Page 321 - Haematologica Vol. 109 - July 2024

LETTER TO THE EDITOR
Hematology and Oncology, University Hospital Brno, Babak Myeloma Group, Faculty of Medicine, Masaryk University, Brno, Czech Republic; 8First Department of Medicine - Department of Hematology, First Faculty of Medicine, Charles University and General Hospital in Prague, Prague, Czech Republic; 9Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece; 10Department of Internal Medicine and Hematology, Semmelweis University, Budapest, Hungary; 11National Research Center for Hematology, Moscow, Russia; 12Oncopeptides AB, Stockholm, Sweden; 13Hospital Clínico Universitario de Salamanca/IBSAL/CIC, Salamanca, Spain; 14Dana- Farber Cancer Institute, Boston, MA, USA and 15Erasmus MC Cancer Institute, Rotterdam, the Netherlands
Correspondence:
F.H. SCHJESVOLD - fredrikschjesvold@gmail.com
https://doi.org/10.3324/haematol.2023.284635
Received: December 21, 2023. Accepted: February 19, 2024. Early view: February 29, 2024.
©2024 Ferrata Storti Foundation Published under a CC BY-NC license
Disclosures
FHS has received grants or contracts from Celgene, GlaxoSmithKline, Janssen, Oncopeptides, Targovax, and Sanofi; has received payment or honoraria for lectures or speakers’ bureau participation from AbbVie, Amgen, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Janssen, Novartis, Oncopeptides, Pfizer, Sanofi, SkylineDX, and Takeda; has served on a data safety monitoring or advisory board for AbbVie, Celgene, GlaxoSmithKline, Janssen, Oncopeptides, Sanofi, and Takeda. HL has received research grants from Sanofi and Amgen; has served on data monitoring committees for GSK, Janssen, and Takeda; and has received payment or honoraria for speakers’ bureau participation from Pfizer, BMS, Janssen, Amgen, and Sanofi. SD has received payment or honoraria for speakers’ bureau participation from and served on an advisory board for Amgen, GlaxoSmithKline, Janssen, Pfizer, Sanofi, Sobi, and Takeda. DC has received travel support from Genesis Biopharma and Accord Healthcare. IS has received consulting fees from and served on a data monitoring or advisory board for Amgen, Bristol Myers Squibb, Celgene, Janssen, Novartis, PharmaMar, Sanofi, and Takeda; has received payment or honoraria for lectures or speakers’ bureau participation from Amgen, Bristol Myers Squibb, Celgene, Janssen, Sanofi, and Takeda; and has received meeting and/or travel support from Amgen, Bristol Myers Squibb, Celgene, and Janssen. M-AD has received payment or honoraria for advisory board participation from Amgen, BeiGene, Bristol Myers Squibb, BeiGene, Inc, GSK, Janssen, Menarini, Regeneron, Sanofi, and Takeda. TM has received payment or honoraria for advisory board participation from AbbVie, Janssen- Cilag, Novartis, Pfizer, and Sanofi. AS, SN, and NAB are employees of
and receive stock or stock options from Oncopeptides. MT is a consultant of and receives stock or stock options from Oncopeptides. M-VM has received payment or honoraria for lectures or speakers’ bureau participation from Amgen, Bristol Myers Squibb/ Celgene, GlaxoSmithKline, Janssen, Pfizer, Sanofi, and Takeda and has served on a data safety monitoring or advisory board for Amgen, bluebird bio, Bristol Myers Squibb/Celgene, GlaxoSmithKline, Janssen, Oncopeptides, Pfizer, Regeneron, Sanofi, and Takeda. PGR has served on advisory committees for Amgen, Bristol Myers Squibb/Celgene, GlaxoSmithKline, Karyopharm, Oncopeptides, Regeneron, and Sanofi and has received research grants from Bristol Myers Squibb/Celgene Karyopharm, Oncopeptides, and Takeda. PS has received grants or contracts from Amgen, Celgene, Janssen, Takeda, and SkylineDx. PR, NGC, LP, and WT have no competing interests to disclose.
Contributions
The study sponsor, Oncopeptides AB, conceptualized and designed the OCEAN study in collaboration with FSH, M-AD, M-VM, PGR, and PS. Patients’ data were collected by study site investigators. Data were analyzed by AS, MT, and SN. All authors had access to the data, participated in the interpretation of the data, took part in drafting and revising the manuscript, and approved the final version before submission.
Acknowledgments
The authors would like to thank the patients and their families for participating in this trial, and the trial investigators and coordinators for their contributions to the trial. We thank Jayasri Srinivasan, MD, MBA, and Swati Ghatpande, PhD, of Team 9 Science for providing medical writing assistance under the guidance of the authors, which was funded by Oncopeptides AB in accordance with Good Publications Practice (GPP) 2022 guidelines.
Funding
Funding for the study (ClinicalTrials.gov identifier: NCT03151811) and for editorial assistance was provided by Oncopeptides AB.
Data-sharing statement
Oncopeptides is committed to sharing clinical study data with qualified researchers to enable enhancement of public health. As such, Oncopeptides will share anonymized patient-level data on request or if required by law or regulation. Qualified scientific and medical researchers can request patient-level data for studies of Oncopeptides’ pharmaceutical substances listed on ClinicalTrials. gov and approved by health authorities in the USA and the European Union. Patient-level data for studies of newly approved pharmaceutical substances or indications can be requested 9 months after approval by the US Food and Drug Administration and European Medicines Agency. Such requests are assessed at Oncopeptides’ discretion, and the decisions depend on the scientific merit of the proposed request, data availability, and the purpose of the proposal. The applicants should be willing to submit both positive and negative findings to a scientific journal. If Oncopeptides agrees to share clinical data for research purposes,
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