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1. Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age

Author

Stephan Fuhrmann, Peter Brossart, Markus Munder, Mathias Hänel, Anja Seckinger, Katja Weisel, Hartmut Goldschmidt, Helga Bernhard, Jan Dürig, Anna Jauch, Martin Goerner, Christina Kunz, Hans-Walter Lindemann, Steffen Luntz, Ahmet H. Elmaagacli, Igor Wolfgang Blau, Hans Salwender, Maximilian Merz, Sandra Sauer, Marc S. Raab, Martin Hoffmann, Elias K. Mai, Kaya Miah, Axel Benner, Dirk Hose, Uta Bertsch, Christof Scheid, Hematology, and Basic (bio-) Medical Sciences

Subjects
Adult, Male, Melphalan, Cancer Research, medicine.medical_specialty, Multiple Myeloma/drug therapy, Medizin, Myeloma, Induction Chemotherapy/mortality, Article, Bortezomib, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Lenalidomide/administration & dosage, Humans, Medicine, Prospective Studies, Adverse effect, Lenalidomide, Multiple myeloma, Aged, Aged, 80 and over, business.industry, Correction, High dose melphalan, Consolidation Chemotherapy/mortality, Induction Chemotherapy, Hematology, Middle Aged, Prognosis, medicine.disease, Stem-cell research, Consolidation Chemotherapy, Survival Rate, Transplantation, Oncology, Toxicity, Randomized controlled trials, Bortezomib/administration & dosage, Female, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Multiple Myeloma, business, Follow-Up Studies, medicine.drug
Abstract

Intensive upfront therapy in newly-diagnosed multiple myeloma (MM) including induction therapy (IT), high-dose melphalan (MEL200), and autologous blood stem cell transplantation (ASCT) followed by consolidation and/or maintenance is mostly restricted to patients up to 65 years of age. Prospective phase III trial data in the era of novel agents for patients up to 70 years of age are not available. The GMMG-MM5 trial included 601 patients between 18 and 70 years of age, divided in three groups for the present analysis: ≤60 years (S1, n = 353), 61–65 years (S2, n = 107) and 66–70 years (S3, n = 141). Treatment consisted of a bortezomib-containing IT, MEL200/ASCT, consolidation, and maintenance with lenalidomide. Adherence to treatment was similar among patients of the three age groups. Overall toxicity during all treatment phases was increased in S2 and S3 compared to S1 (any adverse event/any serious adverse event: S1:81.7/41.8% vs. S2:90.7/56.5% vs. S3:87.2/68.1%, p = 0.05/p = 0.73), overall survival (log-rank p = 0.54) as well as time-to-progression (Gray’s p = 0.83) and non-relapse mortality (Gray’s p = 0.25), no differences were found between the three age groups. Our results imply that an intensive upfront therapy with a bortezomib-containing IT, MEL200/ASCT, lenalidomide consolidation, and maintenance should be applied to transplant-eligible MM patients up to 70 years of age.

Published
2020

2. Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial

Author

Martin Goerner, Markus Munder, Martin Hoffmann, Katja Weisel, Peter Brossart, Elias K. Mai, Anja Seckinger, Hans Salwender, Bernhard Rabold, Dirk Hose, Thomas Hielscher, Igor Wolfgang Blau, Uta Bertsch, Steffen Luntz, Ahmet H. Elmaagacli, Stefanie Huhn, Nicola Giesen, Hartmut Goldschmidt, Jens Hillengass, Marc S. Raab, Christina Kunz, Christof Scheid, Anna Jauch, Maximilian Merz, Diana Tichy, Barbara Hügle-Dörr, Hans-Walter Lindemann, Mathias Hänel, Helga Bernhard, Jan Dürig, Stephan Fuhrmann, Hematology, and Basic (bio-) Medical Sciences

