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Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial

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 receiv...

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Main Authors: Goldschmidt, Hartmut (Author) , Mai, Elias K. (Author) , Dürig, Jan (Author) , Scheid, Christoph (Author) , Weisel, Katja C. (Author) , Kunz, Christina (Author) , Bertsch, Uta (Author) , Hielscher, Thomas (Author) , Merz, Maximilian (Author) , Munder, Markus (Author) , Lindemann, Hans-Walter (Author) , Hügle-Dörr, Barbara (Author) , Tichy, Diana (Author) , Giesen, Nicola (Author) , Hose, Dirk (Author) , Seckinger, Anja (Author) , Huhn, Stefanie (Author) , Luntz, Steffen P. (Author) , Jauch, Anna (Author) , Elmaagacli, Ahmet (Author) , Rabold, Bernhard (Author) , Fuhrmann, Stephan (Author) , Brossart, Peter (Author) , Goerner, Martin (Author) , Bernhard, Helga (Author) , Hoffmann, Martin (Author) , Hillengaß, Jens (Author) , Raab, Marc-Steffen (Author) , Blau, Igor-Wolfgang (Author) , Hänel, Mathias (Author) , Salwender, Hans (Author)
Format: Article (Journal)
Language:English
Published: 7 February 2020
In: Leukemia
Year: 2020, Volume: 34, Issue: 7, Pages: 1853-1865
ISSN:1476-5551
DOI:10.1038/s41375-020-0724-1
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1038/s41375-020-0724-1
Verlag, lizenzpflichtig, Volltext: https://www.nature.com/articles/s41375-020-0724-1
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Author Notes:Hartmut Goldschmidt, Elias K. Mai, Jan Dürig, Christof Scheid, Katja C. Weisel, Christina Kunz, Uta Bertsch, Thomas Hielscher, Maximilian Merz, Markus Munder, Hans-Walter Lindemann, Barbara Hügle-Dörr, Diana Tichy, Nicola Giesen, Dirk Hose, Anja Seckinger, Stefanie Huhn, Steffen Luntz, Anna Jauch, Ahmet Elmaagacli, Bernhard Rabold, Stephan Fuhrmann, Peter Brossart, Martin Goerner, Helga Bernhard, Martin Hoffmann, Jens Hillengass, Marc S. Raab, Igor W. Blau, Mathias Hänel, Hans J. Salwender for the German-speaking Myeloma Multicenter Group (GMMG)
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Summary: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.
Item Description:Gesehen am 09.09.2021
Physical Description:Online Resource
ISSN:1476-5551
DOI:10.1038/s41375-020-0724-1

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