Pharmaceuticals: Honoraria; Celgene: Honoraria, Research Funding; Takeda: Honoraria, Other: Travel aid ASH 2017; Novartis: Honoraria. Salwender:Amgen: Honoraria, Other: travel suppport, Research Funding; Novartis: Honoraria, Other: travel suppport, Research Funding; Celgene: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding; Janssen: Honoraria, Other: travel support, Research Funding. Schlenk:Pfizer: Research Funding, Speakers Bureau. Bullinger:Amgen: Honoraria, Speakers Bureau; Bristol-Myers Squibb: Speakers Bureau; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Research Funding, Speakers Bureau; Bayer Oncology: Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Speakers Bureau; Janssen: Speakers Bureau. Ganser:Novartis: Membership on an entity's Board of Directors or advisory committees. Döhner:Pfizer: Research Funding; Agios: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding; Astex Pharmaceuticals: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; AROG Pharmaceuticals: Research Funding; Pfizer: Research Funding; Bristol Myers Squibb: Research Funding; AbbVie: Consultancy, Honoraria; Astex Pharmaceuticals: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; AROG Pharmaceuticals: Research Funding; Astellas: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Astellas: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Research Funding; Jazz: Consultancy, Honoraria; Celator: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Celator: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Sunesis: Consultancy, Honoraria, Research Funding; Sunesis: Consultancy, Honoraria, Research Funding; Jazz: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Agios: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding.
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- 2018
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248. Subgroup Analyses of the Randomized GMMG Phase III Multicenter Trial Relapse Suggest Survival Benefit of Salvage Autologous Transplant Primarily in Low Risk Multiple Myeloma
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Baertsch, Marc-A., Schlenzka, Jana, Christina, Habermehl, Hielscher, Thomas, Raab, Marc S, Hillengass, Jens, Müller-Tidow, Carsten, Luntz, Steffen, Jauch, Anna, Brossart, Peter, Goerner, Martin, Klein, Stefan A, Schmidt-Hieber, Martin, Reimer, Peter, Graeven, Ullrich, Fenk, Roland, Haenel, Mathias, Martin, Hans, Lindemann, Hans-Walter, Scheid, Christoph, Nogai, Axel, Salwender, Hans Jürgen, Noppeney, Richard, Weisel, Katja, and Goldschmidt, Hartmut
- Abstract
IntroductionThe ReLApsE trial compared lenalidomide (LEN)/dexamethasone (DEX; Rd) re-induction, salvage high dose chemotherapy (HDCT), autologous stem cell transplantation (ASCT) and LEN maintenance with continuous Rd in relapsed multiple myeloma. Landmark (LM) analyses from salvage HDCT were performed due to the fact that ~30% of patients in the HDCT arm did not receive salvage HDCT/ASCT. These analyses showed a survival benefit in patients actually undergoing salvage HDCT/ASCT. Median PFS and OS from LM were 23.3 vs. 20.1 months (HR 0.74; p=0.09) and not reached vs. 57 months (HR 0.56; p=0.046) favoring the salvage HDCT/ASCT arm. Multivariate LM analyses showed significant associations of the salvage HDCT/ASCT arm with superior PFS (HR 0.6; p=0.01) and OS (HR 0.39; p=0.006). The present analysis aims to dissect treatment efficacy in relevant subgroups and provide clues for treatment stratification.
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- 2018
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249. Circulating Tumor Cells As a Surrogate Marker for Bone Marrow Minimal Residual Disease and an Adverse Prognostic Factor for Patients with Multiple Myelom
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Huhn, Stefanie, Hänel, Mathias, Hielscher, Thomas, Bertsch, Uta, Salwender, Hans Jürgen, Peter, Norma, Kirchner, Hartmut, Bernhard, Helga, Vogel, Martin, Angermund, Ralf, Goerner, Martin, Weisel, Katja C., Duering, Jan, Blau, Igor W, Weinhold, Niels, and Goldschmidt, Hartmut
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Introduction
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- 2017
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250. A Predictive Score for Early Mortality during Induction Therapy in Newly Diagnosed Transplant-Eligible Multiple Myeloma - an Analysis from Five GMMG and HOVON Multicenter Phase III Trials
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Mai, Elias K, Hielscher, Thomas, Bertsch, Uta, Schlenzka, Jana, Salwender, Hans Jürgen, Lokhorst, Henk M, Munder, Markus, van der Holt, Bronno, Gerecke, Christian, Pfreundschuh, Michael, Duhrsen, Ulrich, Brossart, Peter, Zweegman, Sonja, Neben, Kai, Hillengass, Jens, Raab, Marc-Steffen S, Hose, Dirk, Vellenga, Edo, Merz, Maximilian, Breitkreutz, Iris, Jauch, Anna, Kersten, Marie José, Martin, Hans, Lindemann, Hans-Walter, Peter, Norma, Croockewit, Sandra, Blau, Igor Wolfgang, Scheid, Christof, Weisel, Katja C., Sonneveld, Pieter, and Goldschmidt, Hartmut
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Introduction:Early mortality is up to 10% in newly diagnosed multiple myeloma (MM) with no improvement in subsequent study generations until 2002 (Augustson et al., JCO, 2005). Recent data on the causes of early mortality in transplant-eligible (te) MM patients during induction therapy (IT) and associated risk factors are not available.
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- 2017
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