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107 results on '"Salwender, Hans"'

1. CD8+ CD28− regulatory T cells after induction therapy predict progression-free survival in myeloma patients: results from the GMMG-HD6 multicenter phase III study

Author

Kriegsmann, Katharina, Ton, Gigi Nu Hoang Quy, Awwad, Mohamed H. S., Benner, Axel, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Fenk, Roland, Munder, Markus, Dürig, Jan, Blau, Igor W., Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Mann, Christoph, Weinhold, Niels, Scheid, Christof, Schroers, Roland, von Metzler, Ivana, Schieferdecker, Aneta, Thomalla, Jörg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe M., Kunz, Christian, Hensel, Manfred, Seidel-Glätzer, Andrea, Weisel, Katja C., Salwender, Hans J., Müller-Tidow, Carsten, Raab, Marc S., Goldschmidt, Hartmut, Mai, Elias K., and Hundemer, Michael

Published
2024
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3. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients

Author

Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Zweegman, Sonja, Raab, Marc S., Munder, Markus, Pantani, Lucia, Mancuso, Katia, Brossart, Peter, Beksac, Meral, Blau, Igor W., Dürig, Jan, Besemer, Britta, Fenk, Roland, Reimer, Peter, van der Holt, Bronno, Hänel, Mathias, von Metzler, Ivana, Graeven, Ullrich, Müller-Tidow, Carsten, Boccadoro, Mario, Scheid, Christof, Dimopoulos, Meletios A., Hillengass, Jens, Weisel, Katja C., Cavo, Michele, Sonneveld, Pieter, and Goldschmidt, Hartmut

Published
2024
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5. Elotuzumab, lenalidomide, bortezomib, dexamethasone, and autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GMMG-HD6): results from a randomised, phase 3 trial

Author

Adrian, Nicole, Bernhard, Helga, Böck, Hans-Peter, Bolling, Claus, Dingeldein, Gerrit, Emde, Till-Oliver, Ferstl, Barbara, Fietz, Thomas, Fronhoffs, Stefan, Fuhrmann, Stephan, Fuxius, Stefan, Geer, Thomas, Görner, Martin, Guenther, Barbara, Hartmann, Frank, Heilmeier, Bernhard, Heinsch, Michael, Hoffmann, Martin, Holderried, Tobias A.W., Klein, Stefan, Klump, Martin, Knauf, Wolfgang, La Rosée, Paul, Lange, Elisabeth, Lindemann, Walter, Lopez, Roderico, Mayer, Frank, Nückel, Holger, Papesch, Eva, Procaccianti, Maria, Reichart, Alexander, Rummel, Mathias, Scheuer, Lars, Schmitt, Hans-Roland, Staib, Peter, Steiniger, Heike, Tischler, Hans-Joachim, Ulshöfer, Thomas, Verbeek, Walter, Wacker, Alexander, Zirpel, Iris, Mai, Elias K, Goldschmidt, Hartmut, Miah, Kaya, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Krzykalla, Julia, Fenk, Roland, Schlenzka, Jana, Munder, Markus, Dürig, Jan, Blau, Igor W, Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Kunz, Christina, Mann, Christoph, Weinhold, Niels, Scheid, Christof, Schroers, Roland, von Metzler, Ivana, Schieferdecker, Aneta, Thomalla, Jörg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe M, Kunz, Christian, Hensel, Manfred, Benner, Axel, Seidel-Glätzer, Andrea, Weisel, Katja C, Raab, Marc S, and Salwender, Hans J

Published
2024
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6. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial

Author

Asemissen, Anne M, Behringer, Joachim, Bernhard, Helga, Bernhardt, Christiane, Bertsch, Uta, Besemer, Britta, Blau, Igor W, Bolling, Claus, Debatin, Daniel, Dingeldein, Gerrit, Dürig, Jan, Fenk, Roland, Ferstl, Barbara, Fest, Claudia, Fronhoffs, Stefan, Fuhrmann, Stephan, Gaska, Tobias, Geer, Thomas, Gezer, Deniz, Goldschmidt, Hartmut, Görner, Martin, Graeven, Ullrich, Grassinger, Jochen, Hänel, Mathias, Heilmeier, Bernhard, Heinsch, Michael, Held, Gerhard, Hoffmann, Martin, Holderried, Tobias A W, Hopfer, Olaf, Huhn, Stefanie, Immenschuh, Peter, Kaddu-Mulindwa, Dominic, Khandanpour, Cyrus, Klaiber-Hakimi, Maika, Klausmann, Martine, Klein, Stefan, Knauf, Wolfgang, Ko, Yon-Dschun, Köchling, Georg, Koenigsmann, Michael, Kostrewa, Philippe, Kraemer, Doris Maria, Kremers, Stephan, Kriegsmann, Katharina, Kropff, Martin, La Rosée, Paul, Luntz, Steffen P, Mahlberg, Rolf, Mai, Elias K, Mann, Christoph, Martens, Uwe, von Metzler, Ivana, Müller, Martin, Munder, Markus, Neise, Michael, Nievergall, Eva, Nückel, Holger, Pönisch, Wolfram, Procaccianti, Maria, Raab, Marc S, Rafiyan, Mohammed R, Reimer, Peter, Riecke, Armin, Riesenberg, Hendrik, Rummel, Mathias, Runde, Volker, Salwender, Hans J, Schaich, Markus, Scheid, Christoph, Schmidt-Hieber, Martin, Schmitt, Stefan, Schöndube, Daniel, Schroers, Roland, Schwarzer, Andreas, Staib, Peter, Steiniger, Heike, Sturmberg, Dirk, Thomalla, Jörg, Tichy, Diana, Tischler, Hans-Joachim, Trautmann-Grill, Karolin, Trummer, Arne, Tschechne, Barbara, Verbeek, Walter, Weinhold, Niels, Weisel, Katja C, Whitlock, Bettina, de Wit, Maike, Zaiß, Matthias, Ziske, Carsten, and Scheid, Christof

Published
2022
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7. Midostaurin plus intensive chemotherapy for younger and older patients with AML and FLT3 internal tandem duplications

Author

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

Published
2022
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8. Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial

Author

Leypoldt, Lisa B., Besemer, Britta, Asemissen, Anne Marie, Hänel, Mathias, Blau, Igor Wolfgang, Görner, Martin, Ko, Yon-Dschun, Reinhardt, Hans Christian, Staib, Peter, Mann, Christoph, Lutz, Raphael, Munder, Markus, Graeven, Ullrich, Peceny, Rudolf, Salwender, Hans, Jauch, Anna, Zago, Manola, Benner, Axel, Tichy, Diana, Bokemeyer, Carsten, Goldschmidt, Hartmut, and Weisel, Katja C.

Published
2022
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10. Quantitative Integrative Survival Prediction in Multiple Myeloma Patients Treated With Bortezomib-Based Induction, High-Dose Therapy and Autologous Stem Cell Transplantation.