Subjects
Male, 0301 basic medicine, Melphalan, Oncology, Cancer Research, Medizin, Dexamethasone, Cyclophosphamide/administration & dosage, Bortezomib, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Lenalidomide/administration & dosage, Medicine, Hematopoietic Stem Cell Transplantation/mortality, Prospective Studies, Lenalidomide, Multiple myeloma, education.field_of_study, Maintenance Chemotherapy/mortality, Remission Induction, Hazard ratio, Hematopoietic Stem Cell Transplantation, Hematology, Prognosis, Combined Modality Therapy, Thalidomide, Survival Rate, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, medicine.drug, Dexamethasone/administration & dosage, Melphalan/administration & dosage, medicine.medical_specialty, Population, Transplantation, Autologous, Maintenance Chemotherapy, 03 medical and health sciences, Internal medicine, Internal Medicine, Humans, education, Cyclophosphamide, Survival rate, Aged, Thalidomide/administration & dosage, business.industry, Consolidation Chemotherapy/mortality, medicine.disease, Multiple Myeloma/pathology, Consolidation Chemotherapy, Transplantation, 030104 developmental biology, Bortezomib/administration & dosage, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, business, Follow-Up Studies
Abstract

The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.

Published
2020

3. Bortezomib before and after high-dose therapy in myeloma

Author

Marian Stevens-Kroef, M. van Marwijk Kooy, Henk M. Lokhorst, Hans-Walter Lindemann, Anna Potamianou, Gerard M. J. Bos, B. van der Holt, Igor Wolfgang Blau, Annemiek Broijl, Christoph Scheid, Peter Brossart, Pieter Sonneveld, Sonja Zweegman, R. Schaafsma, Sandra Croockewit, Reinier Raymakers, Le Jarari, Ulrich Duehrsen, H Salwender, Jens Hillengass, Dirk Hose, Elias K. Mai, Anna Jauch, Marc-Steffen Raab, Michael Pfreundschuh, Thomas Hielscher, Paula F. Ypma, Marie-Jose Kersten, Katja Weisel, Edo Vellenga, H. Goldschmidt, Uta Bertsch, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Stem Cell Aging Leukemia and Lymphoma (SALL), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Hematologie (9), Hematology, CCA - Cancer immunology, CCA - Imaging, CCA - Biomarkers, CCA - Clinical Therapy Development, CCA - Evaluation of Cancer Care, CCA - Target Discovery & Preclinial Therapy Development, Anatomy and neurosciences, CCA - Cancer Treatment and Quality of Life, Clinical Haematology, AII - Amsterdam institute for Infection and Immunity, and AII - Inflammatory diseases

Subjects
Male, Melphalan, 2ND PRIMARY MALIGNANCIES, Cancer Research, DIAGNOSED MULTIPLE-MYELOMA, Medizin, PLUS DEXAMETHASONE, Bortezomib, 0302 clinical medicine, Autologous stem-cell transplantation, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14], Multiple myeloma, INTERGROUPE FRANCOPHONE, Hazard ratio, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, Prognosis, Progression-Free Survival, Thalidomide, Oncology, 030220 oncology & carcinogenesis, DEXAMETHASONE COMBINATION, DELETION 17P, Female, Multiple Myeloma, medicine.drug, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], Adult, medicine.medical_specialty, Adolescent, Urology, MAINTENANCE TREATMENT, Transplantation, Autologous, Young Adult, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, medicine, Humans, Progression-free survival, Aged, Chromosome Aberrations, business.industry, STEM-CELL TRANSPLANTATION, STAGING SYSTEM, medicine.disease, RANDOMIZED-TRIAL, Surgery, Transplantation, business, Follow-Up Studies, 030215 immunology
Abstract

The Dutch-Belgian Cooperative Trial Group for Hematology Oncology Group-65/German-speaking Myeloma Multicenter Group-HD4 (HOVON-65/GMMG-HD4) phase III trial compared bortezomib (BTZ) before and after high-dose melphalan and autologous stem cell transplantation (HDM, PAD arm) compared with classical cytotoxic agents prior and thalidomide after HDM (VAD arm) in multiple myeloma (MM) patients aged 18-65 years. Here, the long-term follow-up and data on second primary malignancies (SPM) are presented. After a median follow-up of 96 months, progression-free survival (censored at allogeneic transplantation, PFS) remained significantly prolonged in the PAD versus VAD arm (hazard ratio (HR) = 0.76, 95% confidence interval (95% CI) of 0.65-0.89, P = 0.001). Overall survival (OS) was similar in the PAD versus VAD arm (HR = 0.89, 95% CI: 0.74-1.08, P = 0.24). The incidence of SPM were similar between the two arms (7% each, P = 0.73). The negative prognostic effects of the cytogenetic aberration deletion 17p13 (clone size >= 10%) and renal impairment at baseline (serum creatinine > 2 mg dl(-1)) on PFS and OS remained abrogated in the PAD but not VAD arm. OS from first relapse/progression was similar between the study arms (HR = 1.02, P = 0.85). In conclusion, the survival benefit with BTZ induction/maintenance compared with classical cytotoxic agents and thalidomide maintenance is maintained without an increased risk of SPM.

