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

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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. / Mateos, María-Victoria; Masszi, Tamas; Grzasko, Norbert; Hansson, Markus; Sandhu, Irwindeep; Pour, Ludek; Viterbo, Luísa; Jackson, Sharon R; Stoppa, Anne-Marie; Gimsing, Peter; Hamadani, Mehdi; Borsaru, Gabriela; Berg, Deborah; Lin, Jianchang; Di Bacco, Alessandra; van de Velde, Helgi; Richardson, Paul G; Moreau, Philippe.

I: Haematologica, Vol. 102, Nr. 10, 10.2017, s. 1767-1775.

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

Harvard

Mateos, M-V, Masszi, T, Grzasko, N, Hansson, M, Sandhu, I, Pour, L, Viterbo, L, Jackson, SR, Stoppa, A-M, Gimsing, P, Hamadani, M, Borsaru, G, Berg, D, Lin, J, Di Bacco, A, van de Velde, H, Richardson, PG & Moreau, P 2017, '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', Haematologica, vol. 102, nr. 10, s. 1767-1775. https://doi.org/10.3324/haematol.2017.170118

APA

CBE

Mateos M-V, Masszi T, Grzasko N, Hansson M, Sandhu I, Pour L, Viterbo L, Jackson SR, Stoppa A-M, Gimsing P, Hamadani M, Borsaru G, Berg D, Lin J, Di Bacco A, van de Velde H, Richardson PG, Moreau P. 2017. 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. Haematologica. 102(10):1767-1775. https://doi.org/10.3324/haematol.2017.170118

MLA

Vancouver

Author

Mateos, María-Victoria ; Masszi, Tamas ; Grzasko, Norbert ; Hansson, Markus ; Sandhu, Irwindeep ; Pour, Ludek ; Viterbo, Luísa ; Jackson, Sharon R ; Stoppa, Anne-Marie ; Gimsing, Peter ; Hamadani, Mehdi ; Borsaru, Gabriela ; Berg, Deborah ; Lin, Jianchang ; Di Bacco, Alessandra ; van de Velde, Helgi ; Richardson, Paul G ; Moreau, Philippe. / 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. I: Haematologica. 2017 ; Vol. 102, Nr. 10. s. 1767-1775.

RIS

TY - JOUR

T1 - 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

AU - Mateos, María-Victoria

AU - Masszi, Tamas

AU - Grzasko, Norbert

AU - Hansson, Markus

AU - Sandhu, Irwindeep

AU - Pour, Ludek

AU - Viterbo, Luísa

AU - Jackson, Sharon R

AU - Stoppa, Anne-Marie

AU - Gimsing, Peter

AU - Hamadani, Mehdi

AU - Borsaru, Gabriela

AU - Berg, Deborah

AU - Lin, Jianchang

AU - Di Bacco, Alessandra

AU - van de Velde, Helgi

AU - Richardson, Paul G

AU - Moreau, Philippe

N1 - Copyright© 2017 Ferrata Storti Foundation.

PY - 2017/10

Y1 - 2017/10

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.3324/haematol.2017.170118

DO - 10.3324/haematol.2017.170118

M3 - Article

VL - 102

SP - 1767

EP - 1775

JO - Haematologica-The Hematology Journal

T2 - Haematologica-The Hematology Journal

JF - Haematologica-The Hematology Journal

SN - 1592-8721

IS - 10

ER -