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6. COVID-19 vaccination in patients with multiple myeloma: a consensus of the European Myeloma Network

Author

Ludwig, Heinz, Sonneveld, Pieter, Facon, Thierry, San-Miguel, Jesus, Avet-Loiseau, Hervé, Mohty, Mohamad, Mateos, Maria-Victoria, Moreau, Philippe, Cavo, Michele, Pawlyn, Charlotte, Zweegman, Sonja, Engelhardt, Monika, Driessen, Christoph, Cook, Gordon, Dimopoulos, Melitios A, Gay, Francesca, Einsele, Hermann, Delforge, Michel, Caers, Jo, Weisel, Katja, Jackson, Graham, Garderet, Laurent, van de Donk, Niels, Leleu, Xavier, Goldschmidt, Hartmut, Beksac, Meral, Nijhof, Inger, Schreder, Martin, Abildgaard, Niels, Hajek, Roman, Zojer, Niklas, Kastritis, Efstathios, Broijl, Annemiek, Schjesvold, Fredrik, Boccadoro, Mario, and Terpos, Evangelos

Published
2021
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7. Randomized comparison between KTd and KRd induction therapy followed by maintenance therapy with K or observation in transplant‐ineligible patients with newly diagnosed multiple myeloma

Author

Ludwig, Heinz, primary, Melchardt, Thomas, additional, Sormann, Siegfried, additional, Schreder, Martin, additional, Andel, Johannes, additional, Hartmann, Bernd, additional, Tinchon, Christoph, additional, Zojer, Niklas, additional, Gunsilius, Eberhard, additional, Podar, Klaus, additional, Egle, Alexander, additional, Willenbacher, Wolfgang, additional, Wöll, Ewald, additional, Ruckser, Reinhard, additional, Bozic, Boris, additional, Krauth, Maria‐Theresa, additional, Petzer, Andreas, additional, Schmitt, Clemens, additional, Machherndl‐Spandl, Sigrid, additional, Agis, Hermine, additional, Fillitz, Michael, additional, Wang, Song‐Yau, additional, Zabernigg, August, additional, Knop, Stefan, additional, Paiva, Bruno, additional, and Greil, Richard, additional

Published
2024
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8. Heterogeneous modulation of Bcl-2 family members and drug efflux mediate MCL-1 inhibitor resistance in multiple myeloma

Author

Bolomsky, Arnold, Miettinen, Juho J., Malyutina, Alina, Besse, Andrej, Huber, Julia, Fellinger, Stefanie, Breid, Helene, Parsons, Alun, Klavins, Kristaps, Hannich, J. Thomas, Kubicek, Stefan, Caers, Jo, Hübl, Wolfgang, Schreder, Martin, Zojer, Niklas, Driessen, Christoph, Tang, Jing, Besse, Lenka, Heckman, Caroline A., and Ludwig, Heinz

Published
2021
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11. QoL during KTd or KRd induction followed by K maintenance or observation in transplant noneligible patients with newly diagnosed multiple myeloma: Longitudinal and cross‐sectional analysis of the randomized AGMT 02 study.

Author

Ludwig, Heinz, Melchardt, Thomas, Schweitzer, Ilvy, Sormann, Siegfried, Schreder, Martin, Andel, Johannes, Hartmann, Bernd, Zojer, Niklas, Schöffmann, Laurenz, Gunsilius, Eberhard, Podar, Klaus, Egle, Alexander, Willenbacher, Wolfgang, Wöll, Ewald, Ruckser, Reinhard, Bozic, Boris, Krauth, Maria‐Theresa, Petzer, Andreas, Schmitt, Clemens, and Machherndl‐Spandl, Sigrid

Published
2024
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12. Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study