Published
2018

4. Correction: High-risk additional chromosomal abnormalities at low blast counts herald death by CML

Author

S. Frühauf, R. Hansen, H. Munzinger, Urs Hess, X. Schiel, O. Stötzer, Holger Hebart, Mathias Hänel, S. Weidenhöfer, E. Jäger, H. Becker, Susanne Saußele, R. Gaeckler, F. Hartmann, Lorenz Trümper, W. Wuillemin, Thomas Illmer, W. Pommerien, Carlo Aul, P. le Coutre, W. Elsel, Otto Prümmer, A. Wehmeier, O. Klein, F. Schlegel, Sebastien Rinaldetti, D. Kingreen, Martin Bentz, J. Menzel, L. Hahn, R. Pihusch, Michael Schenk, Renate Arnold, Dietrich Kämpfe, B. Oldenkott, Alice Fabarius, M. Hahn, H. Eschenburg, A. Grote-Metke, M. Neise, Y. Dencausse, H. Köster, U. Vehling-Kaiser, M. Wattad, K. Stahlhut, H. Weischer, R. Moeller, Markus Pfirrmann, K. Neben, H. Tessen, A. Raghavachar, Peter Brossart, Hans-Heinrich Wolf, M. Hofknecht, Roland Schroers, Thomas Geer, Matthias Edinger, Axel R. Zander, R. Rudolph, F. Stegelmann, Winfried Gassmann, K. Ranft, A. Matzdorff, Christoph Scheid, M. Sosada, M. Sieber, G. Köchling, W. Fett, T. Herrmann, Rudolf Schlag, C. Maintz, S. Schanz, S. Hentschke, Peter Reichert, Dietrich W. Beelen, Alois Gratwohl, S. Schmitz, Michael Lauseker, Gabriela M. Baerlocher, H. P. Weidelich, F. Müller, B. Sievers, Alexander Kiani, J. Heßling, P. Majunke, W. Hollburg, D. Reschke, S. Wagner, B. Rendenbach, G. Käfer, W. Ludwig, Claudia Haferlach, A. Lochter, G. Baake, A. Schmalenbach, Y. Ko, R. Schwerdtfeger, Cornelius F. Waller, J. Mittermüller, Wolfgang E. Berdel, Walter Verbeek, C. Sperling, T. Fischer Huber, Karsten Spiekermann, C. Spohn, H. Pralle, Ch Scholz, C. Schelenz, H. Schick, A. D. Ho, Robert Dengler, C. Lunscken, D. Assman, H. Hoeffkes, A. Nusch, Hans-Walter Lindemann, B. Göttler, Günter Schlimok, H. Fiechtner, Patrick Wuchter, H. Forstbauer, C. Müller-Naendrup, J. Krauter, M. Planker, W. Langer, L. Schulz, Andreas Hochhaus, Hartmut Link, Philippe Schafhausen, Bernd Hertenstein, Andreas Neubauer, C. Schadeck-Gressel, M. Hoffknecht, L. Balleisen, A. Henzel, E. Ladda, Dieter K. Hossfeld, I. Blau, Jörg Hasford, V. Petersen, Christoph Nerl, M. Flaßhove, C. Lamberti, Stephan Kremers, Wassman, S. Korsten, Hans-Jochem Kolb, G. Adam, Michele Baccarani, M. Demandt, S. Al-Batran, S. Rösel, Jolanta Dengler, T. Neuhaus, Martin Griesshammer, B. Kempf, K. Josten, M. Sauer, W. Gröschel, U. Hieber, V. Runde, A. Urmersbach, Lutz P. Müller, Rüdiger Hehlmann, D. Linck, M. Hemeier, U. Martens, T. Kamp, S. Völkl, C. Diekmann, Andreas Burchert, T. Reiber, S. Bildat, J. Gmür, M. Uppenkamp, M. Simon, T. Zöller, Lothar Kanz, H. Strotkötter, N. Kalhori, R. Janz, Brigitte Schlegelberger, A. Hoyer, Wolfgang Seifarth, S. Stier, Katharina Kohlbrenner, J. Heymanns, J. Schleicher, Stefan W. Krause, M. de Wit, Antonio Pezzutto, D. Behringer, A. Lollert, H. Hitz, J. Janssen, G. Trenn, C. Lange, R. Depenbusch, A. Lindemann, H. Dietzfelbinger, B. Bechtel, B. Koch, B. Uebelmesser, U. Burkhardt, R. Fuchs, M. Schatz, S. Brettner, G. Heil, D. Hossfeld, Norbert Schmitz, C. Scheidegger, D. Reichert, M. Baldus, Michael J. Eckart, Axel A. Fauser, Lida Kalmanti, Birgit Spieß, Jiří Mayer, C. Ploger, C. A. Köhne, C. Priebe-Richter, C. Denzlinger, G. Doering, G. Springer, Tim H. Brümmendorf, Dominik Heim, Michael Kneba, I. M. Pfreundschuh, S. Jacki, M. Stauch, M. Kemmerling, Martin Wernli, A. Bartholomäus, Astghik Voskanyan, B. Sandritter, S. Fetscher, B. Goldmann, M. C. Goebler, C. Falge, Heinz Dürk, L. Fischer von Weikersthal, H. Baurmann, G. Ehninger, E. Schäfer, M. Schröder, F. Möller-Faßbender, K. Tajrobehkar, P. Schmidt, Christian A. Schmidt, A. Waladkhani, W. Freier, F. Henneke, and Beelen, Dietrich W. (Beitragende*r)

