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

Author

Mai, E K, Bertsch, U, Dürig, J, Kunz, C, Haenel, M, Blau, I W, Munder, M, Jauch, A, Schurich, B, Hielscher, T, Merz, M, Huegle-Doerr, B, Seckinger, A, Hose, D, Hillengass, J, Raab, M S, Neben, K, Lindemann, H-W, Zeis, M, Gerecke, C, Schmidt-Wolf, I G H, Weisel, K, Scheid, C, Salwender, H, and Goldschmidt, H

Published
2015
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3. P930: ISATUXIMAB, LENALIDOMIDE, BORTEZOMIB AND DEXAMETHASONE AS INDUCTION THERAPY FOR NEWLY-DIAGNOSED MULTIPLE MYELOMA PATIENTS WITH HIGH-RISK CYTOGENETICS: A SUBGROUP ANALYSIS FROM THE GMMG-HD7 TRIAL

Author

Mai, E. K., primary, Bertsch, U., additional, Fenk, R., additional, Tichy, D., additional, Besemer, B., additional, Dürig, J., additional, Schroers, R., additional, von Metzler, I., additional, Hänel, M., additional, Mann, C., additional, Asemissen, A. M., additional, Heilmeier, B., additional, Nievergall, E., additional, Huhn, S., additional, Kriegsmann, K., additional, Weinhold, N., additional, Luntz, S., additional, Holderrried, T. A. W., additional, Trautmann-Grill, K., additional, Gezer, D., additional, Klaiber-Hakimi, M., additional, Müller, M., additional, Khandanpour, C., additional, Knauf, W., additional, Scheid, C., additional, Munder, M., additional, Geer, T., additional, Riesenberg, H., additional, Thomalla, J., additional, Hoffmann, M., additional, Raab, M. S., additional, Salwender, H. J., additional, Weisel, K. C., additional, and Goldschmidt, H., additional

Published
2022
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4. P879: EXENT AND FLC MASS SPECTROMETRY FOR SEROLOGICAL IDENTIFICATION AND QUANTIFICATION OF MONOCLONAL IMMUNOGLOBULINS IN MULTIPLE MYELOMA

Author

Huhn, S., primary, Poos, A. M., additional, Mai, E. K., additional, Hänel, M., additional, Salwender, H. J., additional, Dürig, J., additional, Blau, I. W., additional, Scheid, C., additional, Weisel, K. C., additional, Munder, M., additional, Berlanga, O., additional, Bertsch, U., additional, Goldschmidt, H., additional, and Weinhold, N., additional

Published
2022
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6. Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMGHD-4 trial

Author

Goldschmidt, H., Lokhorst, H. M., Mai, E. K., van der Holt, B., Blau, I. W., Zweegman, S., Weisel, K. C., Vellenga, E., Pfreundschuh, M., Kersten, M. J., Scheid, C., Croockewit, S., Raymakers, R., Hose, D., Potamianou, A., Jauch, A., Hillengass, J., Stevens-Kroef, M., Raab, M. S., Broijl, A., Lindemann, H. W., Bos, G. M. J., Brossart, P., Kooy, M. van Marwijk, Ypma, P., Duehrsen, U., Schaafsma, R. M., Bertsch, U., Hielscher, T., Jarari, Le, Salwender, H. J., Sonneveld, P., Goldschmidt, H., Lokhorst, H. M., Mai, E. K., van der Holt, B., Blau, I. W., Zweegman, S., Weisel, K. C., Vellenga, E., Pfreundschuh, M., Kersten, M. J., Scheid, C., Croockewit, S., Raymakers, R., Hose, D., Potamianou, A., Jauch, A., Hillengass, J., Stevens-Kroef, M., Raab, M. S., Broijl, A., Lindemann, H. W., Bos, G. M. J., Brossart, P., Kooy, M. van Marwijk, Ypma, P., Duehrsen, U., Schaafsma, R. M., Bertsch, U., Hielscher, T., Jarari, Le, Salwender, H. J., and Sonneveld, P.