Author

Tremblay, Gabriel, Daniele, Patrick, Breeze, Janis, Li, Lingling, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Engelhardt, Monika, Chari, Ajaj, Nooka, Ajay, Vogl, Dan, Gavriatopoulou, Maria, Dimopoulos, Meletios-Athanasios, Richardson, Paul, Biran, Noa, Siegel, David, Vlummens, Philip, Doyen, Chantal, Facon, Thierry, Mohty, Mohamad, Meuleman, Nathalie, Levy, Moshe, Costa, Luciano, Hoffman, James E., Delforge, Michel, Kaminetzky, David, Weisel, Katja, Raab, Marc, Dingli, David, Tuchman, Sascha, Laurent, Frenzel, Vij, Ravi, Schiller, Gary, Moreau, Philippe, Richter, Joshua, Schreder, Martin, Podar, Klaus, Parker, Terri, Cornell, Robert Frank, Lionel, Karlin, Choquet, Sylvain, and Sundar, Jagannath

Published
2021
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13. Ixazomib–Thalidomide–Dexamethasone for induction therapy followed by Ixazomib maintenance treatment in patients with relapsed/refractory multiple myeloma

Author

Ludwig, Heinz, Poenisch, Wolfram, Knop, Stefan, Egle, Alexander, Schreder, Martin, Lechner, Daniel, Hajek, Roman, Gunsilius, Eberhard, Krenosz, Karl Jochen, Petzer, Andreas, Weisel, Katja, Niederwieser, Dietger, Einsele, Hermann, Willenbacher, Wolfgang, Melchardt, Thomas, Greil, Richard, and Zojer, Niklas

Published
2019
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15. Cox proportional hazards deep neural network identifies peripheral blood complete remission to be at least equivalent to morphologic complete remission in predicting outcomes of patients treated with azacitidine—A prospective cohort study by the AGMT

Author

Pleyer, Lisa, primary, Vaisband, Marc, additional, Drost, Manuel, additional, Pfeilstöcker, Michael, additional, Stauder, Reinhard, additional, Heibl, Sonja, additional, Sill, Heinz, additional, Girschikofsky, Michael, additional, Stampfl‐Mattersberger, Margarete, additional, Pichler, Angelika, additional, Hartmann, Bernd, additional, Petzer, Andreas, additional, Schreder, Martin, additional, Schmitt, Clemens A., additional, Vallet, Sonia, additional, Melchardt, Thomas, additional, Zebisch, Armin, additional, Pichler, Petra, additional, Zaborsky, Nadja, additional, Machherndl‐Spandl, Sigrid, additional, Wolf, Dominik, additional, Keil, Felix, additional, Hasenauer, Jan, additional, Larcher‐Senn, Julian, additional, and Greil, Richard, additional

Published
2023
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16. P943: OUTCOME ANALYSIS BY CYTOGENETIC RISK GROUP AFTER RANDOMIZATION TO KRD OR KTD FOLLOWED BY K MAINTENANCE OR CONTROL IN PATIENTS WITH NTE NDMM (AGMT MM-02)

Author

Ludwig, Heinz, primary, Melchardt, Thomas, additional, Sormann, Siegfried, additional, Schreder, Martin, additional, Andel, Johannes, additional, Hartmann, Bernd, additional, Tinchon, Christoph, additional, Zojer, Niklas, additional, Gunsilius, Eberhard, additional, Podar, Klaus, additional, Egle, Alexander, additional, Willenbacher, Wolfgang, additional, Woell, Ewald, additional, Ruckser, Reinhard, additional, Bozic, Boris, additional, Theresa Krauth, Maria, additional, Petzer, Andreas, additional, Schmitt, Clemens A., additional, Machherndl-Spandl, Sigrid, additional, Agis, Hermine, additional, Fillitz, Michael, additional, Wang, Song-Yau, additional, Knop, Stefan, additional, Paiva, Bruno, additional, and Greil, Richard, additional

Published
2023
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20. Allogeneic Hematopoietic Cell Transplantation in Multiple Myeloma: Focus on Longitudinal Assessment of Donor Chimerism, Extramedullary Disease, and High-Risk Cytogenetic Features

Author

Rasche, Leo, Röllig, Christoph, Stuhler, Gernot, Danhof, Sophia, Mielke, Stephan, Grigoleit, Goetz Ulrich, Dissen, Lea, Schemmel, Lea, Middeke, Jan Moritz, Rücker, Viktoria, Schreder, Martin, Schetelig, Johannes, Bornhäuser, Martin, Einsele, Hermann, Thiede, Christian, and Knop, Stefan

