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Clinical Trial
. 2021 Jan 7;11(1):1.
doi: 10.1038/s41408-020-00390-3.

Lenalidomide versus bortezomib maintenance after frontline autologous stem cell transplantation for multiple myeloma

Marc-Andrea Baertsch  1 , Elias K Mai  1 , Thomas Hielscher  2 , Uta Bertsch  1   3 , Hans J Salwender  4 , Markus Munder  5 , Stephan Fuhrmann  6 , Ulrich Dührsen  7 , Peter Brossart  8 , Kai Neben  9 , Jana Schlenzka  1   3 , Christina Kunz  2   10 , Marc S Raab  1 , Jens Hillengaß  1   11 , Anna Jauch  12 , Anja Seckinger  1 , Dirk Hose  1   13 , Steffen Luntz  14 , Pieter Sonneveld  15 , Henk Lokhorst  16 , Hans Martin  17 , Martin Goerner  18 , Martin Hoffmann  19 , Hans-Walter Lindemann  20 , Helga Bernhard  21 , Igor W Blau  22 , Christof Scheid  23 , Britta Besemer  24 , Katja C Weisel  25 , Mathias Hänel  26 , Jan Dürig  7 , Hartmut Goldschmidt  27   28 ; German-Speaking Myeloma Multicenter Group (GMMG)
Affiliations
Clinical Trial

Lenalidomide versus bortezomib maintenance after frontline autologous stem cell transplantation for multiple myeloma

Marc-Andrea Baertsch et al. Blood Cancer J. .

Abstract

Lenalidomide (LEN) maintenance (MT) post autologous stem cell transplantation (ASCT) is standard of care in newly diagnosed multiple myeloma (MM) but has not been compared to other agents in clinical trials. We retrospectively compared bortezomib (BTZ; n = 138) or LEN (n = 183) MT from two subsequent GMMG phase III trials. All patients received three cycles of BTZ-based triplet induction and post-ASCT MT. BTZ MT (1.3 mg/m2 i.v.) was administered every 2 weeks for 2 years. LEN MT included two consolidation cycles (25 mg p.o., days 1-21 of 28 day cycles) followed by 10-15 mg/day for 2 years. The BTZ cohort more frequently received tandem ASCT (91% vs. 33%) due to different tandem ASCT strategies. In the LEN and BTZ cohort, 43% and 46% of patients completed 2 years of MT as intended (p = 0.57). Progression-free survival (PFS; HR = 0.83, p = 0.18) and overall survival (OS; HR = 0.70, p = 0.15) did not differ significantly with LEN vs. BTZ MT. Patients with <nCR after first ASCT were assigned tandem ASCT in both trials. In patients with <nCR and tandem ASCT (LEN: n = 54 vs. BTZ: n = 84), LEN MT significantly improved PFS (HR = 0.61, p = 0.04) but not OS (HR = 0.46, p = 0.09). In conclusion, the significant PFS benefit after eliminating the impact of different tandem ASCT rates supports the current standard of LEN MT after ASCT.

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Conflict of interest statement