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

7. MAGNETIC RESONANCE IMAGING BEFORE AND AFTER UPFRONT AUTOLOGOUS TRANSPLANTATION IDENTIFIES PATIENTS WITH ADVERSE OUTCOME BUT RESPONSE TO TREATMENT WITHIN THE PROSPECTIVE GMMG MM5 PHASE III TRIAL

Author

Merz, M., Hielscher, T., Seckinger, A., Jauch, A., Mai, E. K., Bertsch, U., Raab, M. S., Neben, K., Salwender, H., Blau, I. W., Lindemann, H. W., Duerig, J., Scheid, C., Haenel, M., Weisel, K., Delorme, S., Kauczor, H. U., Hose, D., Goldschmidt, H., Hillengass, J., Merz, M., Hielscher, T., Seckinger, A., Jauch, A., Mai, E. K., Bertsch, U., Raab, M. S., Neben, K., Salwender, H., Blau, I. W., Lindemann, H. W., Duerig, J., Scheid, C., Haenel, M., Weisel, K., Delorme, S., Kauczor, H. U., Hose, D., Goldschmidt, H., and Hillengass, J.

Published
2018

8. Bortezomib before and after high-dose therapy in myeloma : long-term results from the phase III HOVON-65/GMMG-HD4 trial

Author

Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, Sonneveld, P, Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, and Sonneveld, P

Published
2018

9. Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial

Author

Externen Hematologie, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, Sonneveld, P, Externen Hematologie, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Goldschmidt, H, Lokhorst, H M, Mai, E K, van der Holt, B, Blau, I W, Zweegman, S, Weisel, K C, Vellenga, E, Pfreundschuh, M, Kersten, M J, Scheid, C, Croockewit, S, Raymakers, R, Hose, D, Potamianou, A, Jauch, A, Hillengass, J, Stevens-Kroef, M, Raab, M S, Broijl, A, Lindemann, H W, Bos, G M J, Brossart, P, van Marwijk Kooy, M, Ypma, P, Duehrsen, U, Schaafsma, R M, Bertsch, U, Hielscher, T, Jarari, Le, Salwender, H J, and Sonneveld, P

Published
2018

10. Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial

Author

Goldschmidt, H, primary, Lokhorst, H M, additional, Mai, E K, additional, van der Holt, B, additional, Blau, I W, additional, Zweegman, S, additional, Weisel, K C, additional, Vellenga, E, additional, Pfreundschuh, M, additional, Kersten, M J, additional, Scheid, C, additional, Croockewit, S, additional, Raymakers, R, additional, Hose, D, additional, Potamianou, A, additional, Jauch, A, additional, Hillengass, J, additional, Stevens-Kroef, M, additional, Raab, M S, additional, Broijl, A, additional, Lindemann, H W, additional, Bos, G M J, additional, Brossart, P, additional, van Marwijk Kooy, M, additional, Ypma, P, additional, Duehrsen, U, additional, Schaafsma, R M, additional, Bertsch, U, additional, Hielscher, T, additional, Jarari, Le, additional, Salwender, H J, additional, and Sonneveld, P, additional

Published
2017
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12. Prediction of early overall and infection-related mortality during induction therapy in transplant-eligible multiple myeloma - a pooled analysis from three GMMG phase III trials

Author

Mai, E. K., Hielscher, T., Bertsch, U., Schlenzka, J., Salwender, H. J., Munder, M., Gerecke, C., Pfreundschuh, M., Duehrsen, U., Brossart, P., Neben, K., Hillengass, J., Raab, M. S., Hose, D., Merz, M., Breitkreutz, I., Jauch, A., Martin, H., Lindemann, H. -W., Scheid, C., Weisel, K. C., Blau, I. W., Goldschmidt, H., Mai, E. K., Hielscher, T., Bertsch, U., Schlenzka, J., Salwender, H. J., Munder, M., Gerecke, C., Pfreundschuh, M., Duehrsen, U., Brossart, P., Neben, K., Hillengass, J., Raab, M. S., Hose, D., Merz, M., Breitkreutz, I., Jauch, A., Martin, H., Lindemann, H. -W., Scheid, C., Weisel, K. C., Blau, I. W., and Goldschmidt, H.

