Journal Article

DKFZ-2020-00358

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.

Goldschmidt, H. ; Mai, E. K. ; Dürig, J. ; Scheid, C. ; Weisel, K. C. ; Kunz, C.DKFZ* ; Bertsch, U. ; Hielscher, T.DKFZ* ; Merz, M. ; Munder, M. ; Lindemann, H.-W. ; Hügle-Dörr, B. ; Tichy, D.DKFZ* ; Giesen, N. ; Hose, D. ; Seckinger, A. ; Huhn, S. ; Luntz, S. ; Jauch, A. ; Elmaagacli, A. ; Rabold, B. ; Fuhrmann, S. ; Brossart, P. ; Goerner, M. ; Bernhard, H. ; Hoffmann, M. ; Hillengass, J. ; Raab, M. S. ; Blau, I. W. ; Hänel, M. ; Salwender, H. J. ; Group, G. M. M. (Collaboration Author)

2020
Springer Nature London

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Please use a persistent id in citations: doi:10.1038/s41375-020-0724-1

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.

Note: 2020 Jul;34(7):1853-1865

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Contributing Institute(s):

1. C060 Biostatistik (C060)

Research Program(s):

1. 313 - Cancer risk factors and prevention (POF3-313) (POF3-313)

Appears in the scientific report 2020

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; BIOSIS Previews ; Clarivate Analytics Master Journal List ; Current Contents - Life Sciences ; Ebsco Academic Search ; IF >= 10 ; JCR ; NCBI Molecular Biology Database ; SCOPUS ; Science Citation Index ; Science Citation Index Expanded ; Web of Science Core Collection

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