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Text mining, business.industry, Internal medicine, Medizin, medicine, MEDLINE, Hematology, business
Abstract

Korrektur zu 10.1038/s41375-020-0826-9

Published
2020

5. Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study

Author

Dietrich W. Beelen, Peter Staib, Gero Massenkeil, Heidrun Hindahl, Andreas Faldum, Karsten Spiekermann, Stefan K. Bohlander, Anja Baumgartner, Christian Buske, Michael Unterhalt, Marion Subklewe, Dennis Görlich, Michael Fiegl, Gerald Meckenstock, Cristina Sauerland, Xaver Schiel, Guido Trenn, E. Roemer, Harald Biersack, Dirk Medgenberg, Birgit Braess, Raphael Koch, Bettina Zinngrebe, Jan Braess, Rainer Schwerdtfeger, Maike de Wit, Hans Walter Lindemann, Karl-Anton Kreuzer, Eva Lengfelder, Michael Uppenkamp, Dirk Behringer, Wolfgang Hiddemann, Ullrich Graeven, Ernst Spaeth-Schwalbe, Tobias Gaska, Bernhard Wörmann, Michael G. Kiehl, Stephanie Schneider, Stefan Korsten, Wolf-Dieter Ludwig, Susanne Amler, Rudolf Peceny, Martin Lablans, Yon-Dschun Ko, and Annika Dufour

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Myeloid, Adolescent, Medizin, Phases of clinical research, Gastroenterology, Article, 03 medical and health sciences, Young Adult, 0302 clinical medicine, immune system diseases, Internal medicine, hemic and lymphatic diseases, mental disorders, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Aged, Aged, 80 and over, Mitoxantrone, Leukopenia, business.industry, Remission Induction, Cytarabine, Myeloid leukemia, food and beverages, virus diseases, Hematology, Middle Aged, medicine.disease, Regimen, Leukemia, Leukemia, Myeloid, Acute, medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, Female, medicine.symptom, business, 030215 immunology, medicine.drug
Abstract

Dose-dense induction with the S-HAM regimen was compared to standard double induction therapy in adult patients with newly diagnosed acute myeloid leukemia. Patients were centrally randomized (1:1) between S-HAM (2nd chemotherapy cycle starting on day 8 = “dose-dense”) and double induction with TAD-HAM or HAM(-HAM) (2nd cycle starting on day 21 = “standard”). 387 evaluable patients were randomly assigned to S-HAM (N = 203) and to standard double induction (N = 184). The primary endpoint overall response rate (ORR) consisting of complete remission (CR) and incomplete remission (CRi) was not significantly different (P = 0.202) between S-HAM (77%) and double induction (72%). The median overall survival was 35 months after S-HAM and 25 months after double induction (P = 0.323). Duration of critical leukopenia was significantly reduced after S-HAM (median 29 days) versus double induction (median 44 days)—P < 0.001. This translated into a significantly shortened duration of hospitalization after S-HAM (median 37 days) as compared to standard induction (median 49 days)—P < 0.001. In conclusion, dose-dense induction therapy with the S-HAM regimen shows favorable trends but no significant differences in ORR and OS compared to standard double induction. S-HAM significantly shortens critical leukopenia and the duration of hospitalization by 2 weeks.

