% IMPORTANT: The following is UTF-8 encoded. This means that in the presence % of non-ASCII characters, it will not work with BibTeX 0.99 or older. % Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or % “biber”. @ARTICLE{Goldschmidt:157227, author = {H. Goldschmidt and M.-A. Baertsch and J. Schlenzka and N. Becker$^*$ and C. Habermehl$^*$ and T. Hielscher$^*$ and M.-S. Raab$^*$ and J. Hillengass and S. Sauer and C. Müller-Tidow and S. Luntz and A. Jauch and D. Hose and A. Seckinger and P. Brossart and M. Goerner and S. Klein and M. Schmidt-Hieber and P. Reimer and U. Graeven and R. Fenk and M. Haenel and H. Martin and H. W. Lindemann and C. Scheid and A. Nogai and H. Salwender and R. Noppeney and B. Besemer and K. Weisel}, collaboration = {G. M. M. Group}, title = {{S}alvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized {GMMG} phase {III} trial {R}e{LA}ps{E}.}, journal = {Leukemia}, volume = {35}, number = {4}, issn = {1476-5551}, address = {London}, publisher = {Springer Nature}, reportid = {DKFZ-2020-01497}, pages = {1134-1144}, year = {2021}, note = {2021 Apr;35(4):1134-1144}, 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.}, cin = {C060 / A360}, ddc = {610}, cid = {I:(DE-He78)C060-20160331 / I:(DE-He78)A360-20160331}, pnm = {311 - Zellbiologie und Tumorbiologie (POF4-311)}, pid = {G:(DE-HGF)POF4-311}, typ = {PUB:(DE-HGF)16}, pubmed = {pmid:32694619}, doi = {10.1038/s41375-020-0948-0}, url = {https://inrepo02.dkfz.de/record/157227}, }