Page 322 - Haematologica Vol. 109 - July 2024

LETTER TO THE EDITOR
the applicant is required to sign an agreement for data sharing before data release to ensure that the patients’ data are de- identified. In case of any risk of re-identification on anonymized data despite measures to protect patients’ confidentiality, the data will not be shared. The patients’ informed consent will always be respected. If the anonymization process will provide futile data, Oncopeptides has the right to refuse the request. Oncopeptides will
References
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2. Engelhardt M, Ihorst G, Singh M, et al. Real-world evaluation of health-related quality of life in patients with multiple myeloma from Germany. Clin Lymphoma Myeloma Leuk. 2021;21(2):e160-e175.
3. Richardson PG, Oriol A, Larocca A, et al. Melflufen and dexamethasone in heavily pretreated relapsed and refractory multiple myeloma. J Clin Oncol. 2021;39(7):757-767.
4. Schjesvold FH, Dimopoulos MA, Delimpasi S, et al. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study. Lancet Haematol. 2022;9(2):e98-e110.
5. Sonneveld P, Richardson PG, Ludwig H, et al. Benefit versus risk assessment of melflufen and dexamethasone in relapsed/ refractory multiple myeloma: analyses from longer follow-up of the OCEAN and HORIZON studies. Clin Lymphoma Myeloma Leuk. 2023;23(9):P687-696.
6. Richardson PG, Bringhen S, Voorhees P, et al. Melflufen plus dexamethasone in relapsed and refractory multiple myeloma (O-12-M1): a multicentre, international, open-label, phase 1-2 study. Lancet Haematol. 2020;7(5):e395-e407.
7. Larocca A, Leleu X, Touzeau C, et al. Patient-reported outcomes in relapsed/refractory multiple myeloma treated with melflufen plus dexamethasone: analyses from the phase II HORIZON study. Br J Haematol. 2022;196(3):639-648.
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provide access to patient-level clinical trial analysis datasets in a secured environment upon execution of the data-sharing agreement. Oncopeptides will also provide the protocol, statistical analysis plan, and the clinical study report synopsis if needed. For additional information or requests for access to Oncopeptides’ clinical trial data for research purposes, please contact us at: medinfoglobal@oncopeptides.com.
9. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual. 3rd ed. Brussels: European Organisation for Research and Treatment of Cancer, 2001. https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual. pdf. Accessed October 20, 2023.
10. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365-376.
11. EuroQol G. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199-208. 12. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the
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13. Ojo AS, Araoye MO, Ali A, Sarma R. The impact of current
therapeutic options on the health-related quality of life of patients with relapse/refractory multiple myeloma: a systematic review of clinical studies. J Cancer Surviv. 2024; 18: 673-697
14. Terpos E, Dimopoulos MA, Boccadoro M, et al. Health-related quality of life in patients with relapsed/refractory multiple myeloma treated with pomalidomide and dexamethasone +/- subcutaneous daratumumab: patient-reported outcomes from the APOLLO trial. Am J Hematol. 2022;97(4):481-490.
15. Popat R, Lonial S, Lee HC, et al. DREAMM-2: belantamab mafodotin effect on disease symptoms and health-related quality of life in patients with relapsed/refractory multiple myeloma (RRMM). Presented at the European Hematology Association (EHA) Virtual Congress, 2020; Abstract EP1746. https://library.ehaweb.org/eha/2020/eha25th/294226/rakesh. popat.dreamm-2.belantamab.mafodotin.effect.on.disease. symptoms.and.html. Accessed October 18, 2023.
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