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  • Mateos, María-VictoriaUniversity Hospital of Salamanca (author)

Impact of prior therapy on the efficacy and safety of oral ixazomib-lenalidomide-dexamethasone vs. placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1

  • Article/chapterEnglish2017

Publisher, publication year, extent ...

  • 2017-07-27
  • Ferrata Storti Foundation (Haematologica),2017
  • 9 s.

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  • LIBRIS-ID:oai:lup.lub.lu.se:5d8bf9fc-671d-4250-a550-09d655f2be1d
  • https://lup.lub.lu.se/record/5d8bf9fc-671d-4250-a550-09d655f2be1dURI
  • https://doi.org/10.3324/haematol.2017.170118DOI

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  • Language:English
  • Summary in:English

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  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • Prior treatment exposure in patients with relapsed/refractory multiple myeloma may affect outcomes with subsequent therapies. We analyzed efficacy and safety according to prior treatment in the phase 3 TOURMALINE-MM1 study of ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) versus placebo-Rd. Patients with relapsed/refractory multiple myeloma received ixazomib-Rd or placebo-Rd. Efficacy and safety were evaluated in subgroups defined according to type (proteasome inhibitor [PI] and immunomodulatory drug) and number (1 vs. 2 or 3) of prior therapies received. Of 722 patients, 503 (70%) had received a prior PI, and 397 (55%) prior lenalidomide/thalidomide; 425 patients had received 1 prior therapy, and 297 received 2 or 3 prior therapies. At a median follow up of ~15 months, PFS was prolonged with ixazomib-Rd vs. placebo-Rd regardless of type of prior therapy received; HR 0.739 and 0.749 in PI-exposed and -naïve patients, HR 0.744 and 0.700 in immunomodulatory-drug-exposed and -naïve patients, respectively. PFS benefit with ixazomib-Rd vs. placebo-Rd appeared greater in patients with 2 or 3 prior therapies (HR 0.58) and in those with 1 prior therapy without prior transplant (HR 0.60) versus those with 1 prior therapy and transplant (HR 1.23). Across all subgroups, toxicity was consistent with that seen in the intent-to-treat population. In patients with relapsed/refractory multiple myeloma, ixazomib-Rd was associated with a consistent clinical benefit vs. placebo-Rd regardless of prior treatment with bortezomib or immunomodulatory drugs. Patients with 2 or 3 prior therapies, or 1 prior therapy without transplant seemed to have greater benefit than patients with 1 prior therapy and transplant. TOURMALINE-MM1 registered at clinicaltrials.gov identifier: 01564537.

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Added entries (persons, corporate bodies, meetings, titles ...)

  • Masszi, TamasSemmelweis University (author)
  • Grzasko, NorbertMedical University of Lublin (author)
  • Hansson, MarkusLund University,Lunds universitet,Avdelningen för hematologi och transfusionsmedicin,Institutionen för laboratoriemedicin,Medicinska fakulteten,Division of Hematology and Transfusion Medicine,Department of Laboratory Medicine,Faculty of Medicine,Skåne University Hospital(Swepub:lu)hema-mha (author)
  • Sandhu, IrwindeepUniversity of Alberta (author)
  • Pour, LudekMasaryk University (author)
  • Viterbo, LuísaInstituto Português de Oncologia do Porto Francisco Gentil (IPO) (author)
  • Jackson, Sharon RMiddlemore Hospital, Auckland (author)
  • Stoppa, Anne-MarieInstitut Paoli-Calmettes (author)
  • Gimsing, PeterCopenhagen University Hospital (author)
  • Hamadani, MehdiMedical College of Wisconsin (author)
  • Borsaru, GabrielaColțea Hospital (author)
  • Berg, DeborahTakeda Oncology Inc. (author)
  • Lin, JianchangTakeda Oncology Inc. (author)
  • Di Bacco, AlessandraTakeda Oncology Inc. (author)
  • van de Velde, HelgiTakeda Oncology Inc. (author)
  • Richardson, Paul GDana-Farber Cancer Institute (author)
  • Moreau, PhilippeNantes University Hospital (author)
  • University Hospital of SalamancaSemmelweis University (creator_code:org_t)

Related titles

  • In:Haematologica: Ferrata Storti Foundation (Haematologica)102:10, s. 1767-17751592-87210390-6078

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