Goldschmidt, Hartmut, Mai, Elias K., Duerig, Jan, Scheid, Christof, Weisel, Katja C., Kunz, Christina, Bertsch, Uta, Hielscher, Thomas, Merz, Maximilian, Munder, Markus, Lindemann, Hans-Walter, Huegle-Doerr, 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., Haenel, Mathias and Salwender, Hans J. (2020). Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial. Leukemia, 34 (7). S. 1853 - 1866. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Goldschmidt, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mai, Elias K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Duerig, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheid, ChristofUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weisel, Katja C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kunz, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bertsch, UtaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hielscher, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merz, MaximilianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Munder, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lindemann, Hans-WalterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huegle-Doerr, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tichy, DianaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giesen, NicolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hose, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seckinger, AnjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huhn, StefanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luntz, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jauch, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Elmaagacli, AhmetUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rabold, BernhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fuhrmann, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brossart, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goerner, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bernhard, HelgaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoffmann, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hillengass, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Raab, Marc S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blau, Igor W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haenel, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salwender, Hans J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-345310
DOI: 10.1038/s41375-020-0724-1
Journal or Publication Title: Leukemia
Volume: 34
Number: 7
Page Range: S. 1853 - 1866
Date: 2020
Publisher: NATURE PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1476-5551
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
STEM-CELL TRANSPLANTATION; MINIMAL RESIDUAL DISEASE; HIGH-RISK CYTOGENETICS; MULTIPLE-MYELOMA; CRITERIA; BORTEZOMIB; CONSENSUS; THERAPYMultiple languages
Oncology; HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/34531

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