Published
2016
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22. Health-Related Quality of Life as Assessed by the EQ-5D-5L Predicts Outcomes of Patients Treated with Azacitidine—A Prospective Cohort Study by the AGMT

Author

Pleyer, Lisa, primary, Heibl, Sonja, additional, Tinchon, Christoph, additional, Vallet, Sonia, additional, Schreder, Martin, additional, Melchardt, Thomas, additional, Stute, Norbert, additional, Föhrenbach Quiroz, Kim Tamara, additional, Leisch, Michael, additional, Egle, Alexander, additional, Scagnetti, Lukas, additional, Wolf, Dominik, additional, Beswick, Richard, additional, Drost, Manuel, additional, Larcher-Senn, Julian, additional, Grochtdreis, Thomas, additional, Vaisband, Marc, additional, Hasenauer, Jan, additional, Zaborsky, Nadja, additional, Greil, Richard, additional, and Stauder, Reinhard, additional

Published
2023
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26. Randomized Comparison between Krd and Ktd Induction, Followed By K Maintenance or Control in Transplant Non-Eligible Patients with NDMM: Efficacy and Qol Data (AGMT-MM02 Trial)

Author

Ludwig, Heinz, primary, Melchardt, Thomas, additional, Sormann, Siegfried, additional, Zojer, Niklas, additional, Andel, Johannes, additional, Hartmann, Bernd L., additional, Tinchon, Christoph, additional, Gunsilius, Eberhard, additional, Podar, Klaus, additional, Egle, Alexander, additional, Willenbacher, Wolfgang, additional, Wöll, Ewald, additional, Schreder, Martin, additional, Ruckser, Reinhard, additional, Bozic, Boris, additional, Krauth, Maria-Theresa, additional, Petzer, Andreas, additional, Schmitt, Clemens A., additional, Machherndl-Spandl, Sigrid, additional, Agis, Hermine, additional, Fillitz, Michael, additional, Wang, Song-Yau, additional, Knop, Stefan, additional, Kainz, Sarah, additional, Paiva, Bruno, additional, and Greil, Richard, additional

Published
2022
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27. Cox Proportional Hazards Deep Neural Network Identifies Peripheral Blood Complete Remission (PB-CR) to be at Least Equivalent to Morphologic CR in Predicting Outcomes of Patients Treated with Azacitidine - a Prospective Cohort Study By the AGMT

Author

Pleyer, Lisa, primary, Vaisband, Marc, additional, Pfeilstocker, Michael, additional, Stauder, Reinhard, additional, Heibl, Sonja, additional, Sill, Heinz, additional, Girschikofsky, Michael, additional, Stampfl-Mattersberger, Margarete, additional, Tinchon, Christoph, additional, Hartmann, Bernd L., additional, Petzer, Andreas, additional, Schreder, Martin, additional, Schmitt, Clemens A., additional, Vallet, Sonia, additional, Melchardt, Thomas, additional, Scagnetti, Lukas, additional, Zebisch, Armin, additional, Machherndl-Spandl, Sigrid, additional, Wolf, Dominik, additional, Keil, Felix, additional, Hasenauer, Jan, additional, and Greil, Richard, additional

Published
2022
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30. Azacitidine in CMML: Matched-pair analyses of daily-life patients reveal modest effects on clinical course and survival

Author

Pleyer, Lisa, Germing, Ulrich, Sperr, Wolfgang R., Linkesch, Werner, Burgstaller, Sonja, Stauder, Reinhard, Girschikofsky, Michael, Schreder, Martin, Pfeilstocker, Michael, Lang, Alois, Sliwa, Thamer, Geissler, Dietmar, Schlick, Konstantin, Placher-Sorko, Gudrun, Theiler, Georg, Thaler, Josef, Mitrovic, Martina, Neureiter, Daniel, Valent, Peter, and Greil, Richard

Published
2014
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31. Adverse Events in 1406 Patients Receiving 13,780 Cycles of Azacitidine within the Austrian Registry of Hypomethylating Agents—A Prospective Cohort Study of the AGMT Study-Group

Author

Leisch, Michael, primary, Pfeilstöcker, Michael, additional, Stauder, Reinhard, additional, Heibl, Sonja, additional, Sill, Heinz, additional, Girschikofsky, Michael, additional, Stampfl-Mattersberger, Margarete, additional, Tinchon, Christoph, additional, Hartmann, Bernd, additional, Petzer, Andreas, additional, Schreder, Martin, additional, Kiesl, David, additional, Vallet, Sonia, additional, Egle, Alexander, additional, Melchardt, Thomas, additional, Piringer, Gudrun, additional, Zebisch, Armin, additional, Machherndl-Spandl, Sigrid, additional, Wolf, Dominik, additional, Keil, Felix, additional, Drost, Manuel, additional, Greil, Richard, additional, and Pleyer, Lisa, additional

Published
2022
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33. Azacitidine in 302 patients with WHO-defined acute myeloid leukemia: results from the Austrian Azacitidine Registry of the AGMT-Study Group

Author

Pleyer, Lisa, Burgstaller, Sonja, Girschikofsky, Michael, Linkesch, Werner, Stauder, Reinhard, Pfeilstocker, Michael, Schreder, Martin, Tinchon, Christoph, Sliwa, Thamer, Lang, Alois, Sperr, Wolfgang R., Krippl, Peter, Geissler, Dietmar, Voskova, Daniela, Schlick, Konstantin, Thaler, Josef, Machherndl-Spandl, Sigrid, Theiler, Georg, Eckmüllner, Otto, and Greil, Richard

Published
2014
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34. Composition of the Immune Environment at Baseline Correlates with Time to Response and Treatment Outcome in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (MM) Patients Randomized to Krd or Ktd Followed By Carfilzomib Maintenance or Observation (AGMT_MM 02 Study)

Author

Manrique, Irene, primary, Greil, Richard, additional, Andel, Johannes, additional, Sormann, Siegfried, additional, Hartmann, Bernd L., additional, Podar, Klaus, additional, Egle, Alexander, additional, Petzer, Andreas, additional, Zojer, Niklas, additional, Gunsilius, Eberhard, additional, Ruckser, Reinhard, additional, Bozic, Boris, additional, Schmitt, Clemens A., additional, Machherndl-Spandl, Sigrid, additional, Agis, Hermine, additional, Schreder, Martin, additional, Wang, Song-Yau, additional, Willenbacher, Wolfgang, additional, Krauth, Maria-Theresa, additional, Tinchon, Christoph, additional, Fillitz, Michael, additional, Melchardt, Thomas, additional, Knop, Stefan, additional, Paiva, Bruno, additional, and Ludwig, Heinz, additional

Published
2021
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36. The Agony of Choice—Where to Place the Wave of BCMA-Targeted Therapies in the Multiple Myeloma Treatment Puzzle in 2022 and Beyond

Author

Strassl, Irene, primary, Schreder, Martin, additional, Steiner, Normann, additional, Rudzki, Jakob, additional, Agis, Hermine, additional, Künz, Tina, additional, Müser, Nino, additional, Willenbacher, Wolfgang, additional, Petzer, Andreas, additional, Neumeister, Peter, additional, and Krauth, Maria Theresa, additional

Published
2021
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37. CTPS1 is a novel therapeutic target in multiple myeloma which synergizes with inhibition of CHEK1, ATR or WEE1

Author

Pfeiffer, Christina, Grandits, Alexander M., Asnagli, Hélène, Schneller, Anja, Huber, Julia, Zojer, Niklas, Schreder, Martin, Parker, Andrew E., Bolomsky, Arnold, Beer, Philip A., and Ludwig, Heinz

