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Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE

Standard

Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE. / Goldschmidt, Hartmut; Baertsch, Marc-Andrea; Schlenzka, Jana; Becker, Natalia; Habermehl, Christina; Hielscher, Thomas; Raab, Marc-Steffen; Hillengass, Jens; Sauer, Sandra; Müller-Tidow, Carsten; Luntz, Steffen; Jauch, Anna; Hose, Dirk; Seckinger, Anja; Brossart, Peter; Goerner, Martin; Klein, Stefan; Schmidt-Hieber, Martin; Reimer, Peter; Graeven, Ullrich; Fenk, Roland; Haenel, Mathias; Martin, Hans; Lindemann, Hans W; Scheid, Christoph; Nogai, Axel; Salwender, Hans; Noppeney, Richard; Besemer, Britta; Weisel, Katja; German Myeloma Multicenter Group (GMMG).

in: LEUKEMIA, Jahrgang 35, Nr. 4, 04.2021, S. 1134-1144.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Goldschmidt, H, Baertsch, M-A, Schlenzka, J, Becker, N, Habermehl, C, Hielscher, T, Raab, M-S, Hillengass, J, Sauer, S, Müller-Tidow, C, Luntz, S, Jauch, A, Hose, D, Seckinger, A, Brossart, P, Goerner, M, Klein, S, Schmidt-Hieber, M, Reimer, P, Graeven, U, Fenk, R, Haenel, M, Martin, H, Lindemann, HW, Scheid, C, Nogai, A, Salwender, H, Noppeney, R, Besemer, B, Weisel, K & German Myeloma Multicenter Group (GMMG) 2021, 'Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE', LEUKEMIA, Jg. 35, Nr. 4, S. 1134-1144. https://doi.org/10.1038/s41375-020-0948-0

APA

Goldschmidt, H., Baertsch, M-A., Schlenzka, J., Becker, N., Habermehl, C., Hielscher, T., Raab, M-S., Hillengass, J., Sauer, S., Müller-Tidow, C., Luntz, S., Jauch, A., Hose, D., Seckinger, A., Brossart, P., Goerner, M., Klein, S., Schmidt-Hieber, M., Reimer, P., ... German Myeloma Multicenter Group (GMMG) (2021). Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE. LEUKEMIA, 35(4), 1134-1144. https://doi.org/10.1038/s41375-020-0948-0

Vancouver

Goldschmidt H, Baertsch M-A, Schlenzka J, Becker N, Habermehl C, Hielscher T et al. Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE. LEUKEMIA. 2021 Apr;35(4):1134-1144. https://doi.org/10.1038/s41375-020-0948-0

Bibtex

@article{893a2a06a3cd47d5a1026edf153d976f,
title = "Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE",
abstract = "The role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n = 139) consisting of 3 Rd (lenalidomide 25 mg, day 1-21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m2), ASCT, and lenalidomide maintenance (10 mg/day) or to a control arm (n = 138) of continuous Rd. Median PFS was 20.7 months in the transplant and 18.8 months in the control arm (HR 0.87; 95% CI 0.65-1.16; p = 0.34). Median OS was not reached in the transplant and 62.7 months in the control arm (HR 0.81; 95% CI 0.52-1.28; p = 0.37). Forty-one patients (29%) did not receive the assigned sHDCT/ASCT mainly due to early disease progression, adverse events, and withdrawal of consent. Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p = 0.0087/0.0057) in patients who received sHDCT/ASCT. Incorporation of sHDCT/ASCT into relapse treatment with Rd was feasible in 71% of patients and did not significantly prolong PFS and OS on ITT analysis while patients who received sHDCT/ASCT may have benefitted.",
author = "Hartmut Goldschmidt and Marc-Andrea Baertsch and Jana Schlenzka and Natalia Becker and Christina Habermehl and Thomas Hielscher and Marc-Steffen Raab and Jens Hillengass and Sandra Sauer and Carsten M{\"u}ller-Tidow and Steffen Luntz and Anna Jauch and Dirk Hose and Anja Seckinger and Peter Brossart and Martin Goerner and Stefan Klein and Martin Schmidt-Hieber and Peter Reimer and Ullrich Graeven and Roland Fenk and Mathias Haenel and Hans Martin and Lindemann, {Hans W} and Christoph Scheid and Axel Nogai and Hans Salwender and Richard Noppeney and Britta Besemer and Katja Weisel and {German Myeloma Multicenter Group (GMMG)}",
year = "2021",
month = apr,
doi = "10.1038/s41375-020-0948-0",
language = "English",
volume = "35",
pages = "1134--1144",
journal = "LEUKEMIA",
issn = "0887-6924",
publisher = "NATURE PUBLISHING GROUP",
number = "4",