Author

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
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]

Published
2024
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11. Long-term follow-up of subcutaneous versus intravenous bortezomib during induction therapy for newly diagnosed multiple myeloma treated within the GMMG-MM5 Phase III Trial

Author

Salwender, Hans, Elmaagacli, Ahmet, Merz, Maximilian, Miah, Kaya, Benner, Axel, Haenel, Mathias, Jehn, Christian, Mai, Elias K., Bertsch, Uta, Blau, Igor W., Scheid, Christof, Hose, Dirk, Seckinger, Anja, Jauch, Anna, Raab, Marc S., Luntz, Steffen P., Besemer, Britta, Munder, Markus, Brossart, Peter, Fuhrmann, Stephan, Lindemann, Hans-Walter, Weisel, Katja, Duerig, Jan, and Goldschmidt, Hartmut

Published
2021
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12. Selective elimination of immunosuppressive T cells in patients with multiple myeloma

Author

Awwad, Mohamed H. S., Mahmoud, Abdelrahman, Bruns, Heiko, Echchannaoui, Hakim, Kriegsmann, Katharina, Lutz, Raphael, Raab, Marc S., Bertsch, Uta, Munder, Markus, Jauch, Anna, Weisel, Katja, Maier, Bettina, Weinhold, Niels, Salwender, Hans Jürgen, Eckstein, Volker, Hänel, Mathias, Fenk, Roland, Dürig, Jan, Brors, Benedikt, Benner, Axel, Müller-Tidow, Carsten, Goldschmidt, Hartmut, and Hundemer, Michael

Published
2021
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13. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial

Author

Alegre Amor, Adrian, Baldini, Luca, Beksac, Meral, Belotti, Angelo, Benboubker, Lotfi, Besemer, Britta, Besisik, Sevgi, Bila, Jelena, Boccadoro, Mario, Cavo, Michele, De La Rubia Comos, Javier, Delimpasi, Sosana, Dimopoulos, Meletios A., Doyen, Chantal, Dytfeld, Dominik, Engelhardt, Monika, Facon, Thierry, Foà, Roberto, Goldschmidt, Hartmut, Grosicki, Sebastian, Hajek, Roman, Hayri Ozsan, Guner, Hulin, Cyrille, Iversen, Brian, Karlin, Lionel, Katodritou, Eirini, Knop, Stefan, Kyrtsonis, Marie-Christine, Lahuerta, Juan Jose, Leleu, Xavier, Martinez Chamorro, Carmen, Mateos Manteca, María-Victoria, Meuleman, Nathalie, Minnema, Monique, Moreau, Philippe, Offidani, Massino, Oriol Rocafiguera, Albert, Pehlivan, Mustafa, Pour, Ludek, Roerdink, Henk Th.J., Rosinol Dacsh, Laura, Salwender, Hans, Sonneveld, Pieter, Symeonidis, Anargyros, Toftmann Hansen, Charlotte, Tuglular, Tulin, Unal, Ali, Vlummens, Philip, Vural, Filiz, Wu, Ka Lung, Zweegman, Sonja, Dimopoulos, Meletios A, Terpos, Evangelos, Symeonidis, Argiris, Oriol, Albert, Mateos, Maria-Victoria, Einsele, Hermann, Orfanidis, Ioannis, Ahmadi, Tahamtan, Ukropec, Jon, Kampfenkel, Tobias, Schecter, Jordan M, Qiu, Yanping, Amin, Himal, Vermeulen, Jessica, and Carson, Robin

Published
2021
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14. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial

Author

Kumar, Shaji K, Harrison, Simon J, Cavo, Michele, de la Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina, Hungria, Vania, Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Punnoose, Elizabeth A, Hong, Wan-Jen, Freise, Kevin J, Yang, Xiaoqing, Sood, Anjla, Jalaluddin, Muhammad, Ross, Jeremy A, Ward, James E, Maciag, Paulo C, and Moreau, Philippe

Published
2020
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16. Molecular Long-Term Analysis of the GMMG-HD4 Trial in Multiple Myeloma—Patterns of Association of Chromosomal Aberrations with Response and Proliferation Determining Survival in Selecting Treatments in View of Limited Resources in Low- and Middle-Income Countries

Author

Seckinger, Anja, Salwender, Hans, Martin, Hans, Scheid, Christof, Hielscher, Thomas, Bertsch, Uta, Hummel, Manuela, Jauch, Anna, Knauf, Wolfgang, Emde-Rajaratnam, Martina, Beck, Susanne, Neben, Kai, Dührig, Jan, Lindemann, Walter, Schmidt-Wolf, Ingo G. H., Hänel, Mathias, Blau, Igor W., Weisel, Katja, Weinhold, Niels, and Raab, Marc S.

Subjects
*CHROMOSOME abnormalities, *MIDDLE-income countries, *MULTIPLE myeloma, *FLUORESCENCE in situ hybridization, *OVERALL survival
Abstract

Based on the lack of differences in progression-free and overall survival after a median follow-up of 93 months in our HOVON-65/GMMG-HD4 trial (German part; n = 395) randomizing VAD induction (vincristin/adriamycin/dexamthasone)/tandem-transplantation/thalidomide-maintenance vs. PAD induction (bortezomib/adriamycin/dexamethasone)/tandem transplantation/bortezomib maintenance, we discern how chromosomal aberrations determine long-term prognosis by different patterns of association with proliferation and treatment-dependent response, whether responses achieved by different regimens are equal regarding prognosis, and whether subpopulations of patients could be defined as treatable without upfront "novel agents" in cases of limited resources, e.g., in low- or middle-income countries. Serum parameters and risk factors were assessed in 395 patients. CD138-purified plasma cells were subjected to fluorescence in situ hybridization (n = 354) and gene expression profiling (n = 204). We found chromosomal aberrations to be associated in four patterns with survival, proliferation, and response: deletion (del) del17p13, del8p21, del13q14, (gain) 1q21+, and translocation t(4;14) (all adverse) associate with higher proliferation. Of these, del17p is associated with an adverse response (pattern 1), and 1q21+, t(4;14), and del13q14 with a treatment-dependent better response (pattern 2). Hyperdiploidy associates with lower proliferation without impacting response or survival (pattern 3). Translocation t(11;14) has no association with survival but a treatment-dependent adverse response (pattern 4). Significantly fewer patients reach a near-complete response or better with "conventional" (VAD) vs. bortezomib-based treatment after induction or high-dose melphalan. These patients, however, show significantly better median progression-free and overall survival. Molecularly, patients responding to the two regimens differ in gene expression, indicating distinct biological properties of the responding myeloma cells. Patients with normal renal function (89.4%), low cytogenetic risk (72.5%), or low proliferation rate (37.9%) neither benefit in progression-free nor overall survival from bortezomib-based upfront treatment. We conclude that response level, the treatment by which it is achieved, and molecular background determine long-term prognosis. Chromosomal aberrations are associated in four patterns with proliferation and treatment-dependent responses. Associations with faster and deeper responses can be deceptive in the case of prognostically adverse aberrations 1q21+ and t(4;14). Far from advocating a return to "outdated" treatments, if resources do not permit state-of-the-art-treatment, normal renal function and/or molecular profiling identifies patient subpopulations doing well without upfront "novel agents". [ABSTRACT FROM AUTHOR]