Abstract

Targeting nucleotide biosynthesis is a proven strategy for the treatment of cancer but is limited by toxicity, reflecting the fundamental nucleotide requirement of dividing cells. The rate limiting step in de novo pyrimidine synthesis is of interest, being catalyzed by two homologous enzymes, CTP synthase 1 (CTPS1) and CTPS2, that could be differentially targeted. Herein, analyses of publicly available datasets identified an essential role for CTPS1 in multiple myeloma (MM), linking high expression of CTPS1 (but not CTPS2) with advanced disease and poor outcomes. In cellular experiments, CTPS1knockout induced apoptosis of MM cell lines. Exposure of MM cells to STP-B, a novel and highly selective pharmacological inhibitor of CTPS1, inhibited proliferation, induced S phase arrest and led to cell death by apoptosis. Mechanistically, CTPS1 inhibition by STP-B activated DNA damage response (DDR) pathways and induced double-strand DNA breaks which accumulated in early S phase. Combination of STP-B with pharmacological inhibitors of key components of the DDR pathway (ATR, CHEK1 or WEE1) resulted in synergistic growth inhibition and early apoptosis. Taken together, these findings identify CTPS1 as a promising new target in MM, either alone or in combination with DDR pathway inhibition.

Published
2023
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39. Comparison of Cytomegalovirus-Specific Immune Cell Response to Proteins versus Peptides Using an IFN-γ ELISpot Assay after Hematopoietic Stem Cell Transplantation

Author

Wolff, Daniel, Wagner-Drouet, Eva Maria, Teschner, Daniel, Wolschke, Christine, Schäfer-Eckart, Kerstin, Gärtner, Johannes, Mielke, Stephan, Schreder, Martin, Kobbe, Guido, Hilgendorf, Inken, Klein, Stefan, Verbeek, Mareike, Ditschkowski, Markus, Koch, Martina, Lindemann, Monika, Schmidt, Traudel, Rascle, Anne, Barabas, Sascha, Deml, Ludwig, and Wagner, Ralf

Subjects
ddc:610, lcsh:R5-920, immune monitoring, immunosuppression, 610 Medizin, Medizin, CMV, T cells, CMV-specific cellular immunity, hematopoietic stem cell transplantation, recall antigen, peptide, IFN-γ ELISpot, antigen processing and presentation, virus diseases, Article, lcsh:Medicine (General)
Abstract

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality following hematopoietic stem cell transplantation (HSCT). Measuring CMV-specific cellular immunity may improve the risk stratification and management of patients. IFN-γ ELISpot assays, based on the stimulation of peripheral blood mononuclear cells with CMV pp65 and IE-1 proteins or peptides, have been validated in clinical settings. However, it remains unclear to which extend the T-cell response to synthetic peptides reflect that mediated by full-length proteins processed by antigen-presenting cells. We compared the stimulating ability of pp65 and IE-1 proteins and corresponding overlapping peptides in 16 HSCT recipients using a standardized IFN-γ ELISpot assay. Paired qualitative test results showed an overall 74.4% concordance. Discordant results were mainly due to low-response tests, with one exception. One patient with early CMV reactivation and graft-versus-host disease, sustained CMV DNAemia and high CD8+ counts showed successive negative protein-based ELISpot results but a high and sustained response to IE-1 peptides. Our results suggest that the response to exogenous proteins, which involves their uptake and processing by antigen-presenting cells, more closely reflects the physiological response to CMV infection, while the response to exogenous peptides may lead to artificial in vitro T-cell responses, especially in strongly immunosuppressed patients.

Published
2021

40. Additional file 1 of Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study

Author

Tremblay, Gabriel, Daniele, Patrick, Breeze, Janis, Li, Lingling, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Engelhardt, Monika, Chari, Ajaj, Nooka, Ajay, Vogl, Dan, Gavriatopoulou, Maria, Dimopoulos, Meletios-Athanasios, Richardson, Paul, Biran, Noa, Siegel, David, Vlummens, Philip, Doyen, Chantal, Facon, Thierry, Mohty, Mohamad, Meuleman, Nathalie, Levy, Moshe, Costa, Luciano, Hoffman, James E., Delforge, Michel, Kaminetzky, David, Weisel, Katja, Raab, Marc, Dingli, David, Tuchman, Sascha, Laurent, Frenzel, Vij, Ravi, Schiller, Gary, Moreau, Philippe, Richter, Joshua, Schreder, Martin, Podar, Klaus, Parker, Terri, Cornell, Robert Frank, Lionel, Karlin, Choquet, Sylvain, and Sundar, Jagannath