MAB: Takeda: Consultancy, honoraria; Novartis: Consultancy, Research Funding; Celgene, Amgen, Janssen: Travel grants. EKM: honoraria: Janssen, Celgene, Takeda; consulting or advisory role: Janssen, Celgene, Takeda; research funding: Takeda; travel, accommodations, expenses: Janssen, Takeda, Celgene, Mundipharma. TH: no COI. UB: no COI. HJS: Amgen: Honoraria, Other: Travel or accommodations; Bristol-Myers Squibb: Honoraria, Other: Travel or accommodations; Janssen Cilag: Honoraria, Other: Travel or accommodations; Sanofi: Honoraria, Other: Travel or accommodations; Celgene: Honoraria, Other: Travel or accommodations; AbbVie: Honoraria; Takeda: Honoraria, Other: Travel or accommodations. MMu: honoraria: Janssen, BMS, Takeda, Celgene, Amgen; consulting or advisory role: Janssen, BMS, Takeda, Celgene, Amgen; research funding: BMS; travel, accomodations, expenses: Janssen, BMS, Takeda, Amgen. SF: Advisory board: BMS, Celgene und Amgen. UD: Alexion: Honoraria; Janssen: Honoraria. PB: consulting or advisory role: BMS, AMGEN, Roche, MSD; research funding: BMS; travel, accomodations, expenses: BMS. KN: no COI. JS: no COI. CK: no COI. MSR: honoraria: Celgene, BMS,Novartis, Janssen, Takeda; consulting or advisory role: Celgene, BMS,Novartis, Janssen, Takeda; research funding: Celgene, Novartis, AMGEN; travel, accomodations, expenses: Janssen, BMS, Takeda. JH: Advisory boards: Adaptive, Amgen, BMS, Celgene, GSK, Janssen, Oncotracker. AJ: no COI. AS: no COI. DH: no COI. SL: no COI. PS: SkylineDx: Membership on an entity’s Board of Directors or advisory committees; Karyopharm: Research Funding; Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding. HL: Janssen: Honoraria, Research Funding; Genmab: Honoraria, Research Funding; Amgen: Honoraria. HM: no COI. MG: no COI. MHo: honoraria: MSD. HWL: no COI. HB: no COI. IWB: research funding: Celgene, BMS, Janssen. CS: honoraria: BMS, Janssen, Celgene, Novartis, Amgen, Takeda; consulting or advisory role: BMS, Janssen, Celgene, Novartis, Amgen, Takeda; speakers bureau: Takeda; research funding: Takeda, Novartis; travel, accomodations, expenses: BMS, Janssen, Celgene, Novartis, Amgen, Takeda. BB: no COI. KCW: honoraria: AMGEN, BMS, Celgene, Novartis, Janssen, Takeda; consulting or advisory role: AMGEN, BMS, Celgene, Juno, Janssen, Adaptive, Sanofi, Takeda; research funding: AMGEN, Celgene, Sanofi, Janssen. MHä: honoraria: Novartis, Amgen, Roche, Takeda; consulting or advisory role: Celgene. JD: consulting or advisory role: Celgene; speakers bureau: Celgene; travel, accomodations, expenses: Celgene. HG: honoraria: Amgen, BMS, Celgene, Chugai, Janssen, Novartis, Takeda; consulting or advisory role: Amgen, BMS, Celgene, Chugai, Janssen, Novartis, Takeda; speakers bureau: Amgen, BMS, Celgene, Janssen, Novartis, Takeda; research funding: Amgen, BMS, Celgene, Chugai, Janssen, Novartis, Takeda; travel, accomodations, expenses: BMS, Celgene, Janssen, Novartis, Takeda.

Figures

Fig. 1
Fig. 1. Progression-free (PFS) and overall survival (OS) in the overall cohorts.
Kaplan–Meier curves are shown for (a) PFS and (b) OS. LEN lenalidomide, BTZ bortezomib.
Fig. 2
Fig. 2. Subgroup analyses on progression-free survival (PFS) according to baseline factors.
Multivariate subgroup analyses adjusted for response (CR/nCR vs.2 mg/dl [yes] vs. <2 mg/dl [no]); Hyperdiploidy cytogenetic hyperdiploidy [HD].
Fig. 3
Fig. 3. Subgroup analyses on overall survival (OS) according to baseline factors.
Multivariate subgroup analyses adjusted for response (CR/nCR vs.2 mg/dl [yes] vs. <2 mg/dl [no]); Hyperdiploidy: cytogenetic hyperdiploidy [HD].
Fig. 4
Fig. 4. Progression-free (PFS) and overall survival (OS) in patients receiving tandem autologous stem cell transplants (ASCT) for
Kaplan–Meier curves are shown for (a) PFS and (b) OS. LEN lenalidomide, BTZ bortezomib.
See this image and copyright information in PMC

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