Published
2024
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17. Midostaurin added to chemotherapy and continued single-agent maintenance therapy in acute myeloid leukemia with FLT3-ITD

Author

Schlenk, Richard F., Weber, Daniela, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Kindler, Thomas, Lübbert, Michael, Wolf, Dominik, Westermann, Jörg, Kraemer, Doris, Götze, Katharina S., Horst, Heinz-August, Krauter, Jürgen, Girschikofsky, Michael, Ringhoffer, Mark, Südhoff, Thomas, Held, Gerhard, Derigs, Hans-Günter, Schroers, Roland, Greil, Richard, Grießhammer, Martin, Lange, Elisabeth, Burchardt, Alexander, Martens, Uwe, Hertenstein, Bernd, Marretta, Lore, Heuser, Michael, Thol, Felicitas, Gaidzik, Verena I., Herr, Wolfgang, Krzykalla, Julia, Benner, Axel, Döhner, Konstanze, Ganser, Arnold, Paschka, Peter, and Döhner, Hartmut

Published
2019
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18. Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study

Author

Bekadja, Mohamed, Hamladji, Rose-Marie, Ali, Hocine Ait, Hamdi, Selma, Touhami, Hadj, Mansour, Nourredine Sidi, Willenbacher, Wolfgang, Linkesch, Werner, Nemet, Damir, Pedersen, Robert Shou, Abildgaard, Niels, Laane, Edward, Hein, Marju, Mohty, Mohamad, Eveillard, Jean Richard, Yamani, Abderrazak el, Moreau, Philippe, Sanhes, Laurence, Lepeu, Gérard, Laribi, Kamel, Jourdan, Eric, Fitoussi, Olivier, Allangba, Olivier, Fleury, Joël, Escoffre, Martine, Benramdane, Riad, Cartron, Guillaume, Dine, Gérard, Legouffe, Eric, Harich, Hanns-Detlev, Illmer, Thomas, Dörfel, Steffen, Hannig, Carla Verena, Koenigsmann, Michael, Prange-Krex, Gabriele, Salwender, Hans, Tamm, Ingo, Zeller, Wolfgang, Maasberg, Michael, Schlag, Rudolf, Klausmann, Martine, Uhlig, Jens, Alkemper, Burkhard, Schütz, Stefan, Tessen, Hans-Werner, Mohr, Benno, Schmidt, Peter, Heinrich, Bernhard, Hebart, Holger, Seipelt, Gernot, Zoeller, Thomas, Heits, Frank, Müller-Naendrup, Clemens, Hansen, Richard, Repp, Roland, Von Weikersthal, Ludwig Fischer, Schmits, Rudolf, Heßling, Jörg, Krammer-Steiner, B., Janzen, Viktor, Schauer, Michael, Grüner, Marcus W., Kisro, Jens, Denzlinger, Claudio, Freier, Werner, Junghanss, Christian, Görner, Martin, Laichinger, Katharina, Ostermann, Helmut, Dürk, Heinz, Hess, Georg, Reich, Gernot, Terpos, Evangelos, Dimopoulos, Meletios, Matsouka, Panagiota, Pouli, Anastasia, Anagnostopoulos, Achilles, Masszi, Tamas, Borbényi, Zita, Ivanyi, Janos, Szomor, Arpad, Abadi, Uri, Nagler, Arnon, Magen, Hila, Avivi, Irit, Quitt, Miriam, Palumbo, Antonio, Boccadoro, Mario, De Stefano, Valerio, Za, Tommaso, Vallisa, Daniele, Foa, Roberto, Corso, Alessandro, Bosi, Alberto, Vacca, Angelo, Lanza, Francesco, Palazzo, Giulia, Avvisati, Giuseppe, Cavo, Michele, Ferrara, Felicetto, Consoli, Ugo, Cantonetti, Maria, Angelucci, Emanuele, Califano, Catello, Di Raimondo, Francesco, Guarini, Attilio, Musso, Maurizio, Pizzuti, Michele, Giuliani, Nicola, Ardizzoia, Antonio, Di Renzo, Nicola, Gaidano, Gianluca, Gozzetti, Alessandro, Pitini, Vincenzo, Farina, Gabriella, Centurioni, Riccardo, De Fabritiis, Paolo, Iuliano, Francesco, La Nasa, Giorgio, La Verde, Giacinto, Pane, Fabrizio, Recine, Umberto, La Targia, Maria, Mineo, Giuseppe, Cangialosi, Clotilde, Fagnani, Daniele, Federici, Augusto, Romano, Atelda, Specchia, Giorgina, Storti, Sergio, Bongarzoni, Velia, Bacigalupo, Andrea, Gobbi, Marco, Latte, Giancarlo, Mannina, Donato, Capalbo, Silvana, Lejniece, Sandra, Pečeliūnas, Valdas, Jurgutis, Mindaugas, Stankovic, Svetlana, Legiec, Wojciech, Woszczyk, Dariusz, Hołojda, Jadwiga, Gornik, Slawomir, Pluta, Andrzej, Morawiec-Szymonik, Elzbieta, Kyrcz-Krzemien, Slawomira, Homenda, Wojciech, Grosicki, Sebastian, Sulek, Kazimierz, Lange, Andrzej, Kloczko, Janusz, Starzak-Gwozdz, Jolanta, Hellmann, Andrzej, Komarnicki, Mieczyslaw, Kuliczkowski, Kazimierz, Viveiros, Carolina, Gonçalves, Cristina, Esefyeva, Natalia, Kochkareva, Julia, Kaplanov, Kamil, Volodicheva, Elena, Laricheva, Elena, Dergacheva, Valentina, Chukavina, Marina, Volchenko, Natalia, Nazarova, Irina, Anchukova, Ludmila, Ovanesova, Elena, Gritsenko, Taras, Salogub, Galina, Magomedova, Ludmila, Kuznetsova, Irina, Osyunikhina, Svetlana, Serdyuk, Olga, Karyagina, Elena, Ivanova, Valentina, Černelč, Slovenia Peter, Louw, Vernon, Coetzee, Corlia, Gunther, Karen, Moodley, Dhayanithi, Duran, Soledad, Gutiérrez, Asunción Echeveste, De Oteyza, Jaime Perez, Capote, Francisco Javier, Casanova, Maria, Sanchez, Jesus Martin, Rios-Herranz, Eduardo, Ibañez-Garcia, Jeronima, Herranz, Maria Jose, Hernandez, Belen, Sanchez, Sara Sanchez, Escalante, Fernando, Carnicero, Fernando, Lleonart, Joan Bargay, Gironella, Mercedes, Martínez, Rafael, De La Guia, Ana Lopez, Palomera, Luis, Iglesias, Rebeca, Ramos, Fernando Solano, De La Serna, Javier, Sanchez, Pedro Garcia, Vidal, Juan Besalduch, Mateos, Maria-Victoria, Morfa, Miguel Diaz, Beksac, Turkey – Meral, Vural, Filiz, Aydin, Yildiz, Unal, Ali, Goker, Hakan, Bilgir, Oktay, Guvenc, Birol, Turgut, Mehmet, Ozet, Gulsum Gulistan, Ali, Ridvan, Masliak, Zvenyslava, Kyselyova, Maryna, Glushko, Nataliia, Vybyrana, Renata, Skrypnyk, Igor, Tretyak, Natalya, Kharchevska, Tetiana, Dyagil, Iryna, Popovs'ka, Tetiana, Shimanskiy, Vadim, Lysa, Tamila, Oliynyk, Hanna, Vilchevskaya, Kateryna, Kryachok, Iryna, Popovych, Yuriy, Romanyuk, Natalia, Yushchenko, Natalia, Kaplan, Polina, Rekhtman, Grygoriy, Pylypenko, Halyna, Kozlov, Viktor, Drach, Johannes, Harousseau, Jean-Luc, Einsele, Hermann, Goldschmidt, Hartmut, Facon, Thierry, Michalet, Mauricette, Savchenko, Valery G., De la Rubia, Javier, Cook, Gordon, Mellqvist, Ulf-Henrik, Ludwig, Heinz, Beksac, Meral, Bekadja, Mohamed Amine, Durán, Maria Soledad, Kochkareva, Yulia, Berthou, Christian, Silva, João, Pedersen, Robert Schou, Černelč, Peter, Potamianou, Anna, Couturier, Catherine, Feys, Caroline, and Thoret-Bauchet, Florence