Abstract

Additional file 1 Table 1. Patients with improvement, no change, or decline in HRQoL based on minimal clinically important differences defined by ≥ 10% of the instrument range. Table 1 describes the number and proportion of patients with improvement, no change, or decline in HRQoL based on the minimal clinically important difference threshold defined as ≥10% of the instrument range. Data are shown for the FACT-MM, FACT-G, FACT-MM TOI, and the MM domain at treatment cycle 2–6 and end of treatment.

Published
2021
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41. Additional file 2 of Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study

Author

Tremblay, Gabriel, Daniele, Patrick, Breeze, Janis, Li, Lingling, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Engelhardt, Monika, Chari, Ajaj, Nooka, Ajay, Vogl, Dan, Gavriatopoulou, Maria, Dimopoulos, Meletios-Athanasios, Richardson, Paul, Biran, Noa, Siegel, David, Vlummens, Philip, Doyen, Chantal, Facon, Thierry, Mohty, Mohamad, Meuleman, Nathalie, Levy, Moshe, Costa, Luciano, Hoffman, James E., Delforge, Michel, Kaminetzky, David, Weisel, Katja, Raab, Marc, Dingli, David, Tuchman, Sascha, Laurent, Frenzel, Vij, Ravi, Schiller, Gary, Moreau, Philippe, Richter, Joshua, Schreder, Martin, Podar, Klaus, Parker, Terri, Cornell, Robert Frank, Lionel, Karlin, Choquet, Sylvain, and Sundar, Jagannath

Abstract

Additional file 2. Provides a list of IECs and IRBs for the STORM trial.

Published
2021
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42. Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study

Author

Tremblay, Gabriel Daniele, Patrick Breeze, Janis Li, Lingling Shah, Jatin Shacham, Sharon Kauffman, Michael and Engelhardt, Monika Chari, Ajaj Nooka, Ajay Vogl, Dan and Gavriatopoulou, Maria Dimopoulos, Meletios-Athanasios and Richardson, Paul Biran, Noa Siegel, David Vlummens, Philip and Doyen, Chantal Facon, Thierry Mohty, Mohamad Meuleman, Nathalie Levy, Moshe Costa, Luciano Hoffman, James E. and Delforge, Michel Kaminetzky, David Weisel, Katja Raab, Marc and Dingli, David Tuchman, Sascha Laurent, Frenzel Vij, Ravi and Schiller, Gary Moreau, Philippe Richter, Joshua and Schreder, Martin Podar, Klaus Parker, Terri Cornell, Robert Frank Lionel, Karlin Choquet, Sylvain Sundar, Jagannath

Abstract

Background: Selinexor is an oral, selective nuclear export inhibitor. STORM was a phase 2b, single-arm, open-label, multicenter trial of selinexor with low dose dexamethasone in patients with penta-exposed relapsed/refractory multiple myeloma (RRMM) that met its primary endpoint, with overall response of 26% (95% confidence interval [CI], 19 to 35%). Health-related quality of life (HRQoL) was a secondary endpoint measured using the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM). This study examines impact of selinexor treatment on HRQoL of patients treated in STORM and reports two approaches to calculate minimal clinically important differences for the FACT-MM. Methods: FACT-MM data were collected at baseline, on day 1 of each 4-week treatment cycle, and at end of treatment (EOT). Changes from baseline were analyzed for the FACT-MM total score, FACT-trial outcome index (TOI), FACT-General (FACT-G), and the MM-specific domain using mixed-effects regression models. Two approaches for evaluating minimal clinically important differences were explored: the first defined as 10% of the instrument range, and the second based on estimated mean baseline differences between Eastern Cooperative Oncology Group performance status (ECOG PS) scores. Post-hoc difference analysis compared change in scores from baseline to EOT for treatment responders and non-responders. Results: Eighty patients were included in the analysis; the mean number of prior therapies was 7.9 (standard deviation [SD] 3.1), and mean duration of myeloma was 7.6 years (SD 3.4). Each exploratory minimal clinically important difference threshold yielded consistent results whereby most patients did not experience HRQoL decline during the first six cycles of treatment (range: 53.9 to 75.7% for the first approach; range: 52.6 to 72.9% for the second). Treatment responders experienced less decline in HRQoL from baseline to EOT than non-responders, which was significant for the FACT-G, but not for other scores. Conclusion: The majority of patients did not experience decline in HRQoL based on minimal clinically important differences during early cycles of treatment with selinexor and dexamethasone in the STORM trial. An anchor-based approach utilizing patient-level data (ECOG PS score) to define minimal clinically important differences for the FACT-MM gave consistent results with a distribution-based approach.