Published
2017

13. Peripheral neuropathy associated with subcutaneous or intravenous bortezomib in patients with newly diagnosed myeloma treated within the GMMG MM5 phase III trial

Author

Merz, M., primary, Salwender, H., additional, Haenel, M., additional, Mai, E. K., additional, Bertsch, U., additional, Kunz, C., additional, Hielscher, T., additional, Blau, I. W., additional, Scheid, C., additional, Hose, D., additional, Seckinger, A., additional, Jauch, A., additional, Hillengass, J., additional, Raab, M. S., additional, Schurich, B., additional, Munder, M., additional, Brossart, P., additional, Gerecke, C., additional, Lindemann, H.-W., additional, Zeis, M., additional, Weisel, K., additional, Duerig, J., additional, and Goldschmidt, H., additional

Published
2016
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14. Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma

Author

Mai, E. K., Bertsch, U., Duerig, J., Kunz, C., Haenel, M., Blau, I. W., Munder, M., Jauch, A., Schurich, B., Hielscher, T., Merz, M., Huegle-Doerr, B., Seckinger, A., Hose, D., Hillengass, J., Raab, M. S., Neben, K., Lindemann, H-W, Zeis, M., Gerecke, C., Schmidt-Wolf, I. G. H., Weisel, K., Scheid, C., Salwender, H., Goldschmidt, H., Mai, E. K., Bertsch, U., Duerig, J., Kunz, C., Haenel, M., Blau, I. W., Munder, M., Jauch, A., Schurich, B., Hielscher, T., Merz, M., Huegle-Doerr, B., Seckinger, A., Hose, D., Hillengass, J., Raab, M. S., Neben, K., Lindemann, H-W, Zeis, M., Gerecke, C., Schmidt-Wolf, I. G. H., Weisel, K., Scheid, C., Salwender, H., and Goldschmidt, H.

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 degrees) occurred more frequently in the VCD arm (35.2% versus 11.3%, P<0.001). Neuropathy rates (>= 2 degrees) were higher in the PAd group (14.9 versus 8.4%, P = 0.03). Serious adverse events, both overall and those related to thromboembolic events, were higher in the PAd group (32.7 versus 24.0%, P = 0.04 and 2.8 versus 0.4%, P = 0.04). Stem cell collection was not impeded by VCD. VCD is as effective as PAd in terms of achieving >= VGPR rates with fewer PD and has a favorable toxicity profile. Therefore, VCD is preferable to PAd as induction therapy.

Published
2015

15. Single versus tandem high-dose melphalan followed by autologous blood stem cell transplantation in newly-diagnosed multiple myeloma: final results from the GMMG-HD2 trial

Author

Mai, E. K., Benner, A., Bertsch, U., Schmidt-Wolf, I. G. H., Haenel, A., Kunzmann, V, Naumann, R., Neben, K., Egerer, G., Hillengass, J., Neubauer, A., Peyn, A., Ko, Y-D, Peter, N., Salwender, H. J., Scheid, C., Goldschmidt, H., Mai, E. K., Benner, A., Bertsch, U., Schmidt-Wolf, I. G. H., Haenel, A., Kunzmann, V, Naumann, R., Neben, K., Egerer, G., Hillengass, J., Neubauer, A., Peyn, A., Ko, Y-D, Peter, N., Salwender, H. J., Scheid, C., and Goldschmidt, H.

Published
2015

16. Comparative assessment of myeloma response to induction treatment in the GMMG MM5 study using IMWG criteria and hevylite assay

Author

Scheid, C., Hose, D., Bertsch, U., Hielscher, T., Kunz, C., Salwender, H., Haenel, M., Merz, M., Mai, E. K., Schurich, B., Munder, M., Schmidt-Wolf, I, Gerecke, C., Lindemann, W., Zeis, M., Weisel, K., Duerig, J., Jauch, A., Peters-Regehr, T., Zorn, M., Goldschmidt, H., Scheid, C., Hose, D., Bertsch, U., Hielscher, T., Kunz, C., Salwender, H., Haenel, M., Merz, M., Mai, E. K., Schurich, B., Munder, M., Schmidt-Wolf, I, Gerecke, C., Lindemann, W., Zeis, M., Weisel, K., Duerig, J., Jauch, A., Peters-Regehr, T., Zorn, M., and Goldschmidt, H.

