Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: the TOURMALINE-MM3 trial
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-...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2020
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| In: |
European journal of haematology
Year: 2019, Volume: 104, Issue: 5, Pages: 443-458 |
| ISSN: | 1600-0609 |
| DOI: | 10.1111/ejh.13379 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/ejh.13379 Verlag, lizenzpflichtig, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/ejh.13379 
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| Author Notes: | Fredrik Schjesvold, Hartmut Goldschmidt, Vladimir Maisnar, Ivan Spicka, Neils Abildgaard, Philip Rowlings, Lauren Cain, Dorothy Romanus, Kaveri Suryanarayan, Vincent Rajkumar, Dawn Odom, Ari Gnanasakthy, Meletios Dimopoulos |
| Summary: | 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. |
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| Item Description: | First published: 26 December 2019 Gesehen am 04.08.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1600-0609 |
| DOI: | 10.1111/ejh.13379 |