Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE
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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, Vol. 35, No. 4, 04.2021, p. 1134-1144.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -