Fredrik Schjesvold1,2, Hartmut Goldschmidt3, Vladimir Maisnar4, Ivan Spicka5, Neils Abildgaard6, Philip Rowlings7, Lauren Cain8, Dorothy Romanus9, Kaveri Suryanarayan10, Vincent Rajkumar11, Dawn Odom12, Ari Gnanasakthy13, Meletios Dimopoulos14. 1. Oslo Myeloma Center, Oslo University Hospital, Oslo, Norway. 2. KG Jebsen Center for B cell malignancies, University of Oslo, Oslo, Norway. 3. Department of Internal Medicine V, University Medical Hospital and National Center of Tumor Diseases, University of Heidelberg, Heidelberg, Germany. 4. Department of Medicine-Hematology, Charles University Hospital, Hradec Králové, Czech Republic. 5. Department of Hematology, Charles University, Prague, Czech Republic. 6. Department of Hematology, Odense University Hospital, University of Southern Denmark, Odense, Denmark. 7. Department of Hematology, School of Medicine & Public Health, University of Newcastle, Waratah, New South Wales, Australia. 8. Statistical and Quantitative Sciences, Takeda Pharmaceuticals, Cambridge, MA, USA. 9. Global Outcomes Research, Takeda Pharmaceuticals, Cambridge, MA, USA. 10. Oncology Clinical Research, Takeda Pharmaceuticals, Cambridge, MA, USA. 11. Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA. 12. Biostatistics, RTI Health Solutions, Research Triangle Park, NC, USA. 13. Patient-Centered Outcomes Assessment, RTI Health Solutions, Research Triangle Park, NC, USA. 14. Department of Clinical Therapeutics, Hematology & Medical Oncology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Abstract
OBJECTIVES:Health-related quality of life (HRQoL) is particularly important during maintenance therapy (MT) in newly diagnosed multiple myeloma post-transplant, when disease symptoms are limited. METHODS: We assessed HRQoL in patients randomised to 26 cycles of MT (ixazomib vs placebo) in TOURMALINE-MM3 (NCT02181413). RESULTS: The characteristics at study entry were well-balanced between ixazomib (n = 386) and placebo (n = 251) arms. At study entry, EORTC QLQ-C30 and MY20 scores were high for functional scales and low for symptom scales and were comparable with those of the general population. Changes in subscale scores across intervals, analysed over 30 four-week intervals using a linear mixed-effects model, were generally small and similar between arms for the EORTC QLQ-C30 Global Health Status/QoL, Physical Functioning, and Pain subscales and EORTC QLQ-MY20 Disease Symptoms subscale and Peripheral Neuropathy item. EORTC QLQ-C30 Nausea/Vomiting and Diarrhoea subscales were consistently worse for ixazomib than for placebo, in line with the ixazomib toxicity profile. Even when least-squares mean differences between arms were statistically significant, none reached the established minimal important clinical difference of 10 in multiple myeloma. CONCLUSIONS: In addition to improvement in progression-free survival with ixazomib, HRQoL was maintained in both arms. Active treatment with ixazomib did not have an adverse impact on HRQoL.
RCT Entities:
OBJECTIVES: Health-related quality of life (HRQoL) is particularly important during maintenance therapy (MT) in newly diagnosed multiple myeloma post-transplant, when disease symptoms are limited. METHODS: We assessed HRQoL in patients randomised to 26 cycles of MT (ixazomib vs placebo) in TOURMALINE-MM3 (NCT02181413). RESULTS: The characteristics at study entry were well-balanced between ixazomib (n = 386) and placebo (n = 251) arms. At study entry, EORTC QLQ-C30 and MY20 scores were high for functional scales and low for symptom scales and were comparable with those of the general population. Changes in subscale scores across intervals, analysed over 30 four-week intervals using a linear mixed-effects model, were generally small and similar between arms for the EORTC QLQ-C30 Global Health Status/QoL, Physical Functioning, and Pain subscales and EORTC QLQ-MY20 Disease Symptoms subscale and Peripheral Neuropathy item. EORTC QLQ-C30 Nausea/Vomiting and Diarrhoea subscales were consistently worse for ixazomib than for placebo, in line with the ixazomibtoxicity profile. Even when least-squares mean differences between arms were statistically significant, none reached the established minimal important clinical difference of 10 in multiple myeloma. CONCLUSIONS: In addition to improvement in progression-free survival with ixazomib, HRQoL was maintained in both arms. Active treatment with ixazomib did not have an adverse impact on HRQoL.
Authors: Evangelos Terpos; Joseph Mikhael; Roman Hajek; Ajai Chari; Sonja Zweegman; Hans C Lee; María-Victoria Mateos; Alessandra Larocca; Karthik Ramasamy; Martin Kaiser; Gordon Cook; Katja C Weisel; Caitlin L Costello; Jennifer Elliott; Antonio Palumbo; Saad Z Usmani Journal: Blood Cancer J Date: 2021-02-18 Impact factor: 11.037