Published
2018

6. Bortezomib-based induction therapy with high or low-dose dexamethasone in newly diagnosed, transplant-eligible multiple myeloma

Author

Thomas Hielscher, Christof Scheid, Anna Jauch, Markus Munder, Uta Bertsch, Peter Brossart, Elias K. Mai, Hans Martin, Katja Weisel, Hans Salwender, Dirk Hose, Marc-Andrea Baertsch, Marc S. Raab, Hartmut Goldschmidt, Jana Schlenzka, Christian Gerecke, Kai Neben, Maximilian Merz, Jens Hillengass, Hans-Walter Lindemann, Ulrich Dührsen, Igor Wolfgang Blau, Hematology, and Basic (bio-) Medical Sciences

Subjects
Oncology, Dexamethasone/administration & dosage, Male, Cancer Research, medicine.medical_specialty, Medizin, Dexamethasone, Bortezomib, 03 medical and health sciences, 0302 clinical medicine, Induction therapy, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Internal Medicine, Humans, Multiple Myeloma/diagnosis, Survival rate, Multiple myeloma, Aged, Retrospective Studies, business.industry, hematology, Low dose, Remission Induction, Retrospective cohort study, medicine.disease, Prognosis, Clinical trial, Survival Rate, 030220 oncology & carcinogenesis, oncology, Bortezomib/administration & dosage, Female, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, business, Multiple Myeloma, 030215 immunology, medicine.drug, Follow-Up Studies
Published
2018

7. Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma

Author

Anja Seckinger, Baerbel Schurich, Uta Bertsch, Ingo G.H. Schmidt-Wolf, Christina Kunz, Mathias Haenel, Dirk Hose, Jan Dürig, Markus Munder, Barbara Huegle-Doerr, Anna Jauch, Igor Wolfgang Blau, Hans Salwender, Christian Gerecke, Jens Hillengass, Maximilian Merz, Thomas Hielscher, Hans-Walter Lindemann, Marc-Steffen Raab, Elias K. Mai, H. Goldschmidt, Katja Weisel, Kai Neben, M. Zeis, and Christoph Scheid

Subjects
Adult, Male, endocrine system, Cancer Research, medicine.medical_specialty, Cyclophosphamide, Urology, Medizin, Neutropenia, Dexamethasone, Bortezomib, Leukocytopenia, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Prospective Studies, Survival rate, Multiple myeloma, Aged, Neoplasm Staging, business.industry, Remission Induction, Hematology, Induction Chemotherapy, Middle Aged, medicine.disease, Prognosis, Boronic Acids, Hematopoietic Stem Cell Mobilization, Surgery, Survival Rate, Oncology, Doxorubicin, Pyrazines, Female, business, Multiple Myeloma, Progressive disease, medicine.drug, Follow-Up Studies
Abstract

We aimed at demonstrating non-inferiority of bortezomib/cyclophosphamide/dexamethasone (VCD) compared to bortezomib/doxorubicin/dexamethasone (PAd) induction therapy with respect to very good partial response rates or better (⩾VGPR) in 504 newly diagnosed, transplant-eligible multiple myeloma patients. VCD was found to be non-inferior to PAd with respect to ⩾VGPR rates (37.0 versus 34.3%, P=0.001). The rates of progressive disease (PD) were 0.4% (VCD) versus 4.8% (PAd; P=0.003). In the PAd arm, 11 of 12 patients with PD had either renal impairment (creatinine ⩾2 mg/dl) at diagnosis or the cytogenetic abnormality gain 1q21, whereas no PD was observed in these subgroups in the VCD arm. Leukocytopenia/neutropenia (⩾3°) occurred more frequently in the VCD arm (35.2% versus 11.3%, P

Published
2014

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