Response-adapted lenalidomide maintenance in newly diagnosed myeloma
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Response-adapted lenalidomide maintenance in newly diagnosed myeloma : results from the phase III GMMG-MM5 trial. / Goldschmidt, Hartmut; Mai, Elias K; Dürig, Jan; Scheid, Christof; Weisel, Katja C; Kunz, Christina; Bertsch, Uta; Hielscher, Thomas; Merz, Maximilian; Munder, Markus; Lindemann, Hans-Walter; Hügle-Dörr, Barbara; Tichy, Diana; Giesen, Nicola; Hose, Dirk; Seckinger, Anja; Huhn, Stefanie; Luntz, Steffen; Jauch, Anna; Elmaagacli, Ahmet; Rabold, Bernhard; Fuhrmann, Stephan; Brossart, Peter; Goerner, Martin; Bernhard, Helga; Hoffmann, Martin; Hillengass, Jens; Raab, Marc S; Blau, Igor W; Hänel, Mathias; Salwender, Hans J; German-speaking Myeloma Multicenter Group (GMMG).
In: LEUKEMIA, Vol. 34, No. 7, 07.2020, p. 1853-1865.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Response-adapted lenalidomide maintenance in newly diagnosed myeloma
T2 - results from the phase III GMMG-MM5 trial
AU - Goldschmidt, Hartmut
AU - Mai, Elias K
AU - Dürig, Jan
AU - Scheid, Christof
AU - Weisel, Katja C
AU - Kunz, Christina
AU - Bertsch, Uta
AU - Hielscher, Thomas
AU - Merz, Maximilian
AU - Munder, Markus
AU - Lindemann, Hans-Walter
AU - Hügle-Dörr, Barbara
AU - Tichy, Diana
AU - Giesen, Nicola
AU - Hose, Dirk
AU - Seckinger, Anja
AU - Huhn, Stefanie
AU - Luntz, Steffen
AU - Jauch, Anna
AU - Elmaagacli, Ahmet
AU - Rabold, Bernhard
AU - Fuhrmann, Stephan
AU - Brossart, Peter
AU - Goerner, Martin
AU - Bernhard, Helga
AU - Hoffmann, Martin
AU - Hillengass, Jens
AU - Raab, Marc S
AU - Blau, Igor W
AU - Hänel, Mathias
AU - Salwender, Hans J
AU - German-speaking Myeloma Multicenter Group (GMMG)
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
U2 - 10.1038/s41375-020-0724-1
DO - 10.1038/s41375-020-0724-1
M3 - SCORING: Journal article
C2 - 32034285
VL - 34
SP - 1853
EP - 1865
JO - LEUKEMIA
JF - LEUKEMIA
SN - 0887-6924
IS - 7
ER -