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.

4th Department of Medicine Hematology University Hospital Hradec Kralove Czech Republic

Department of Haematology Hospital La Milétrie and INSERM CIC 1402 Poitiers France

Department of Haematology Palmerston North Hospital Palmerston North Manawatu New Zealand

Department of Hematologic Oncology Dana Farber Cancer Institute Boston Massachusetts

Department of Hematology and Stem Cell Transplantation St István and St László Hospital 3rd Department of Internal Medicine Semmelweis University Budapest Hungary

Department of Hematology Charles University General Hospital Prague Czech Republic

Department of Hematology Tochigi Cancer Center Utsunomiya Tochigi Japan

Department of Hematology University Hospital Hôtel Dieu Nantes France

Department of Hematology University Hospital Rigshospitalet Copenhagen Denmark

Department of Hematology University of Barcelona Barcelona Spain

Department of Internal Medicine 3 University Hospital of Ulm Ulm Germany

Department of Symptom Research University of Texas M D Anderson Cancer Center Houston Texas

Division of Hematology University of British Columbia Vancouver Canada

Millennium Pharmaceuticals Inc Cambridge Massachusetts a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

Nizhnii Novgorod Region Clinical Hospital Nizhnii Novgorod Russia

Serviço de Onco Hematologia Instituto Português de Oncologia do Porto Francisco Gentil Entidade Pública Empresarial Porto Portugal

Southern Alberta Cancer Research Institute University of Calgary Calgary Alberta Canada

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