Published
2018
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19. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of High-Risk Newly Diagnosed Multiple Myeloma.

Author

Leypoldt, Lisa B., Tichy, Diana, Besemer, Britta, Hänel, Mathias, Raab, Marc S., Mann, Christoph, Munder, Markus, Reinhardt, Hans Christian, Nogai, Axel, Görner, Martin, Ko, Yon-Dschun, de Wit, Maike, Salwender, Hans, Scheid, Christof, Graeven, Ullrich, Peceny, Rudolf, Staib, Peter, Dieing, Annette, Einsele, Hermann, and Jauch, Anna

Published
2024
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20. RNA-sequencing based first choice of treatment and determination of risk in multiple myeloma.

Author

Emde-Rajaratnam, Martina, Beck, Susanne, Benes, Vladimir, Salwender, Hans, Bertsch, Uta, Scheid, Christoph, Hänel, Mathias, Weisel, Katja, Hielscher, Thomas, Raab, Marc S., Goldschmidt, Hartmut, Jauch, Anna, Maes, Ken, De Bruyne, Elke, Menu, Eline, De Veirman, Kim, Moreaux, Jéró me, Vanderkerken, Karin, Seckinger, Anja, and Hose, Dirk

Subjects
MULTIPLE myeloma, RNA sequencing, GENE expression profiling, STEM cell transplantation, DISEASE risk factors
Abstract

Background: Immunotherapeutic targets in multiple myeloma (MM) have variable expression height and are partly expressed in subfractions of patients only. With increasing numbers of available compounds, strategies for appropriate choice of targets (combinations) are warranted. Simultaneously, risk assessment is advisable as patient’s life expectancy varies between months and decades. Methods: We first assess feasibility of RNA-sequencing in a multicenter trial (GMMG-MM5, n=604 patients). Next, we use a clinical routine cohort of untreated symptomatic myeloma patients undergoing autologous stem cell transplantation (n=535, median follow-up (FU) 64 months) to perform RNAsequencing, gene expression profiling (GEP), and iFISH by ten-probe panel on CD138-purified malignant plasma cells. We subsequently compare target expression to plasma cell precursors, MGUS (n=59), asymptomatic (n=142) and relapsed (n=69) myeloma patients, myeloma cell lines (n=26), and between longitudinal samples (MM vs. relapsed MM). Data are validated using the independent MMRF CoMMpass-cohort (n=767, FU 31 months). Results: RNA-sequencing is feasible in 90.8% of patients (GMMG-MM5). Actionable immune-oncological targets (n=19) can be divided in those expressed in all normal and >99% of MM-patients (CD38, SLAMF7, BCMA, GPRC5D, FCRH5, TACI, CD74, CD44, CD37, CD79B), those with expression loss in subfractions of MM-patients (BAFF-R [81.3%], CD19 [57.9%], CD20 [82.8%],CD22 [28.4%]), aberrantly expressed in MM (NY-ESO1/2 [12%], MUC1 [12.7%], CD30 [4.9%], mutated BRAF V600E/K [2.1%]), and resistance-conveying targetmutations e.g., against part but not all BCMA-directed treatments. Risk is assessable regarding proliferation, translated GEP- (UAMS70-, SKY92-, RSscore) and de novo (LfM-HRS) defined risk scores. LfM-HRS delineates three groups of 40%, 38%, and 22% of patients with 5-year and 12-year survival rates of 84% (49%), 67% (18%), and 32% (0%). R-ISS and RNA-sequencing identify partially overlapping patient populations, with R-ISS missing, e.g., 30% (22/72) of highly proliferative myeloma. Conclusion: RNA-sequencing based assessment of risk and targets for first choice treatment is possible in clinical routine. [ABSTRACT FROM AUTHOR]

Published
2023
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22. Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma

Author

Salwender, Hans, Bertsch, Uta, Weisel, Katja, Duerig, Jan, Kunz, Christina, Benner, Axel, Blau, Igor W., Raab, Marc Steffen, Hillengass, Jens, Hose, Dirk, Huhn, Stefanie, Hundemer, Michael, Andrulis, Mindaugas, Jauch, Anna, Seidel-Glaetzer, Andrea, Lindemann, Hans-Walter, Hensel, Manfred, Fronhoffs, Stefan, Martens, Uwe, Hansen, Timon, Wattad, Mohammed, Graeven, Ullrich, Munder, Markus, Fenk, Roland, Haenel, Mathias, Scheid, Christof, and Goldschmidt, Hartmut

Published
2019
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23. Daratumumab, Bortezomib, and Dexamethasone for Treatment of Patients with Relapsed or Refractory Multiple Myeloma and Severe Renal Impairment: Results from the Phase 2 GMMG-DANTE Trial.

