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ASCT for fit, older patients in Myeloma XI
received research funding from Celgene Corporation; has received research funding from Amgen and Merck Sharp and Dohme; and has received honoraria from Janssen. GJM has received research funding from Janssen; has provided consultancy services for and received honoraria from Bristol-Myers Squibb, Takeda, Roche, Amgen, GSK and Karyopharm; and has acted as a consultant for and received honoraria and research funding from Celgene Corporation. GHJ has provided consultancy and speakers bureau services for and received honoraria from Roche, Amgen, Janssen, and Merck Sharp and Dohme; and has provided consultancy and speakers bureau services for and received honoraria, travel sup- port and research funding from Celgene Corporation and Takeda. FED has received honoraria from Adaptive; has provided consul- tancy services for and received honoraria and research funding from Celgene Corporation; and has provided consultancy services for and received honoraria from Janssen, Oncopeptide, Roche, Sanofi, and Takeda.
Contributions
CP, DAC and FED designed this analysis; GJM, GHJ and FED were Chief Investigators of the Myeloma XI trial; CP, KDB, JRJ, MWJ, GC, MFK, RGO, GJM, GHJ and FED par- ticipated in the recruitment and management of patients; MFK, MTD, RGO and GJM coordinated the central laboratory inves- tigations; CP, DAC, TM and FED analyzed and interpreted the data for this analysis; CP, DAC and TM drafted the manuscript. All authors contributed to critically revising the manuscript and approved the final submitted version.
Acknowledgments
We thank all the patients at centers throughout the UK whose willingness to participate made this study possible. We are grate- ful to the UK National Cancer Research Institute Haematological Oncology Clinical Studies Group, UK Myeloma Research Alliance, and to all principal investigators, sub-investigators, and local center staff for their dedication and commitment to recruiting
patients to the study. We thank the members of the Myeloma XI Trial Steering Committee and Data Monitoring and Ethics Committee. The support of the Clinical Trials Research Unit at the University of Leeds was essential to the successful running of the study; we thank all their staff who have contributed, past and present. Central laboratory analysis was performed at the Institute of Immunology and Immunotherapy, University of Birmingham; the Institute of Cancer Research, London; and the Haematological Malignancy Diagnostic Service, St James’s University Hospital, Leeds. We are very grateful to the laboratory teams for their con- tribution to the study. We also acknowledge support from the National Institute of Health Biomedical Research Centre at the Royal Marsden Hospital and the Institute of Cancer Research.
Funding
Primary financial support was from Cancer Research UK (C1298/A10410). Unrestricted educational grants from Celgene Corporation, Amgen, and Merck Sharp and Dohme, and funding from Myeloma UK supported trial coordination and laboratory studies. The authors are solely responsible for the study design, data collection, data analysis and interpretation, writing, and decisions about publication submission; no funder had any role in these aspects of the trial. Trial data were accessible to all authors.
Data-sharing statement
De-identified participant data will be made available when all primary and secondary endpoints of the trial have been met. Any requests for trial data and supporting material (data dictionary, protocol, and statistical analysis plan) will be reviewed by the trial management group in the first instance. Only requests that have a methodologically sound basis and whose proposed use of the data has been approved by the independent trial steering committee will be considered. Proposals should be directed to the Chief Investigator responsible for trial governance, Prof. Graham Jackson in the first instance; to gain access, data requestors will need to sign a data access agreement.
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