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

J 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

MATEOS, M.V., T. MASSZI, N. GRZASKO, M. HANSSON, I. SANDHU et. al.

Basic information

Original name

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

Authors

Edition

haematologica, PAVIA, FERRATA STORTI FOUNDATION, 2017, 0390-6078

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30200 3.2 Clinical medicine

Country of publisher

Italy

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 9.090

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.3324/haematol.2017.170118

UT WoS

000411964200029

Keywords in English

ixazomib-lenalidomide-dexamethasone; placebo-lenalidomide-dexamethasone

Abstract

V originále

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 similar to 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 -naive patients, HR 0.744 and 0.700 in immunomodulatory-drug-exposed and -naive 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.

Citovat

MATEOS, M.V., T. MASSZI, N. GRZASKO, M. HANSSON, I. SANDHU, Luděk POUR, L. VITERBO, S.R. JACKSON, A.M. STOPPA, P. GIMSING, M. HAMADANI, G. BORSARU, D. BERG, J.C. LIN, A. DI BACCO, H. VAN DE VELDE, P.G. RICHARDSON and P. MOREAU. 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. PAVIA: FERRATA STORTI FOUNDATION, 2017, vol. 102, No 10, p. 1767-1775. ISSN 0390-6078. Available from: https://dx.doi.org/10.3324/haematol.2017.170118.

@article{1398976,
   author = {Mateos, M.V. and Masszi, T. and Grzasko, N. and Hansson, M. and Sandhu, I. and Pour, Luděk and Viterbo, L. and Jackson, S.R. and Stoppa, A.M. and Gimsing, P. and Hamadani, M. and Borsaru, G. and Berg, D. and Lin, J.C. and Di Bacco, A. and van de Velde, H. and Richardson, P.G. and Moreau, P.},
   article_location = {PAVIA},
   article_number = {10},
   doi = {http://dx.doi.org/10.3324/haematol.2017.170118},
   keywords = {ixazomib-lenalidomide-dexamethasone; placebo-lenalidomide-dexamethasone},
   language = {eng},
   issn = {0390-6078},
   journal = {haematologica},
   title = {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},
   url = {http://dx.doi.org/10.3324/haematol.2017.170118},
   volume = {102},
   year = {2017}
}

TY  - JOUR
ID  - 1398976
AU  - Mateos, M.V. - Masszi, T. - Grzasko, N. - Hansson, M. - Sandhu, I. - Pour, Luděk - Viterbo, L. - Jackson, S.R. - Stoppa, A.M. - Gimsing, P. - Hamadani, M. - Borsaru, G. - Berg, D. - Lin, J.C. - Di Bacco, A. - van de Velde, H. - Richardson, P.G. - Moreau, P.
PY  - 2017
TI  - 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
JF  - haematologica
VL  - 102
IS  - 10
SP  - 1767-1775
EP  - 1767-1775
PB  - FERRATA STORTI FOUNDATION
SN  - 03906078
KW  - ixazomib-lenalidomide-dexamethasone
KW  - placebo-lenalidomide-dexamethasone
UR  - http://dx.doi.org/10.3324/haematol.2017.170118
L2  - http://dx.doi.org/10.3324/haematol.2017.170118
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 similar to 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 -naive patients, HR 0.744 and 0.700 in immunomodulatory-drug-exposed and -naive 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.
ER  -

MATEOS, M.V., T. MASSZI, N. GRZASKO, M. HANSSON, I. SANDHU, Luděk POUR, L. VITERBO, S.R. JACKSON, A.M. STOPPA, P. GIMSING, M. HAMADANI, G. BORSARU, D. BERG, J.C. LIN, A. DI BACCO, H. VAN DE VELDE, P.G. RICHARDSON and P. MOREAU. 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. \textit{haematologica}. PAVIA: FERRATA STORTI FOUNDATION, 2017, vol.~102, No~10, p.~1767-1775. ISSN~0390-6078. Available from: https://dx.doi.org/10.3324/haematol.2017.170118.

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