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@ARTICLE{Goldschmidt:153635,
author = {H. Goldschmidt and E. K. Mai and J. Dürig and C. Scheid
and K. C. Weisel and C. Kunz$^*$ and U. Bertsch and T.
Hielscher$^*$ and M. Merz and M. Munder and H.-W. Lindemann
and B. Hügle-Dörr and D. Tichy$^*$ and N. Giesen and D.
Hose and A. Seckinger and S. Huhn and S. Luntz and A. Jauch
and A. Elmaagacli and B. Rabold and S. Fuhrmann and P.
Brossart and M. Goerner and H. Bernhard and M. Hoffmann and
J. Hillengass and M. S. Raab and I. W. Blau and M. Hänel
and H. J. Salwender},
collaboration = {G. M. M. Group},
title = {{R}esponse-adapted lenalidomide maintenance in newly
diagnosed myeloma: results from the phase {III} {GMMG}-{MM}5
trial.},
journal = {Leukemia},
volume = {34},
number = {7},
issn = {1476-5551},
address = {London},
publisher = {Springer Nature},
reportid = {DKFZ-2020-00358},
pages = {1853-1865},
year = {2020},
note = {2020 Jul;34(7):1853-1865},
abstract = {The MM5 trial aimed at demonstrating a progression-free
survival (PFS) difference in continued vs. response-adapted
(in case of complete response, CR) lenalidomide (LEN)
maintenance therapy (MT) in newly diagnosed,
transplant-eligible multiple myeloma (MM). Patients were
equally randomized to receive induction therapy with PAd
(bortezomib/doxorubicin/dexamethasone) or VCD
(bortezomib/cyclophosphamide/dexamethasone), high-dose
melphalan and autologous blood stem cell transplantation,
and LEN consolidation, followed by either LEN MT for a fixed
duration of 2 years (LEN-2Y) or until achievement of CR
(LEN-CR, intention-to-treat population n = 502): arms
A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR
(n = 126), A2:VCD + LEN-2Y (n = 126),
B2:VCD + LEN-CR (n = 125). In the LEN-CR group
(B1 + B2), $n = 88/17.5\%$ patients did not start or
discontinued LEN MT due to CR. There was no PFS
(p = 0.60, primary endpoint) nor overall survival (OS)
(p = 0.15) difference between the four study arms. On
pooled LEN MT strategies, OS (hazard ratio, hazard ratio
[HR] = 1.42, p = 0.03) but not PFS (HR = 1.15,
p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y
(A1 + A2) groups. PFS was shortened on landmark analyses
from the start of LEN MT in patients being in CR in the
LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84,
p = 0.02). OS from first progression was shortened in
the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01).
LEN MT should be applied beyond CR for at least 2 years.},
cin = {C060},
ddc = {610},
cid = {I:(DE-He78)C060-20160331},
pnm = {313 - Cancer risk factors and prevention (POF3-313)},
pid = {G:(DE-HGF)POF3-313},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:32034285},
doi = {10.1038/s41375-020-0724-1},
url = {https://inrepo02.dkfz.de/record/153635},
}