Home > Publications database > Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial. > print

001     153635
005     20240229123046.0
024 7 _ |a 10.1038/s41375-020-0724-1
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024 7 _ |a pmid:32034285
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024 7 _ |a 0887-6924
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024 7 _ |a 1476-5551
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037 _ _ |a DKFZ-2020-00358
041 _ _ |a eng
082 _ _ |a 610
100 1 _ |a Goldschmidt, Hartmut
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245 _ _ |a Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.
260 _ _ |a London
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|b Springer Nature
336 7 _ |a article
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336 7 _ |a Journal Article
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500 _ _ |a 2020 Jul;34(7):1853-1865
520 _ _ |a 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.
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700 1 _ |a Mai, Elias K
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700 1 _ |a Dürig, Jan
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700 1 _ |a Scheid, Christof
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700 1 _ |a Weisel, Katja C
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700 1 _ |a Kunz, Christina
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700 1 _ |a Bertsch, Uta
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700 1 _ |a Hielscher, Thomas
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700 1 _ |a Merz, Maximilian
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700 1 _ |a Munder, Markus
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700 1 _ |a Lindemann, Hans-Walter
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700 1 _ |a Hügle-Dörr, Barbara
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700 1 _ |a Tichy, Diana
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700 1 _ |a Giesen, Nicola
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700 1 _ |a Hose, Dirk
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700 1 _ |a Seckinger, Anja
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700 1 _ |a Huhn, Stefanie
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700 1 _ |a Luntz, Steffen
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700 1 _ |a Jauch, Anna
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700 1 _ |a Elmaagacli, Ahmet
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700 1 _ |a Rabold, Bernhard
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700 1 _ |a Fuhrmann, Stephan
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700 1 _ |a Brossart, Peter
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700 1 _ |a Goerner, Martin
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700 1 _ |a Bernhard, Helga
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700 1 _ |a Hoffmann, Martin
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700 1 _ |a Hillengass, Jens
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700 1 _ |a Raab, Marc S
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700 1 _ |a Blau, Igor W
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700 1 _ |a Hänel, Mathias
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700 1 _ |a Salwender, Hans J
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700 1 _ |a Group, German-speaking Myeloma Multicenter
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773 _ _ |a 10.1038/s41375-020-0724-1
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