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Real-world effectiveness and safety of ixazomib-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma

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Abstract

Real-world data on regimens for relapsed/refractory multiple myeloma (RRMM) represent an important component of therapeutic decision-making. This multi-centric, retrospective, observational study conducted by the treating physicians evaluated the effectiveness and safety of ixazomib-lenalidomide-dexamethasone (IRd) in 155 patients who received ixazomib via early access programs in Greece, the UK, and the Czech Republic. Median age was 68 years; 17% had an Eastern Cooperative Oncology Group performance status ≥ 2; median number of prior therapies was 1 (range 1–7); 91%, 47%, and 17% had received prior bortezomib, thalidomide, and lenalidomide, respectively. Median duration of exposure to ixazomib was 9.6 months. Overall response rate was 74%, including 35% very good partial response or better (16% complete response). Median progression-free survival (PFS) was 27.6 months (27.6 and 19.9 months in patients with 1 or > 1 prior lines, respectively). IRd treatment for ≥ 6 months was associated with longer PFS (hazard ratio 0.06). Fourteen patients (9%) discontinued IRd due to adverse events/toxicity in the absence of disease progression. Peripheral neuropathy was reported in 35% of patients (3% grades 3–4). These findings support the results of the phase III TOURMALINE-MM1 trial in a broader real-world RRMM population.

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Acknowledgments

The authors acknowledge Steve Hill, PhD, of FireKite (an Ashfield Company, part of UDG Healthcare PLC) for medical writing support, which was funded by Takeda Pharmaceutical Company Limited, and complied with Good Publication Practice-3 (GPP3) guidelines (Battisti WP et al. Ann Intern Med 2015; 163: 461–464).

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Author notes

  1. Evangelos Terpos and Karthik Ramasamy have contibuted equally to this work.

Authors and Affiliations

  1. Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra General Hospital, 80 Vasilissis Sophias, 11528, Athens, Greece

    Evangelos Terpos, Ioannis Ntanasis-Stathopoulos, Maria Gavriatopoulou, Efstathios Kastritis & Meletios A. Dimopoulos

  2. Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK

    Karthik Ramasamy, Nadjoua Maouche, Grant D. Vallance & Jaimal Kothari

  3. NIHR BRC Blood Theme, Oxford, UK

    Karthik Ramasamy & Jaimal Kothari

  4. NIHR BRC Research Education and Training Group, Oxford, UK

    Nadjoua Maouche

  5. Department of Hemato-Oncology, University Hospital Olomouc, Olomouc, Czech Republic

    Jiri Minarik & Tomas Pika

  6. Department of Hematology, Theagenio Cancer Hospital, Thessaloniki, Greece

    Eirini Katodritou

  7. Department of Haematology, University Hospital Southampton NHS Foundation Trust, Southampton, UK

    Matthew W. Jenner

  8. Department of Hemato-Oncology, University Hospital Ostrava, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic

    Hana Plonkova, Tomas Jelinek & Roman Hajek

  9. Department of Hematology, Metaxa Cancer Hospital, Piraeus, Greece

    Maria Kotsopoulou

  10. Buckinghamshire Healthcare NHS Trust, Amersham, Bucks, UK

    Robin Aitchison

  11. EUCAN Medical Affairs, Takeda Pharmaceuticals International AG, Glattpark-Opfikon, Zurich, Switzerland

    Athanasios Zomas

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  1. Evangelos Terpos
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Contributions

ET, KR, NM, JM, IN-S, EKatod, MWJ, HP, MG, GDV, TP, MK, JK, TJ, EKastr, RA, MAD, and RH performed the research and collected the data. ET, KR, AZ, and RH analyzed the data. ET, KR, AZ, and RH wrote the paper. All authors reviewed and revised the paper and approved the submitted version.

Corresponding author

Correspondence to Evangelos Terpos.

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IN-S, EKatod, TP, MK, JK, and RA declare that they have no conflict of interest. ET reports honoraria from Abbvie, Amgen, BMS, and Takeda; honoraria and research funding from Janssen; and research funding from Genesis/Celgene, GSK, and is an SC member and a DMC member. KR reports honoraria from Amgen and Janssen and honoraria and research funding from Takeda and Celgene. NM received research funding from NIHR BRC Research Education and Training Group; honorarium, consultancy fees, speaker fees, conference attendance, and a grant from Takeda UK (17077); speaker fees from Celgene and Novartis; travel and accommodation to attend conferences from Janssen; and conference registration from Abbvie. JM reports honoraria from Amgen, Takeda, BMS, and Janssen and honoraria and research funding from Celgene. MWJ reports being an advisory board member and receiving speaker fees, travel, and accommodation to attend conferences from Takeda Oncology, Celgene, and Janssen. HP reports personal fees from Amgen. MG reports honoraria from Takeda and Amgen; steering committee for Karyopharm; and research funding from Novartis. GDV reports research funding from Takeda and Jazz Pharmaceuticals. TJ reports personal fees from Amgen, Celgene, Takeda, and Janssen. EKastr reports research funding and personal fees from Amgen and Janssen and personal fees from Takeda and Genesis Pharm. MAD reports consultancy, honoraria, and other from Amgen Inc., Celgene Corporation, Janssen Biotech Inc., Onyx Pharmaceuticals, an Amgen subsidiary, and Takeda Oncology; advisory committees for Amgen Inc., Celgene Corporation, Janssen Biotech Inc., Onyx Pharmaceuticals, an Amgen subsidiary, and Takeda Oncology; consultancy for and honoraria from Novartis; and research funding from Genesis Pharma. AZ is an employee of Takeda Oncology. RH reports consultancy, honoraria, and research funding from Janssen, BMS, and Celgene; consultancy, honoraria, membership on an entity’s board of directors or advisory committees, and research funding from Amgen and Takeda; consultancy and honoraria from Abbvie and Pharma MAR; and consultancy and research funding from Novartis.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study by their individual treating physician.

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Terpos, E., Ramasamy, K., Maouche, N. et al. Real-world effectiveness and safety of ixazomib-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma. Ann Hematol 99, 1049–1061 (2020). https://doi.org/10.1007/s00277-020-03981-z

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