Published
2015

18. Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial

Author

Merz, M., primary, Salwender, H., additional, Haenel, M., additional, Mai, E. K., additional, Bertsch, U., additional, Kunz, C., additional, Hielscher, T., additional, Blau, I. W., additional, Scheid, C., additional, Hose, D., additional, Seckinger, A., additional, Jauch, A., additional, Hillengass, J., additional, Raab, M. S., additional, Schurich, B., additional, Munder, M., additional, Schmidt-Wolf, I. G. H., additional, Gerecke, C., additional, Lindemann, H.-W., additional, Zeis, M., additional, Weisel, K., additional, Duerig, J., additional, and Goldschmidt, H., additional

Published
2015
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19. A magnetic resonance imaging-based prognostic scoring system to predict outcome in transplant-eligible patients with multiple myeloma

Author

Mai, E. K., primary, Hielscher, T., additional, Kloth, J. K., additional, Merz, M., additional, Shah, S., additional, Raab, M. S., additional, Hillengass, M., additional, Wagner, B., additional, Jauch, A., additional, Hose, D., additional, Weber, M.-A., additional, Delorme, S., additional, Goldschmidt, H., additional, and Hillengass, J., additional

Published
2015
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20. Bortezomib/cyclophosphamide/dexamethasone (VCD) is equally effective and has a favorable toxicity profile compared to bortezomib/doxorubicin/dexamethasone (PAd) as induction therapy in newly diagnosed, transplant-eligible myeloma patients: Results from the multicenter, phase III clinical trial GMMG-MM5

Author

Mai, E. K., Bertsch, U., Duerig, J., Kunz, C., Haenel, M., Blau, I. W., Munder, M., Jauch, A., Schurich, B., Hielscher, T., Merz, M., Huegle-Doerr, B., Seckinger, A., Hose, D., Hillengass, J., Raab, M. S., Neben, K., Lindemann, H-W, Zeis, M., Gerecke, C., Schmidt-Wolf, I. G. H., Weisel, K., Scheid, C., Salwender, H., Goldschmidt, H., Mai, E. K., Bertsch, U., Duerig, J., Kunz, C., Haenel, M., Blau, I. W., Munder, M., Jauch, A., Schurich, B., Hielscher, T., Merz, M., Huegle-Doerr, B., Seckinger, A., Hose, D., Hillengass, J., Raab, M. S., Neben, K., Lindemann, H-W, Zeis, M., Gerecke, C., Schmidt-Wolf, I. G. H., Weisel, K., Scheid, C., Salwender, H., and Goldschmidt, H.

Published
2014

21. Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial.

Author

Goldschmidt H, Lokhorst HM, Mai EK, van der Holt B, Blau IW, Zweegman S, Weisel KC, Vellenga E, Pfreundschuh M, Kersten MJ, Scheid C, Croockewit S, Raymakers R, Hose D, Potamianou A, Jauch A, Hillengass J, Stevens-Kroef M, Raab MS, Broijl A, Lindemann HW, Bos GMJ, Brossart P, van Marwijk Kooy M, Ypma P, Duehrsen U, Schaafsma RM, Bertsch U, Hielscher T, Jarari L, Salwender HJ, and Sonneveld P

Subjects
Adolescent, Adult, Aged, Chromosome Aberrations drug effects, Female, Follow-Up Studies, Hematopoietic Stem Cell Transplantation methods, Humans, Male, Melphalan therapeutic use, Middle Aged, Multiple Myeloma mortality, Multiple Myeloma pathology, Prognosis, Progression-Free Survival, Thalidomide therapeutic use, Transplantation, Autologous methods, Young Adult, Bortezomib administration & dosage, Multiple Myeloma drug therapy
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
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