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

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Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial. / Merz, Maximilian; Salwender, Hans; Haenel, Mathias; Mai, Elias K; Bertsch, Uta; Kunz, Christina; Hielscher, Thomas; Blau, Igor W; Scheid, Christof; Hose, Dirk; Seckinger, Anja; Jauch, Anna; Hillengass, Jens; Raab, Marc S; Schurich, Baerbel; Munder, Markus; Schmidt-Wolf, Ingo G H; Gerecke, Christian; Lindemann, Hans-Walter; Zeis, Matthias; Weisel, Katja; Duerig, Jan; Goldschmidt, Hartmut.

In: HAEMATOLOGICA, Vol. 100, No. 7, 07.2015, p. 964-9.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Merz, M, Salwender, H, Haenel, M, Mai, EK, Bertsch, U, Kunz, C, Hielscher, T, Blau, IW, Scheid, C, Hose, D, Seckinger, A, Jauch, A, Hillengass, J, Raab, MS, Schurich, B, Munder, M, Schmidt-Wolf, IGH, Gerecke, C, Lindemann, H-W, Zeis, M, Weisel, K, Duerig, J & Goldschmidt, H 2015, 'Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial', HAEMATOLOGICA, vol. 100, no. 7, pp. 964-9. https://doi.org/10.3324/haematol.2015.124347

APA

Merz, M., Salwender, H., Haenel, M., Mai, E. K., Bertsch, U., Kunz, C., Hielscher, T., Blau, I. W., Scheid, C., Hose, D., Seckinger, A., Jauch, A., Hillengass, J., Raab, M. S., Schurich, B., Munder, M., Schmidt-Wolf, I. G. H., Gerecke, C., Lindemann, H-W., ... Goldschmidt, H. (2015). Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial. HAEMATOLOGICA, 100(7), 964-9. https://doi.org/10.3324/haematol.2015.124347

Vancouver

Merz M, Salwender H, Haenel M, Mai EK, Bertsch U, Kunz C et al. Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial. HAEMATOLOGICA. 2015 Jul;100(7):964-9. https://doi.org/10.3324/haematol.2015.124347

Bibtex

@article{ad136c9bee434e0a8322068fb6893692,
title = "Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial",
abstract = "We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib, doxorubicin, and dexamethasone with bortezomib, cyclophosphamide, and dexamethasone induction therapy in newly diagnosed multiple myeloma. Based on data from relapsed myeloma, the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled. We analyzed 598 patients who received at least one dose of trial medication. Adverse events were reported more frequently in patients treated with intravenous bortezomib (intravenous=65%; subcutaneous=56%, P=0.02). Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle (intravenous=8%; subcutaneous=2%, P=0.001). Overall response rates were similar in patients treated intravenously or subcutaneously. The presence of International Staging System stage III disease, renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group. To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma. We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib. The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16. ",
keywords = "Adult, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Cyclophosphamide, Dexamethasone, Doxorubicin, Drug Administration Schedule, Female, Humans, Induction Chemotherapy, Injections, Intravenous, Injections, Subcutaneous, Kidney, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Peripheral Nervous System Diseases, Prospective Studies, Remission Induction, Survival Analysis, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "Maximilian Merz and Hans Salwender and Mathias Haenel and Mai, {Elias K} and Uta Bertsch and Christina Kunz and Thomas Hielscher and Blau, {Igor W} and Christof Scheid and Dirk Hose and Anja Seckinger and Anna Jauch and Jens Hillengass and Raab, {Marc S} and Baerbel Schurich and Markus Munder and Schmidt-Wolf, {Ingo G H} and Christian Gerecke and Hans-Walter Lindemann and Matthias Zeis and Katja Weisel and Jan Duerig and Hartmut Goldschmidt",
note = "Copyright{\textcopyright} Ferrata Storti Foundation.",
year = "2015",
month = jul,
doi = "10.3324/haematol.2015.124347",
language = "English",
volume = "100",
pages = "964--9",
journal = "HAEMATOLOGICA",
issn = "0390-6078",
publisher = "Ferrata Storti Foundation",
number = "7",

}

RIS

TY - JOUR

T1 - Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial

AU - Merz, Maximilian

AU - Salwender, Hans

AU - Haenel, Mathias

AU - Mai, Elias K

AU - Bertsch, Uta

AU - Kunz, Christina

AU - Hielscher, Thomas

AU - Blau, Igor W

AU - Scheid, Christof

AU - Hose, Dirk

AU - Seckinger, Anja

AU - Jauch, Anna

AU - Hillengass, Jens

AU - Raab, Marc S

AU - Schurich, Baerbel

AU - Munder, Markus

AU - Schmidt-Wolf, Ingo G H

AU - Gerecke, Christian

AU - Lindemann, Hans-Walter

AU - Zeis, Matthias

AU - Weisel, Katja

AU - Duerig, Jan

AU - Goldschmidt, Hartmut

N1 - Copyright© Ferrata Storti Foundation.

PY - 2015/7

Y1 - 2015/7

N2 - We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib, doxorubicin, and dexamethasone with bortezomib, cyclophosphamide, and dexamethasone induction therapy in newly diagnosed multiple myeloma. Based on data from relapsed myeloma, the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled. We analyzed 598 patients who received at least one dose of trial medication. Adverse events were reported more frequently in patients treated with intravenous bortezomib (intravenous=65%; subcutaneous=56%, P=0.02). Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle (intravenous=8%; subcutaneous=2%, P=0.001). Overall response rates were similar in patients treated intravenously or subcutaneously. The presence of International Staging System stage III disease, renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group. To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma. We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib. The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16.

AB - We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib, doxorubicin, and dexamethasone with bortezomib, cyclophosphamide, and dexamethasone induction therapy in newly diagnosed multiple myeloma. Based on data from relapsed myeloma, the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled. We analyzed 598 patients who received at least one dose of trial medication. Adverse events were reported more frequently in patients treated with intravenous bortezomib (intravenous=65%; subcutaneous=56%, P=0.02). Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle (intravenous=8%; subcutaneous=2%, P=0.001). Overall response rates were similar in patients treated intravenously or subcutaneously. The presence of International Staging System stage III disease, renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group. To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma. We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib. The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16.

KW - Adult

KW - Aged

KW - Antineoplastic Agents

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Bortezomib

KW - Cyclophosphamide

KW - Dexamethasone

KW - Doxorubicin

KW - Drug Administration Schedule

KW - Female

KW - Humans

KW - Induction Chemotherapy

KW - Injections, Intravenous

KW - Injections, Subcutaneous

KW - Kidney

KW - Male

KW - Middle Aged

KW - Multiple Myeloma

KW - Neoplasm Staging

KW - Peripheral Nervous System Diseases

KW - Prospective Studies

KW - Remission Induction

KW - Survival Analysis

KW - Clinical Trial, Phase III

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.3324/haematol.2015.124347

DO - 10.3324/haematol.2015.124347

M3 - SCORING: Journal article

C2 - 25840597

VL - 100

SP - 964

EP - 969

JO - HAEMATOLOGICA

JF - HAEMATOLOGICA

SN - 0390-6078

IS - 7

ER -