HEALTH-RELATED QUALITY OF LIFE (HRQOL) OUTCOMES OF ORAL IXAZOMIB MAINTENANCE THERAPY POST AUTOLOGOUS STEM CELL TRANSPLANT (ASCT) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM) FROM TOURMALINE-MM3
Author(s): ,
Fredrik Schjesvold
Affiliations:
Oslo Myeloma Center,Oslo University Hospital,Oslo,Norway;KG Jebsen Center for B cell malignancies,University of Oslo,Oslo,Norway
,
Hartmut Goldschmidt
Affiliations:
Department of Internal Medicine V,University Medical Hospital and National Center of Tumor Diseases, University of Heidelberg,Heidelberg,Germany
,
Vladimir Maisnar
Affiliations:
Fourth Department of Medicine—Hematology,FN and LF UK Hradec Králové,Hradec Králové,Czech Republic
,
Ivan Spicka
Affiliations:
Department of Hematology,Charles University,Prague,Czech Republic
,
Niels Abildgaard
Affiliations:
Department of Hematology,Odense University Hospital, University of Southern Denmark,Odense,Denmark
,
Philip Rowlings
Affiliations:
Department of Hematology,School of Medicine & Public Health, University of Newcastle,Waratah, NSW,Australia
,
Dawn Odom
Affiliations:
Biostatistics,RTI Health Solutions,Research Triangle Park, NC,United States
,
Ari Gnanasakthy
Affiliations:
Patient-Centered Outcomes Assessment,RTI Health Solutions,Research Triangle Park, NC,United States
,
Kaveri Suryanarayan
Affiliations:
Oncology Clinical Research,Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited,Cambridge, MA,United States
,
Lauren Cain
Affiliations:
Global Outcomes Research,Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited,Cambridge, MA,United States
,
Dorothy Romanus
Affiliations:
Global Outcomes Research,Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited,Cambridge, MA,United States
,
S. Vincent Rajkumar
Affiliations:
Division of Hematology, Department of Internal Medicine,Mayo Clinic,Rochester, MN,United States
Meletios A. Dimopoulos
Affiliations:
Hematology & Medical Oncology, Department of Clinical Therapeutics,National and Kapodistrian University of Athens, School of Medicine,Athens,Greece
EHA Library. Schjesvold F. Jun 14, 2019; 266425; PF626
Fredrik Schjesvold
Fredrik Schjesvold
Contributions
Abstract

Abstract: PF626

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
Maintenance therapy (MT) in NDMM has been increasingly used to prolong duration of response achieved by ASCT. TOURMALINE-MM3 is a phase 3, double-blind, placebo-controlled study, where ixazomib improved PFS, and is the first study to evaluate the impact of MT on HRQoL post ASCT in NDMM (Dimopoulos et al., Lancet 2019;393:253). HRQoL is an important consideration during MT in NDMM patients with minimal disease burden post ASCT (Anderson et al., Leukemia 2008;22:231).

Aims
To assess HRQoL in patients randomized to ixazomib vs. placebo MT in TOURMALINE-MM3.

Methods

In TOURMALINE-MM3, NDMM patients post ASCT were randomly assigned in a 3:2 ratio to oral ixazomib or matching placebo. HRQoL was assessed by EORTC QLQ-C30 (overall/subscale score range, 1-100) at screening, the start of every cycle (1-26), end of treatment, every 4 weeks until start of next line of therapy after progression and twice thereafter. MM-specific symptoms were assessed by EORTC QLQ-MY20 (subscale score range, 1-100) at screening, the start of every 3 cycles between cycles 1-25, end of treatment, every 4 weeks until start of next line of therapy after progression and twice thereafter. For both instruments, higher scores for global and functional domains indicate better HRQoL, while higher scores on symptom scales represent higher levels of symptomatology. Change from study entry in subscale scores, defined in terms of 30 four-week intervals, was analyzed using a linear mixed-effects model among patients who reported HRQoL outcomes at study entry and completed at least one post-study entry assessment. 

Results

Characteristics at study entry were well balanced between ixazomib (n=386) and placebo (n=251) arms; median age: 58 years; ECOG performance status 0-1: 97%; 79% had at least a very good partial response post ASCT at study entry. At study entry, least squares (LS) mean scores for ixazomib vs. placebo on the EORTC QLQ-C30 were: Global Health Status/QoL, 69.8 vs. 69.1; Physical Functioning, 82.1 vs. 82.0; Pain, 25.3 vs. 25.7; Nausea/Vomiting, 2.3 vs. 2.0; Diarrhea, 5.9 vs. 6.0; and on the EORTC QLQ-MY20 were: Disease Symptoms, 20.3 vs. 19.2; Peripheral Neuropathy, 25.0 vs. 25.6. Compliance with study assessments, averaged across cycles, was high in the treatment phase (≥94%) and similar between treatment groups.

Changes in subscale scores across the 4-week intervals were generally similar between the ixazomib and placebo groups, with treatment differences not reaching the established minimal important difference (MID) of 10 in MM (Kvam et al., Eur J Haematol 2011;87:330). LS mean (95% CI) score changes at interval 24 (week 96) for ixazomib vs. placebo on the EORTC QLQ-C30 included: Global Health Status/QoL, –0.4 (–3.4, 2.7) vs. 1.8 (–1.7, 5.2); Physical Functioning, 0.7 (–1.8, 3.1) vs. 3.0 (0.3, 5.8); Pain, 4.1 (0.5, 7.7) vs. –1.4 (–5.5, 2.7); and on the EORTC QLQ-MY20 were: Disease Symptoms, 5.1 (2.4, 7.9) vs. 0.8 (–2.3, 3.8); Peripheral Neuropathy, –0.7 (–5.1, 3.7) vs. –6.2 (–11.1, –1.3). EORTC QLQ-C30 Nausea/Vomiting and Diarrhea subscales, while consistently worse for ixazomib than placebo (LS mean [95% CI] change at interval 24, 5.0 [3.0, 7.0] vs. 1.0 [–1.3, 3.3] and 4.0 [1.1, 6.8] vs. 0.5 [–2.8, 3.8], respectively), were in line with the ixazomib toxicity profile; treatment differences did not exceed the MID.

Conclusion
In addition to improvements in PFS with ixazomib, HRQoL was maintained during the protocol-defined treatment period in both arms, and active treatment with ixazomib did not have an adverse impact on HRQoL.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Autologous hematopoietic stem cell transplantation, Maintenance, Myeloma, Quality of life

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