Author

Leypoldt, Lisa B., Gavriatopoulou, Maria, Besemer, Britta, Salwender, Hans, Raab, Marc S., Nogai, Axel, Khandanpour, Cyrus, Runde, Volker, Jauch, Anna, Zago, Manola, Martus, Peter, Goldschmidt, Hartmut, Bokemeyer, Carsten, Dimopoulos, Meletios A., and Weisel, Katja C.

Subjects
THERAPEUTIC use of monoclonal antibodies, KIDNEY disease risk factors, CLINICAL trials, DEXAMETHASONE, KIDNEY diseases, BORTEZOMIB, DISEASE relapse, SEVERITY of illness index, TREATMENT effectiveness, DESCRIPTIVE statistics, SURVIVAL analysis (Biometry), RESEARCH funding, MULTIPLE myeloma, PROGRESSION-free survival, DISEASE complications
Abstract

Simple Summary: Impaired kidney function is a common complication of a certain blood cancer called multiple myeloma. Patients with severe kidney problems are usually left out of medical studies, so data on safety and efficacy of treatments are limited for these patients. The academic phase II GMMG-DANTE trial (NCT02977494) investigated a combination of drugs—daratumumab, bortezomib, and dexamethasone—in patients who had already tried other treatments before, and had severe kidney impairment. Even though the study had to end early, the results were promising. About 67% of the patients had their cancer respond to the treatment, and their kidney function improved. The treatment was overall well tolerated. Renal function impairment (RI) is a common complication in multiple myeloma (MM). However, limited data exist on the safety and efficacy of anti-MM regimens in patients with severe RI, as these patients are frequently excluded from clinical trials. This investigator-initiated multicentric phase II GMMG-DANTE trial evaluated daratumumab, bortezomib, and dexamethasone (DVd) in relapsed or refractory (r/r) MM patients with severe RI. r/rMM patients with ≥1 prior treatment line and a GFR <30 mL/min/1.73 m2 or undergoing hemodialysis were eligible and received eight cycles of DVd followed by daratumumab maintenance. The trial closed prematurely after 22/36 planned patients. The primary endpoint was overall response rate (ORR). Median age of patients was 70 (range 55–89) years, with a median GFR of 20.1 mL/min/1.73 m2 (interquartile range, 9.4–27.3 mL/min/1.73 m2), and eight patients under hemodialysis. Median number of prior lines was two (range 1–10). The trial was successful, albeit with premature termination, as it met its primary endpoint, with an ORR of 67% (14/21). The rates of partial response, very good partial response, and complete response were 29%, 29%, and 10%, respectively (n = 6, 6, and 2). Fourteen patients (67%) achieved renal response. After median follow-up of 28 months, median progression-free survival was 10.4 months; median overall survival was not reached. Higher-grade toxicity was mainly hematologic, and non-hematologic toxicities ≥Grade 3 were mostly infections (24%). The prospective GMMG-DANTE trial investigating DVd exclusively in r/rMM patients with severe RI showed efficacy and safety to be comparable to data from patients without RI. [ABSTRACT FROM AUTHOR]

Published
2023
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24. Comparison of IGLV2‐14 light chain sequences of patients with AL amyloidosis or multiple myeloma.

Author

Berghaus, Natalie, Schreiner, Sarah, Poos, Alexandra M., Raab, Marc S., Goldschmidt, Hartmut, Mai, Elias K., Salwender, Hans‐Jürgen, Bernhard, Helga, Thurner, Lorenz, Müller‐Tidow, Carsten, Weinhold, Niels, Hegenbart, Ute, Schönland, Stefan O., and Huhn, Stefanie

Subjects
MULTIPLE myeloma, AMYLOIDOSIS, IMMUNOGLOBULIN light chains, ISOELECTRIC point
Abstract

Light chain amyloidosis (AL) is one of the most common forms of systemic amyloidosis and is caused by the deposition of insoluble fibrils derived from misfolded and aggregated immunoglobulin light chains (LC). To uncover the causes leading to this aggregation, we compared AL LC sequences with those of patients with the related disease multiple myeloma (MM), which do not aggregate in insoluble fibrils in vivo. IGLV2‐14 is one of the most common AL‐associated IGLV subfamilies. Here, we analysed IGLV2‐14 LC sequences of 13 AL and eight MM patients in detail. We found that AL‐associated LCs presented a lower median mutation count (7.0 vs. 11.5 in MM; P = 0.045), as well as an overall composition of less charged amino acids than MM LCs. However, we did not find a mutation that was present in ≥ 50% of the AL and not in the MM sequences. Furthermore, we did not find a significant difference in the isoelectric point (pI) in general, suggesting similar stability of the LCs in AL and MM. However, the subgroup of patients without a detectable heavy chain stood out. Surprisingly, they are characterized by an increase in mutation count (median 7.0 vs. 5.5) and pI (median 7.82 vs. 6.44, P = 0.043). In conclusion, our data suggest that the amount of mutations and the introduction of charges play a crucial role in AL fibril formation, as well as the absence or presence of a potential heavy chain binding partner. [ABSTRACT FROM AUTHOR]

Published
2023
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25. All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study

Author

Schlenk, Richard F., Lübbert, Michael, Benner, Axel, Lamparter, Alexander, Krauter, Jürgen, Herr, Wolfgang, Martin, Hans, Salih, Helmut R., Kündgen, Andrea, Horst, Heinz-A., Brossart, Peter, Götze, Katharina, Nachbaur, David, Wattad, Mohammed, Köhne, Claus-Henning, Fiedler, Walter, Bentz, Martin, Wulf, Gerald, Held, Gerhard, Hertenstein, Bernd, Salwender, Hans, Gaidzik, Verena I, Schlegelberger, Brigitte, Weber, Daniela, Döhner, Konstanze, Ganser, Arnold, Döhner, Hartmut, and for the German-Austrian Acute Myeloid Leukemia Study Group

Published
2016
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26. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial

Author

San-Miguel, Jesús F, Hungria, Vânia T M, Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios Athanasios, Elghandour, Ashraf, Jedrzejczak, Wieslaw Wiktor, Günther, Andreas, Nakorn, Thanyaphong Na, Siritanaratkul, Noppadol, Corradini, Paolo, Chuncharunee, Suporn, Lee, Je-Jung, Schlossman, Robert L, Shelekhova, Tatiana, Yong, Kwee, Tan, Daryl, Numbenjapon, Tontanai, Cavenagh, Jamie D, Hou, Jian, LeBlanc, Richard, Nahi, Hareth, Qiu, Lugui, Salwender, Hans, Pulini, Stefano, Moreau, Philippe, Warzocha, Krzysztof, White, Darrell, Bladé, Joan, Chen, WenMing, de la Rubia, Javier, Gimsing, Peter, Lonial, Sagar, Kaufman, Jonathan L, Ocio, Enrique M, Veskovski, Ljupco, Sohn, Sang Kyun, Wang, Ming-Chung, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Corrado, Claudia, Bengoudifa, Bourras-Rezki, Binlich, Florence, and Richardson, Paul G

