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 |
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| Authors: | Xavier Leleu Tamas 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 |
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| Institution: | 1. Department of Haematology, Hospital La Milétrie, and INSERM CIC 1402, Poitiers, France;2. Department of Hematology and Stem Cell Transplantation, St. István and St. László Hospital, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary;3. Southern Alberta Cancer Research Institute, University of Calgary, Calgary, Alberta, Canada;4. Servi?o de Onco‐Hematologia, Instituto Português de Oncologia do Porto Francisco Gentil, Entidade Pública Empresarial (IPOPFG, EPE), Porto, Portugal;5. Department of Haematology, Palmerston North Hospital, Palmerston North, Manawatu, New Zealand;6. Department of Hematology, University Hospital Rigshospitalet, Copenhagen, Denmark;7. 4th Department of Medicine ‐ Hematology, University Hospital, Hradec Kralove, Czech Republic;8. Nizhnii Novgorod Region Clinical Hospital, Nizhnii Novgorod, Russia;9. Department of Hematology, University of Barcelona, Barcelona, Spain;10. Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany;11. Division of Hematology, University of British Columbia, Vancouver, Canada;12. Department of Hematology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan;13. Department of Symptom Research, University of Texas M.D. Anderson Cancer Center, Houston, Texas;14. Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited;15. Department of Hematology, Charles University General Hospital, Prague, Czech Republic;16. Department of Hematology, University Hospital H?tel Dieu, Nantes, France;17. Department of Hematologic Oncology, Dana‐Farber Cancer Institute, Boston, Massachusetts |
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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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