Published
2021

43. COVID-19 vaccination in patients with multiple myeloma: a consensus of the European Myeloma Network

Author

Ludwig, Heinz Sonneveld, Pieter Facon, Thierry San-Miguel, Jesus Avet-Loiseau, Herve Mohty, Mohamad Mateos, Maria-Victoria Moreau, Philippe Cavo, Michele Pawlyn, Charlotte Zweegman, Sonja Engelhardt, Monika Driessen, Christoph Cook, Gordon Dimopoulos, Melitios A. Gay, Francesca Einsele, Hermann Delforge, Michel Caers, Jo and Weisel, Katja Jackson, Graham Garderet, Laurent van de Donk, Niels Leleu, Xavier Goldschmidt, Hartmut Beksac, Meral and Nijhof, Inger Schreder, Martin Abildgaard, Niels Hajek, Roman Zojer, Niklas Kastritis, Efstathios Broijl, Annemiek and Schjesvold, Fredrik Boccadoro, Mario Terpos, Evangelos

Abstract

Patients with multiple myeloma frequently present with substantial immune impairment and an increased risk for infections and infection-related mortality. The risk for infection with SARS-CoV-2 virus and resulting mortality is also increased, emphasising the importance of protecting patients by vaccination. Available data in patients with multiple myeloma suggest a suboptimal anti-SARS-CoV-2 immune response, meaning a proportion of patients are unprotected. Factors associated with poor response are uncontrolled disease, immunosuppression, concomitant therapy, more lines of therapy, and CD38 antibody-directed and B-cell maturation antigen-directed therapy. These facts suggest that monitoring the immune response to vaccination in patients with multiple myeloma might provide guidance for clinical management, such as administration of additional doses of the same or another vaccine, or even temporary treatment discontinuation, if possible. In those who do not exhibit a good response, prophylactic treatment with neutralising monoclonal antibody cocktails might be considered. In patients deficient of a SARS-CoV-2 immune response, adherence to measures for infection risk reduction is particularly recommended. This consensus was generated by members of the European Multiple Myeloma Network and some external experts. The panel members convened in virtual meetings and conducted an extensive literature research and evaluated recently published data and work presented at meetings, as well as findings from their own studies. The outcome of the discussions on establishing consensus recommendations for COVID-19 vaccination in patients with multiple myeloma was condensed into this Review.

Published
2021

46. Quality of Life in Newly Diagnosed Patients with Multiple Myeloma Randomized to Either Krd or Ktd Induction Therapy Followed By Carfilzomib Maintenance or Control (AGMT MM 02 trial)

Author

Ludwig, Heinz, Melchardt, Thomas, Andel, Johannes, Gunsilius, Eberhard, Sormann, Siegfried, Hinke, Axel, Hartmann, Bernd L., Podar, Klaus, Willenbacher, Wolfgang, Egle, Alexander, Petzer, Andreas, Zojer, Niklas, Wöll, Ewald, Ruckser, Reinhard, Bozic, Boris, Schmitt, Clemens A., Machherndl-Spandl, Sigrid, Krauth, Maria-Theresa, Schreder, Martin, Agis, Hermine, Tinchon, Christoph, Fillitz, Michael, and Greil, Richard