Published
2014
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27. Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial

Author

Einsele, Hermann, Engelhardt, Monika, Tapprich, Christoph, Müller, Jürgen, Liebisch, Peter, Langer, Christian, Kropff, Martin, Mügge, Lars O., Jung, Wolfram, Wolf, Hans‐Heinrich, Metzner, Bernd, Hart, Christina, Gramatzki, Martin, Hertenstein, Bernd, Pfreundschuh, Michael, Rösler, Wolf, Fischer, Thomas, Maschmeyer, Georg, Kanz, Lothar, Hess, Georg, Jäger, Elke, Bentz, Martin, Dürk, Heinz A., Salwender, Hans, Hebart, Holger, Straka, Christian, and Knop, Stefan

Published
2017
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28. Panobinostat plus bortezomib and dexamethasone: impact of dose intensity and administration frequency on safety in the PANORAMA 1 trial

Author

San‐Miguel, Jesús F., Hungria, Vania T. M., Yoon, Sung‐Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Na Nakorn, Thanyaphong, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae‐Hoon, Einsele, Hermann, Salwender, Hans, Sopala, Monika, Redhu, Suman, Paul, Sofia, Corrado, Claudia, and Richardson, Paul G.

Published
2017
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29. Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS.

Author

Moreau, Philippe, Chari, Ajai, Oriol, Albert, Martinez-Lopez, Joaquin, Haenel, Mathias, Touzeau, Cyrille, Ailawadhi, Sikander, Besemer, Britta, de la Rubia Comos, Javier, Encinas, Cristina, Mateos, Maria-Victoria, Salwender, Hans, Rodriguez-Otero, Paula, Hulin, Cyrille, Karlin, Lionel, Sureda Balari, Anna, Bargay, Joan, Benboubker, Lotfi, Rosiñol, Laura, and Tarantolo, Stefano

Subjects
DARATUMUMAB, PLEIADES, MULTIPLE myeloma, HEART failure
Abstract

Patients in PLEIADES and EQUULEUS had received a median (range) of 1 (1-1) and 2 (1-4) prior lines of therapy, respectively, and 60 (90.9%) and 85 (100%) patients had received prior proteasome inhibitor therapy. EQUULEUS (NCT01998971) evaluated daratumumab IV plus weekly Kd (carfilzomib 70 mg/m SP 2 sp ; dexamethasone 40 mg) in RRMM patients after 1 to 3 prior lines of therapy (including bortezomib and an immunomodulatory drug). Patients in CANDOR received carfilzomib 56 mg/m SP 2 sp twice weekly (monthly cumulative dose, 336 mg/m SP 2 sp [Cycle 1, 264 mg/m SP 2 sp ]), while patients in PLEIADES and EQUULEUS received carfilzomib 70 mg/m SP 2 sp weekly (monthly cumulative dose, 210 mg/m SP 2 sp [Cycle 1, 160 mg/m SP 2 sp ]; ie, 62.5% of CANDOR monthly dose). [Extracted from the article]

Published
2023
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30. Testing G-CSF responsiveness predicts the individual susceptibility to infection and consecutive treatment in recipients of high-dose chemotherapy

Author

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

Published
2011
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31. Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project.

Author

D'Agostino, Mattia, Cairns, David A., Lahuerta, Juan José, Wester, Ruth, Bertsch, Uta, Waage, Anders, Zamagni, Elena, Mateos, María-Victoria, Dall'Olio, Daniele, van de Donk, Niels W.C.J., Jackson, Graham, Rocchi, Serena, Salwender, Hans, Bladé Creixenti, Joan, van der Holt, Bronno, Castellani, Gastone, Bonello, Francesca, Capra, Andrea, Mai, Elias K., and Dürig, Jan

Published
2022
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32. Treatment with Thalidomide and Cyclophosphamide (TCID) is Superior to Vincristine (VID) and to Vinorelbine (VRID) Regimens in Patients with Refractory or Recurrent Multiple Myeloma

Author

Auel, Britta, Goldschmidt, Hartmut, Geer, Thomas, Moehler, Thomas M., Platzbecker, Uwe, Naumann, Ralph, Blau, Igor, Hänel, Mathias, Knauf, Wolfgang, Nückel, Holger, Salwender, Hans-Jürgen, Scheid, Christof, Weisel, Katja, Gorschlüter, Marcus, Glasmacher, Axel, Schmidt-Wolf, Ingo G. H., and The German Refractory Myeloma Study Group

Published
2012
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35. 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)

Author

Bertz, Hartmut, Auner, Holger W., Weissinger, Florian, Salwender, Hans-Jürgen, Einsele, Hermann, Egerer, Gerlinde, Sandherr, Michael, Schüttrumpf, Silke, Südhoff, Thomas, and Maschmeyer, Georg

Published
2003
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36. 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)

Author

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

Published
2003
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38. 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)

Author

Weissinger, Florian, Auner, Holger W., Bertz, Hartmut, Buchheidt, Dieter, Cornely, Oliver A., Egerer, Gerlinde, Heinz, Werner, Karthaus, Meinolf, Kiehl, Michael, Krüger, William, Penack, Olaf, Reuter, Stefan, Ruhnke, Markus, Sandherr, Michael, Salwender, Hans-Jürgen, Ullmann, Andrew J., Waldschmidt, Dirk T., and Wolf, Hans H.

Published
2012
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39. Full or intensity‐reduced high‐dose melphalan and single or double autologous stem cell transplant with or without bortezomib consolidation in patients with newly diagnosed multiple myeloma.

Author

Straka, Christian, Salwender, Hans, Knop, Stefan, Vogel, Martin, Müller, Jürgen, Metzner, Bernd, Langer, Christian, Sayer, Herbert, Jung, Wolfram, Dürk, Heinz A., Bassermann, Florian, Gramatzki, Martin, Rösler, Wolf, Wolf, Hans‐Heinrich, Brugger, Wolfram, Engelhardt, Monika, Fischer, Thomas, Liebisch, Peter, and Einsele, Hermann

Subjects
*STEM cell transplantation, *MULTIPLE myeloma, *DIAGNOSIS, *BORTEZOMIB, *MELPHALAN
Abstract

Objective: A post hoc subgroup analysis of two phase III trials (NCT00416273, NCT00416208) was carried out to investigate the influence of 100/140 and 200 mg/m² melphalan as well as single/double autologous stem cell transplantation (ASCT) on progression‐free survival (PFS). Additionally, the effect of bortezomib consolidation on PFS was analyzed. Methods: Following induction therapy and high‐dose melphalan with subsequent ASCT, patients with newly diagnosed multiple myeloma (NDMM) were randomized 1:1 to either four 35‐day cycles of bortezomib consolidation (1.6 mg/m² IV on days 1, 8, 15, 22) or observation. Results: Of the 340 patients included in this analysis, 13.5% received 1 × MEL100/140, 22.9% 2 × MEL100/140, 31.2% 1 × MEL200, and 32.4% 2 × MEL200. With higher cumulative melphalan dose, PFS improved (P =.0085). PFS curves of patients treated with 2 × MEL100/140 and 1 × MEL200 were very similar. The superior dose effect of MEL200 over MEL100/140 was non‐existent in the bortezomib consolidation arm but pronounced in the observation arm (P =.0015). Similarly, double ASCT was only beneficial in patients without bortezomib consolidation (P =.0569). Conclusions: Full dose melphalan and double transplantation seem advantageous only as long as patients are not receiving bortezomib consolidation afterwards. [ABSTRACT FROM AUTHOR]

Published
2021
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42. Front-line daratumumab-VTd versus standard-of-care in ASCT-eligible multiple myeloma: matching-adjusted indirect comparison.

