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G.H. Jackson et al.
sultancy for and honoraria from Glycomimetics and Bristol- Myers Squibb; consultancy and speakers bureau services for and honoraria from Sanofi; and consultancy and speakers bureau services for and honoraria and research funding rom Takeda, Celgene Corporation, Janssen and Amgen. MFK reports consult- ing for Chugai; consultancy for and honoraria from Janssen and Amgen; consultancy for and travel support from Takeda and Bristol-Myers Squibb; and consultancy for and honoraria and research funding from Celgene Corporation. MTD has equity ownership or membership on the board of directors or advisory committees of Abingdon Health. RGO has received honoraria and travel support from Takeda; provided consultancy services for and received travel support from Janssen; and acted as a consult- ant for and received honoraria and research funding from Celgene Corporation. WMG reports consultancy services for and research funding from Celgene Corporation; research funding from Amgen, Merck Sharp and Dohme and honoraria from Janssen. GJM reports research funding from Janssen; consultancy for and honoraria from Bristol-Myers Squibb, Takeda, Roche, Amgen, GlaxoSmith Kline and Karyopharm; and consultancy for and honoraria and research funding from Celgene Corporation.
Contributions
GHJ, FED, NHR and GJM were the chief investigators; GHJ, FED, NHR, WMG and GJM designed the trial and developed the protocol; DAC, AS and WMG developed and carried out the statistical analysis; GHJ, FED, CP, JRJ, BK, MG, CDW, KK, JL, DA, SS, MWJ, GC, NHR, MFK, RGO, and GJM partici- pated in recruitment of patients; MFK, MTD, RGO, and GJM coordinated the central laboratory investigations; CC and AW coordinated the data collection and regulatory and governance requirements; GHJ, FED, CP, DAC, AS, MFK, MTD, RGO, WMG and GJM analyzed and interpreted the data; GHJ, FED, CP, DAC, AS and GJM developed the first drafts of the manu- script. All authors contributed to the review and amendments of the manuscript for important intellectual content and approved the final version for submission.
Acknowledgments
We thank all the patients at centers throughout the UK whose willingness to participate made this study possible. We are grateful 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 lab- oratory 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 contribution 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. The authors received editorial support from Excerpta Medica, fund- ed by the University of Leeds.
Funding
The primary financial support was from Cancer Research UK [C1298/A10410]. Unrestricted educational grants from Celgene Corporation, Amgen, and Merck Sharp and Dohme, and fund- ing from Myeloma UK supported trial coordination and labora- tory studies. The authors are solely responsible for 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. The corresponding author had full access to all of the data and the final responsibility to submit for publication.
Data sharing statement
De-identified participant data will be made available when all trial primary and secondary endpoints 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 which have a methodologically sound proposal 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 corresponding author in the first instance; to gain access, data requestors will need to sign a data access agreement.
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