Patient-reported health-related quality of life from the phase III TOURMALINE-MM1 study of ixazomib-lenalidomide-dexamethasone versus placebo-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma

Xavier Leleu, T. Masszi, Nizar J. Bahlis, Luisa Viterbo, Bartrum Baker, Peter Gimsing, Vladimir Maisnar, Olga Samoilova, Laura Rosiñol, Christian Langer, Kevin Song, Tohru Izumi, Charles Cleeland, Deborah Berg, Huamao Mark Lin, Yanyan Zhu, Tomas Skacel, Philippe Moreau, Paul G. Richardson

Research output: Article

14 Citations (Scopus)

Abstract

TOURMALINE-MM1 is a phase III, randomized, double-blind, placebo-controlled study of ixazomib plus lenalidomide and dexamethasone (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma following 1–3 prior lines of therapy. The study met its primary endpoint, demonstrating significantly longer progression-free survival (PFS) in the IRd arm versus placebo-Rd arm (median 20.6 vs 14.7 months, hazard ratio 0.74, P =.01), with limited additional toxicity. Patient-reported health-related quality of life (HRQoL) was a secondary endpoint of TOURMALINE-MM1. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) and Multiple Myeloma Module 20 (QLQ-MY20) were completed at screening, the start of cycles 1 and 2, every other cycle, the end of treatment, and every 4 weeks until progression. Over median follow-up of 23.3 and 22.9 months in the IRd and placebo-Rd arms, mean QLQ-C30 global health status (GHS)/QoL scores were maintained from baseline over the course of treatment in both groups, with no statistically significant differences between groups. EORTC QLQ-C30 function domain scores were also generally maintained from baseline; similarly, physical, emotional, and social function domains were maintained with IRd versus placebo-Rd, with slightly higher mean change from baseline scores at earlier time points with IRd. Findings from this double-blind study demonstrate that addition of ixazomib to Rd significantly improved efficacy while HRQoL was maintained, reflecting the limited additional toxicity seen with IRd versus placebo-Rd, and support the feasibility of long-term IRd administration.

Original languageEnglish
Pages (from-to)985-993
Number of pages9
JournalAmerican Journal of Hematology
Volume93
Issue number8
DOIs
Publication statusPublished - aug. 1 2018

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Multiple Myeloma
Dexamethasone
Placebos
Quality of Life
Therapeutics
Double-Blind Method
Health Status
Disease-Free Survival
ixazomib
lenalidomide
Organizations
Research
Surveys and Questionnaires
Neoplasms

ASJC Scopus subject areas

  • Hematology

Cite this

Patient-reported health-related quality of life from the phase III TOURMALINE-MM1 study of ixazomib-lenalidomide-dexamethasone versus placebo-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma. / Leleu, Xavier; Masszi, T.; Bahlis, Nizar J.; Viterbo, Luisa; Baker, Bartrum; Gimsing, Peter; Maisnar, Vladimir; Samoilova, Olga; Rosiñol, Laura; Langer, Christian; Song, Kevin; Izumi, Tohru; Cleeland, Charles; Berg, Deborah; Lin, Huamao Mark; Zhu, Yanyan; Skacel, Tomas; Moreau, Philippe; Richardson, Paul G.

In: American Journal of Hematology, Vol. 93, No. 8, 01.08.2018, p. 985-993.

Research output: Article

Leleu, X, Masszi, T, Bahlis, NJ, Viterbo, L, Baker, B, Gimsing, P, Maisnar, V, Samoilova, O, Rosiñol, L, Langer, C, Song, K, Izumi, T, Cleeland, C, Berg, D, Lin, HM, Zhu, Y, Skacel, T, Moreau, P & Richardson, PG 2018, 'Patient-reported health-related quality of life from the phase III TOURMALINE-MM1 study of ixazomib-lenalidomide-dexamethasone versus placebo-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma', American Journal of Hematology, vol. 93, no. 8, pp. 985-993. https://doi.org/10.1002/ajh.25134
Leleu, Xavier ; Masszi, T. ; Bahlis, Nizar J. ; Viterbo, Luisa ; Baker, Bartrum ; Gimsing, Peter ; Maisnar, Vladimir ; Samoilova, Olga ; Rosiñol, Laura ; Langer, Christian ; Song, Kevin ; Izumi, Tohru ; Cleeland, Charles ; Berg, Deborah ; Lin, Huamao Mark ; Zhu, Yanyan ; Skacel, Tomas ; Moreau, Philippe ; Richardson, Paul G. / Patient-reported health-related quality of life from the phase III TOURMALINE-MM1 study of ixazomib-lenalidomide-dexamethasone versus placebo-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma. In: American Journal of Hematology. 2018 ; Vol. 93, No. 8. pp. 985-993.
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abstract = "TOURMALINE-MM1 is a phase III, randomized, double-blind, placebo-controlled study of ixazomib plus lenalidomide and dexamethasone (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma following 1–3 prior lines of therapy. The study met its primary endpoint, demonstrating significantly longer progression-free survival (PFS) in the IRd arm versus placebo-Rd arm (median 20.6 vs 14.7 months, hazard ratio 0.74, P =.01), with limited additional toxicity. Patient-reported health-related quality of life (HRQoL) was a secondary endpoint of TOURMALINE-MM1. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) and Multiple Myeloma Module 20 (QLQ-MY20) were completed at screening, the start of cycles 1 and 2, every other cycle, the end of treatment, and every 4 weeks until progression. Over median follow-up of 23.3 and 22.9 months in the IRd and placebo-Rd arms, mean QLQ-C30 global health status (GHS)/QoL scores were maintained from baseline over the course of treatment in both groups, with no statistically significant differences between groups. EORTC QLQ-C30 function domain scores were also generally maintained from baseline; similarly, physical, emotional, and social function domains were maintained with IRd versus placebo-Rd, with slightly higher mean change from baseline scores at earlier time points with IRd. Findings from this double-blind study demonstrate that addition of ixazomib to Rd significantly improved efficacy while HRQoL was maintained, reflecting the limited additional toxicity seen with IRd versus placebo-Rd, and support the feasibility of long-term IRd administration.",
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AU - Leleu, Xavier

AU - Masszi, T.

AU - Bahlis, Nizar J.

AU - Viterbo, Luisa

AU - Baker, Bartrum

AU - Gimsing, Peter

AU - Maisnar, Vladimir

AU - Samoilova, Olga

AU - Rosiñol, Laura

AU - Langer, Christian

AU - Song, Kevin

AU - Izumi, Tohru

AU - Cleeland, Charles

AU - Berg, Deborah

AU - Lin, Huamao Mark

AU - Zhu, Yanyan

AU - Skacel, Tomas

AU - Moreau, Philippe

AU - Richardson, Paul G.

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