Author

Moreau, Philippe, Hebraud, Benjamin, Facon, Thierry, Leleu, Xavier, Hulin, Cyrille, Hashim, Mahmoud, Hu, Yannan, Caillot, Denis, Benboubker, Lofti, Zweegman, Sonja, Merz, Maximilian, Weisel, Katja, Salwender, Hans, Mai, Elias K, Goldschmidt, Hartmut, Bertsch, Uta, Vanquickelberghe, Véronique, Kampfenkel, Tobias, Boer, Carla de, and Krotneva, Stanimira

Published
2021
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43. Lenalidomide versus bortezomib maintenance after frontline autologous stem cell transplantation for multiple myeloma.

Author

Baertsch, Marc-Andrea, Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Munder, Markus, Fuhrmann, Stephan, Dührsen, Ulrich, Brossart, Peter, Neben, Kai, Schlenzka, Jana, Kunz, Christina, Raab, Marc S., Hillengaß, Jens, Jauch, Anna, Seckinger, Anja, Hose, Dirk, Luntz, Steffen, Sonneveld, Pieter, and Lokhorst, Henk

Subjects
BORTEZOMIB, ANTINEOPLASTIC agents, DRUG efficacy, MULTIPLE myeloma treatment, STEM cell transplantation, CANCER chemotherapy, CLINICAL trials
Abstract

Lenalidomide (LEN) maintenance (MT) post autologous stem cell transplantation (ASCT) is standard of care in newly diagnosed multiple myeloma (MM) but has not been compared to other agents in clinical trials. We retrospectively compared bortezomib (BTZ; n = 138) or LEN (n = 183) MT from two subsequent GMMG phase III trials. All patients received three cycles of BTZ-based triplet induction and post-ASCT MT. BTZ MT (1.3 mg/m2 i.v.) was administered every 2 weeks for 2 years. LEN MT included two consolidation cycles (25 mg p.o., days 1–21 of 28 day cycles) followed by 10–15 mg/day for 2 years. The BTZ cohort more frequently received tandem ASCT (91% vs. 33%) due to different tandem ASCT strategies. In the LEN and BTZ cohort, 43% and 46% of patients completed 2 years of MT as intended (p = 0.57). Progression-free survival (PFS; HR = 0.83, p = 0.18) and overall survival (OS; HR = 0.70, p = 0.15) did not differ significantly with LEN vs. BTZ MT. Patients with

Published
2021
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44. Autologous stem cell transplantation in multiple myeloma patients: utilization patterns and hospital effects.

Author

Jansen, Lina, Merz, Maximilian, Engelhardt, Monika, Weisel, Katja, Scheid, Christof, Straka, Christian, Langer, Christian, Salwender, Hans, Einsele, Hermann, Kröger, Nikolaus, Beelen, Dietrich W., Dreger, Peter, Goldschmidt, Hartmut, and Brenner, Hermann

Subjects
STEM cell transplantation, MULTIPLE myeloma, HOSPITAL utilization, CONFIDENCE intervals
Abstract

Evidence on volume outcome associations for autologous stem cell transplantation (ASCT) in multiple myeloma (MM) is limited. We investigated ASCT utilization patterns and volume outcome associations in the German National Registry for Stem Cell Transplants (DRST). MM patients with an upfront ASCT between 1998 and 2014 registered in the DRST were included. ASCT utilization increased strongly from 6% to 17% between 1999 and 2013 with the largest increase for patients aged 60–64 years (8–34%). The mean number of ASCTs conducted in the hospitals per year varied (quintiles, Q1:0.0–8.2 to Q5:31.0–102.7). Center volume was not associated with survival after upfront ASCT (lowest vs. highest center volume, hazard ratios and 95% confidence intervals: 0.95 (0.76–1.18), p = 0.92). Our findings may reflect a high standard of care and degree of specialization of centers performing ASCT for MM in Germany. [ABSTRACT FROM AUTHOR]

Published
2020
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45. Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials.

Author

Straka, Christian, Knop, Stefan, Vogel, Martin, Müller, Jürgen, Kropff, Martin, Metzner, Bernd, Langer, Christian, Sayer, Herbert, Jung, Wolfram, Dürk, Heinz A., Salwender, Hans, Wandt, Hannes, Bassermann, Florian, Gramatzki, Martin, Rösler, Wolf, Wolf, Hans‐Heinrich, Brugger, Wolfram, Fischer, Thomas, Liebisch, Peter, and Engelhardt, Monika

Subjects
AUTOGRAFTS, MULTIPLE myeloma, OLDER patients, BORTEZOMIB, PLASMACYTOMA, STEM cell transplantation
Abstract

Objective: A post hoc analysis of two phase III trials was carried out to explore the influence of age and treatment factors on the effect of bortezomib consolidation on progression‐free survival (PFS) post autologous stem cell transplantation (ASCT). Methods: Patients with newly diagnosed multiple myeloma were assigned to one of two trials (ClinicalTrials.gov IDs: NCT00416273, NCT00416208), which were conducted in parallel, based on age (18‐60 or 61‐75 years, respectively). Following induction and ASCT, patients were randomized 1:1 to four 35‐day cycles of bortezomib consolidation (1.6 mg/m2 IV on days 1, 8, 15, 22) or observation only. Results: Median PFS with bortezomib consolidation vs observation was 33.6 vs 29.0 months (P = 0.3599) in patients aged 18‐60 years (n = 202), and 33.4 vs 26.4 months (P = 0.0073) in patients aged 61‐75 years (n = 155), respectively. Bortezomib consolidation post‐ASCT appeared to equalize outcomes between older and younger patients who received prior treatment of differing intensity. This suggests that the effect of consolidation may be relative and may depend on the composition and intensity of induction and high‐dose therapy. Conclusion: Older patients receiving less intensive prior treatment could experience a larger PFS benefit from bortezomib consolidation. [ABSTRACT FROM AUTHOR]

Published
2019
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46. Treatment of relapsed refractory multiple myeloma: which new PI-based combination treatments do patients prefer?