}

RIS

TY - JOUR

T1 - Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE

AU - Goldschmidt, Hartmut

AU - Baertsch, Marc-Andrea

AU - Schlenzka, Jana

AU - Becker, Natalia

AU - Habermehl, Christina

AU - Hielscher, Thomas

AU - Raab, Marc-Steffen

AU - Hillengass, Jens

AU - Sauer, Sandra

AU - Müller-Tidow, Carsten

AU - Luntz, Steffen

AU - Jauch, Anna

AU - Hose, Dirk

AU - Seckinger, Anja

AU - Brossart, Peter

AU - Goerner, Martin

AU - Klein, Stefan

AU - Schmidt-Hieber, Martin

AU - Reimer, Peter

AU - Graeven, Ullrich

AU - Fenk, Roland

AU - Haenel, Mathias

AU - Martin, Hans

AU - Lindemann, Hans W

AU - Scheid, Christoph

AU - Nogai, Axel

AU - Salwender, Hans

AU - Noppeney, Richard

AU - Besemer, Britta

AU - Weisel, Katja

AU - German Myeloma Multicenter Group (GMMG)

PY - 2021/4

Y1 - 2021/4

N2 - The role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n = 139) consisting of 3 Rd (lenalidomide 25 mg, day 1-21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m2), ASCT, and lenalidomide maintenance (10 mg/day) or to a control arm (n = 138) of continuous Rd. Median PFS was 20.7 months in the transplant and 18.8 months in the control arm (HR 0.87; 95% CI 0.65-1.16; p = 0.34). Median OS was not reached in the transplant and 62.7 months in the control arm (HR 0.81; 95% CI 0.52-1.28; p = 0.37). Forty-one patients (29%) did not receive the assigned sHDCT/ASCT mainly due to early disease progression, adverse events, and withdrawal of consent. Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p = 0.0087/0.0057) in patients who received sHDCT/ASCT. Incorporation of sHDCT/ASCT into relapse treatment with Rd was feasible in 71% of patients and did not significantly prolong PFS and OS on ITT analysis while patients who received sHDCT/ASCT may have benefitted.

AB - The role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n = 139) consisting of 3 Rd (lenalidomide 25 mg, day 1-21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m2), ASCT, and lenalidomide maintenance (10 mg/day) or to a control arm (n = 138) of continuous Rd. Median PFS was 20.7 months in the transplant and 18.8 months in the control arm (HR 0.87; 95% CI 0.65-1.16; p = 0.34). Median OS was not reached in the transplant and 62.7 months in the control arm (HR 0.81; 95% CI 0.52-1.28; p = 0.37). Forty-one patients (29%) did not receive the assigned sHDCT/ASCT mainly due to early disease progression, adverse events, and withdrawal of consent. Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p = 0.0087/0.0057) in patients who received sHDCT/ASCT. Incorporation of sHDCT/ASCT into relapse treatment with Rd was feasible in 71% of patients and did not significantly prolong PFS and OS on ITT analysis while patients who received sHDCT/ASCT may have benefitted.

U2 - 10.1038/s41375-020-0948-0

DO - 10.1038/s41375-020-0948-0

M3 - SCORING: Journal article

C2 - 32694619

VL - 35

SP - 1134

EP - 1144

JO - LEUKEMIA

JF - LEUKEMIA

SN - 0887-6924

IS - 4

ER -