Published
2020
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47. Kinetics of Renal Function during Induction in Newly Diagnosed Multiple Myeloma: Results of Two Prospective Studies by the German Myeloma Study Group DSMM

Author

Bachmann, Friederike, primary, Schreder, Martin, additional, Engelhardt, Monika, additional, Langer, Christian, additional, Wolleschak, Denise, additional, Mügge, Lars Olof, additional, Dürk, Heinz, additional, Schäfer-Eckart, Kerstin, additional, Blau, Igor Wolfgang, additional, Gramatzki, Martin, additional, Liebisch, Peter, additional, Grube, Matthias, additional, v Metzler, Ivana, additional, Bassermann, Florian, additional, Metzner, Bernd, additional, Röllig, Christoph, additional, Hertenstein, Bernd, additional, Khandanpour, Cyrus, additional, Dechow, Tobias, additional, Hebart, Holger, additional, Jung, Wolfram, additional, Theurich, Sebastian, additional, Maschmeyer, Georg, additional, Salwender, Hans, additional, Hess, Georg, additional, Bittrich, Max, additional, Rasche, Leo, additional, Brioli, Annamaria, additional, Eckardt, Kai-Uwe, additional, Straka, Christian, additional, Held, Swantje, additional, Einsele, Hermann, additional, and Knop, Stefan, additional

Published
2021
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48. Comparison of Cytomegalovirus-Specific Immune Cell Response to Proteins versus Peptides Using an IFN-γ ELISpot Assay after Hematopoietic Stem Cell Transplantation

Author

Wagner-Drouet, Eva, primary, Teschner, Daniel, additional, Wolschke, Christine, additional, Schäfer-Eckart, Kerstin, additional, Gärtner, Johannes, additional, Mielke, Stephan, additional, Schreder, Martin, additional, Kobbe, Guido, additional, Hilgendorf, Inken, additional, Klein, Stefan, additional, Verbeek, Mareike, additional, Ditschkowski, Markus, additional, Koch, Martina, additional, Lindemann, Monika, additional, Schmidt, Traudel, additional, Rascle, Anne, additional, Barabas, Sascha, additional, Deml, Ludwig, additional, Wagner, Ralf, additional, and Wolff, Daniel, additional

Published
2021
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49. Reduced alpha diversity of the oral microbiome correlates with short progression‐free survival in patients with relapsed/refractory multiple myeloma treated with ixazomib‐based therapy (AGMT MM 1, phase II trial)

Author

Ludwig, Heinz, primary, Hausmann, Bela, additional, Schreder, Martin, additional, Pönisch, Wolfram, additional, Zojer, Niklas, additional, Knop, Stefan, additional, Gunsilius, Eberhard, additional, Egle, Alexander, additional, Petzer, Andreas, additional, Einsele, Hermann, additional, Hajek, Roman, additional, Weisel, Katja, additional, Krenosz, Karl Jochen, additional, Lang, Alois, additional, Lechner, Daniel, additional, Greil, Richard, additional, and Berry, David, additional

Published
2020
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50. Immunophenotyping of Baseline Bone Marrow Reveals a Specific Pattern of Immune Cells Associated with Greater Depth and Sustained Response in Newly Diagnosed Patients Randomized to Krd or Ktd Followed By Carfilzomib Maintenance or Control (AGMT MM 02 Study)

Author

Manrique, Irene, primary, Greil, Richard, additional, Andel, Johannes, additional, Sormann, Siegfried, additional, Hartmann, Bernd L., additional, Podar, Klaus, additional, Egle, Alexander, additional, Petzer, Andreas, additional, Zojer, Niklas, additional, Ruckser, Reinhard, additional, Bozic, Boris, additional, Schmitt, Clemens A., additional, Machherndl-Spandl, Sigrid, additional, Agis, Hermine, additional, Schreder, Martin, additional, Krauth, Maria-Theresa, additional, Tinchon, Christoph, additional, Fillitz, Michael, additional, Melchardt, Thomas, additional, Paiva, Bruno, additional, and Ludwig, Heinz, additional

Published
2020
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