Efficacy and Safety of Ixazomib Plus Lenalidomide and Dexamethasone Following Injectable PI-Based Therapy in Relapsed/Refractory Multiple Myeloma.

"Statements and Declarations Data-sharing statementThe datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants’ data supporting the results reported in this article, will be made available within three months from initial request, to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymization. Authorship contributionsStudy design: Yu ABE, Makoto SASAKI, Naoki TAKEZAKO, Takaaki CHOU, Takahiro YOSHIDA, Ikuo MORI, Tomohiro SHINOZAKI, Kenshi SUZUKI; Data acquisition: Yu ABE, Makoto SASAKI, Naoki TAKEZAKO, Shigeki ITO, Kazuhito SUZUKI, Hiroshi HANDA, Takaaki CHOU, Kenshi SUZUKI; Analyses (including statistical): Takahiro YOSHIDA, Ikuo MORI, Tomohiro SHINOZAKI; Interpretation of data: all; Manuscript writing, feedback, and revisions: all. Ethics approvalThe trial was designed by the steering committee members and the secondary sponsor (Takeda). The protocol was approved by the Certified Review Board and registered with the Ministry of Health, Labour and Welfare (Japan Registry of Clinical Trials). The trial was performed in accordance with the ethical standards specified in the 1964 Declaration of Helsinki and its later amendments. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. All patients provided written informed consent to participate in the study. Competing interestsYA: No conflict/s of interest to disclose.MS: Payment or honoraria was received from Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., and Sanofi for lectures, presentations, speaker’s bureaus, manuscript writing or educational events.NT: No conflict/s of interest to disclose.SI: Payment or honoraria was received from Takeda Pharmaceutical Co., Janssen, Sanofi, BMS, and Ono Pharmaceutical.KS: Honoraria for lectures was received from Takeda Pharmaceutical Co., Janssen Pharmaceutical K.K., and SanofiHH: Support for the presentation of the manuscript (e.g. funding, provision of study materials, medical writing, article processing charges etc.) was received from Takeda Pharmaceutical Co. Funding for grants was received from Takeda Pharmaceutical Co., BMS, Kyowa-Kirin, Chugai, and Nihon-Shinyaku. Consulting fees were received from Takeda Pharmaceutical Co., Janssen, BMS, Sanofi, and AbbVie. Payment or honoraria was received from Takeda Pharmaceutical Co., Janssen, BMS, Ezai, Sanofi, Ono Pharmaceutical, AbbVie, and Novartis.TC: No conflict/s of interest to disclose.TY: Employee of Takeda Pharmaceutical Co.IM: Employee of Takeda Pharmaceutical Co.TS: Consulting fees (statistical analyses review), and support for attending a steering committee meeting, were received from Takeda Pharmaceutical Co.KS: Consulting fees were received from Amgen, Takeda Pharmaceutical Co., and BMS. Payment or honoraria was received from Takeda Pharmaceutical Co., Ono Pharmaceutical, Amgen, Novartis, Sanofi, BMS, AbbVie and Janssen. Competing interests YA: No conflict/s of interest to disclose. MS: Payment or honoraria was received from Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., and Sanofi for lectures, presentations, speaker’s bureaus, manuscript writing or educational events. NT: No conflict/s of interest to disclose. SI: Payment or honoraria was received from Takeda Pharmaceutical Co., Janssen, Sanofi, BMS, and Ono Pharmaceutical. KS: Honoraria for lectures was received from Takeda Pharmaceutical Co., Janssen Pharmaceutical K.K., and Sanofi HH: Support for the presentation of the manuscript (e.g. funding, provision of study materials, medical writing, article processing charges etc.) was received from Takeda Pharmaceutical Co. Funding for grants was received from Takeda Pharmaceutical Co., BMS, Kyowa-Kirin, Chugai, and Nihon-Shinyaku. Consulting fees were received from Takeda Pharmaceutical Co., Janssen, BMS, Sanofi, and AbbVie. Payment or honoraria was received from Takeda Pharmaceutical Co., Janssen, BMS, Ezai, Sanofi, Ono Pharmaceutical, AbbVie, and Novartis. TC: No conflict/s of interest to disclose. TY: Employee of Takeda Pharmaceutical Co. IM: Employee of Takeda Pharmaceutical Co. TS: Consulting fees (statistical analyses review), and support for attending a steering committee meeting, were received from Takeda Pharmaceutical Co. KS: Consulting fees were received from Amgen, Takeda Pharmaceutical Co., and BMS. Payment or honoraria was received from Takeda Pharmaceutical Co., Ono Pharmaceutical, Amgen, Novartis, Sanofi, BMS, AbbVie and Janssen."

"Funding This study was funded by Takeda Pharmaceutical Co., Ltd."

"Trial registration number NCT03416374; Date of registration: January 31, 2018"