Author

Wilke, Thomas, Mueller, Sabrina, Bauer, Sabine, Pitura, Silvia, Probst, Leona, Ratsch, Boris A, and Salwender, Hans

Subjects
MULTIPLE myeloma, CANCER chemotherapy, RANDOMIZED controlled trials, PATIENT compliance, CANCER treatment
Abstract

Background and objectives: This study describes preferences of German relapsed refractory multiple myeloma (RRMM) patients with novel proteasome inhibitor-based combination treatments.Methods: Patients with a minimum age of 18 years and a diagnosis of RRMM were included. Their preferences were assessed using a discrete choice experiment design, which was developed based on a literature review and two patient focus group discussions. The final discrete choice experiment design consisted of four attributes, namely "therapy application regimen," "time without progression of disease," "possibility of grade ≥3 adverse events (AEs) affecting the blood," and "possibility of grade ≥3 AE heart failure."Results: Analysis was based on 84 patients (36.9% females, mean age 62.7 years, mean multiple myeloma disease duration 5.5 years). Among the tested attributes, "therapy application regimen" was assigned the highest importance for treatment decisions (38.8%), the second important attribute was "time without progression of disease" (38.7%), followed by "possibility of AE heart failure" (13.9%) and "possibility of AEs affecting the blood" (8.6%). Patients preferred oral intake once a day and once a week over other application modes such as oral intake once a day and once a week plus twice-weekly infusions. Furthermore, they preferred longer disease progression-free time and lower risk of grade ≥3 AEs. The highest overall utility was derived for ixazomib + lenalidomide + dexamethasone (utility: 3.218), compared with lenalidomide + dexamethasone (2.769), and carfilzomib + lenalidomide + dexamethasone (1.928).Conclusion: RRMM patients prefer treatments with an all-oral application, a longer disease-progression-free time, and a lower probability of AEs. If patients face tradeoffs, they accept a lower progression-free time and/or higher AE rates to get an all-oral therapy. [ABSTRACT FROM AUTHOR]

Published
2018
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47. Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study.

Author

Mohty, Mohamad, Terpos, Evangelos, Mateos, Maria-Victoria, Cavo, Michele, Lejniece, Sandra, Beksac, Meral, Bekadja, Mohamed Amine, Legiec, Wojciech, Dimopoulos, Meletios, Stankovic, Svetlana, Durán, Maria Soledad, De Stefano, Valerio, Corso, Alessandro, Kochkareva, Yulia, Laane, Edward, Berthou, Christian, Salwender, Hans, Masliak, Zvenyslava, Pečeliūnas, Valdas, and Willenbacher, Wolfgang

Published
2018
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49. Cyclophosphamide-based stem cell mobilization in relapsed multiple myeloma patients: A subgroup analysis from the phase III trial Re LApsE.

Author

Baertsch, Marc‐Andrea, Schlenzka, Jana, Lisenko, Katharina, Krzykalla, Julia, Becker, Natalia, Weisel, Katja, Noppeney, Richard, Martin, Hans, Lindemann, Hans W., Haenel, Mathias, Nogai, Axel, Scheid, Christof, Salwender, Hans, Fenk, Roland, Graeven, Ullrich, Reimer, Peter, Schmidt‐Hieber, Martin, Goerner, Martin, Schmidt‐Wolf, Ingo G. H., and Klein, Stefan

Subjects
MULTIPLE myeloma treatment, STEM cells, CYCLOPHOSPHAMIDE, CANCER relapse, BONE marrow transplantation, CLINICAL trials
Abstract

Objective Analysis of the efficiency and toxicity of cyclophosphamide-based stem cell mobilization in patients with relapsed multiple myeloma ( RMM). Methods Peripheral blood stem cells ( PBSCs) were mobilized with high dose cyclophosphamide (2 g/m2 daily on days 1 and 2) and G- CSF plus pre-emptive/rescue plerixafor in RMM patients (first to third relapse) treated within the Re LApsE trial of the German-Speaking Myeloma Multicenter Group ( GMMG). Results Mobilization was initiated with high-dose cyclophosphamide (HD-CY) and G- CSF in 30 patients. Fifteen patients received additional pre-emptive/rescue administration of plerixafor. Stem cell collection was successful (≥2×106 CD34+ cells per kg bw) in 77% (23/30 patients). Patients with prior high-dose melphalan collected a significantly lower median total number of PBSCs than patients without prior high-dose melphalan (3.3×106 vs 17×106 CD34+ cells/kg bw). Toxicity of HD-CY was frequent with 12 serious adverse events ( SAE) in 37% of patients (11/30 patients). Infections accounted for the majority of SAE reports. In two patients, SAEs were lethal (septic shock). Conclusions These data proof feasibility of PBSC collection at relapse but emphasize the importance of collection and storage of additional PBSC transplants during first-line treatment when mobilization is more efficient and less toxic. [ABSTRACT FROM AUTHOR]

Published
2017
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50. Profound impact of sample processing delay on gene expression of multiple myeloma plasma cells.

Author

Meißner, Tobias, Seckinger, Anja, Hemminki, Kari, Bertsch, Uta, Foersti, Asta, Haenel, Mathias, Duering, Jan, Salwender, Hans, Goldschmidt, Hartmut, Morgan, Gareth J., Hose, Dirk, and Weinhold, Niels

Subjects
MULTIPLE myeloma, B cell lymphoma, GENE expression profiling, MOLECULAR genetics, PLASMA cells, GENETICS
Abstract

Background: Gene expression profiling (GEP) has significantly contributed to the elucidation of the molecular heterogeneity of multiple myeloma plasma cells (MMPC) and only recently it has been recommended for risk stratification. Prior to GEP MMPC need to be enriched resulting in an inability to immediately freeze bone marrow aspirates or use RNA stabilization reagents. As a result in multi-center MM trials sample processing delay due to shipping may be an important confounder of molecular analyses and risk stratification based on GEP data. Results: We compared GEP data of 145 in-house and 246 shipped samples and detected 3301 down-regulated and 3501 up-regulated genes in shipped samples. For 3994 genes we confirmed differential expression in an independent set of 85 in-house and 97 shipped samples. Differentially expressed genes were enriched in processes like ribosome biogenesis, cell cycle, and apoptosis. Among GEP based risk predictors the IFM-15 seemed to underestimate high risk in shipped samples, whereas the GEP70 and the EMC-92 gene signatures were more robust. In order to provide a tool to assess the "shipping effect" in public repositories, we generated a 17-gene predictor for shipped samples with a 10-fold cross validation error rate of 0.06 for the training set and an error rate of 0.15 for the validation set. Conclusion: Sample processing delay significantly influences GEP of MMPC, implying it should be avoided if samples were used for risk stratification. [ABSTRACT FROM AUTHOR]

Published
2015
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