A prospective, multicenter, observational study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in Japan.

"Declarations Ethics approvalThis study was approved by the institutional ethics committees of Nagoya City University Graduate School of Medical Sciences (Approval No.: 50–17-0002, 12 April 2018) and other participating institutes. This study was conducted in accordance with the ethical principles of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and complied with all applicable laws and regulations, including data privacy laws, and guidelines and regulations on conflicts of interest. Consent to participateWritten informed consent was obtained from all patients prior to any study procedures being undertaken. Competing interestsYuichi Horigome has received honoraria for lectures and advisory board fees from Janssen. Takahiro Kobayashi has received speaker fees from Ono Pharmaceutical, Bristol-Myers Squibb, Takeda, Fujimoto, Janssen, and Sanofi. Hiroshi Handa has received research grants from Takeda, Bristol-Myers Squibb, and Kyowa Kirin; consulting fees from Takeda, Janssen, and Bristol-Myers Squibb; lecture fees from Takeda, Janssen, Bristol-Myers Squibb, Ono Pharmaceutical, and Sanofi; meeting fees, medical writing fees, and the article processing charge from Takeda; and counselling fees from Japanese Society of Myeloma. Masahiro Abe has received honoraria from Takeda, Bristol-Myers Squibb, Janssen, Sanofi, Ono Pharmaceutical, and Daiichi Sankyo and is the President of the Japanese Society of Myeloma. Tadao Ishida has received grants from Janssen and Bristol-Myers Squibb; and honoraria from Ono Pharmaceutical, Janssen, Bristol-Myers Squibb, Takeda, and Sanofi. Shigeki Ito has received clinical trial contracts from Bristol-Myers Squibb; and lecture fees from Bristol-Myers Squibb and Takeda. Hiromi Iwasaki has received grants from Kyowa Kirin; and honoraria from Takeda, Daiichi Sankyo, SymBio, LSI Medience, AbbVie, Ono Pharmaceutical, Chugai, Janssen, Sanofi, AstraZeneca, and Kyowa Kirin. Junya Kuroda has received grants from Kyowa Kirin, Chugai, Daiichi Sankyo, Ono Pharmaceutical, Eisai, Taiho, Sumitomo, Shionogi, and Bristol-Myers Squibb; honoraria from Ono Pharmaceutical, Sanofi, Bristol-Myers Squibb, and Janssen; advisory board fees from Janssen, Bristol-Myers Squibb, Asahikasei Pharma, and Pfizer; and fees for other services from Bristol-Myers Squibb and Taiho. Hirohiko Shibayama has received fees for manuscript writing and for attending meetings from Takeda; grants from Ono Pharmaceutical and Bristol-Myers Squibb; consulting fees from Takeda, Fujimoto, Eisai, AstraZeneca, Janssen, AbbVie, and Sanofi; and honoraria from Takeda, Chugai, AstraZeneca, Ono Pharmaceutical, Janssen, and Sanofi. Kazutaka Sunami has received research funding from Ono Pharmaceutical, Celgene, AbbVie, Takeda, Sanofi, Bristol-Myers Squibb, GlaxoSmithKline, Chugai, Otsuka, and Janssen; and honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Takeda, and Sanofi. Hiroyuki Takamatsu has received grants from Bristol-Myers Squibb; consulting fees from SRL; and honoraria from Janssen, Ono Pharmaceutical, Sanofi, and Bristol-Myers Squibb. Hideto Tamura has received lecture fees from Sanofi, Bristol-Myers Squibb, Ono Pharmaceutical, Janssen, Chugai, and Takeda. Toshiaki Hayashi has received speaker fees from Takeda, Bristol-Myers Squibb, Ono Pharmaceutical, Sanofi, and Fujimoto. Kiwamu Akagi has received lecture fees from Merck Sharp & Dohme, Chugai, AstraZeneca, Bristol-Myers Squibb, Mochida, Taiho, and Roche; and advisory board fees from Takeda. Takahiro Maeda has received grants from Japan Society for the Promotion of Science, the Japanese Society of Hematology, Kyowa Kirin, and Takeda; and honoraria from Kyowa Kirin, Otsuka, Novartis, Sumitomo, Chugai, Takeda, Astellas Pharma Inc., and AbbVie. Tomohiro Shinozaki has received lecture fees from Santen Pharmaceutical, Novartis, and CMIC Holdings Co., Ltd.; and fees for attending meetings from Takeda. Shinsuke Iida has received grants from Takeda, Sanofi, Janssen, AbbVie, Novartis, Amgen, GlaxoSmithKline, Bristol-Myers Squibb, Daiichi Sankyo, Ono Pharmaceutical, Chugai, Otsuka, Celgene, and Alexion; consulting fees from Takeda, Janssen, Pfizer, AbbVie, Sanofi, Otsuka, GlaxoSmithKline, Regeneron, Bristol-Myers Squibb, and Novartis; and lecture fees from Janssen, Takeda, Bristol-Myers Squibb, Sanofi, and Ono Pharmaceutical. Takahiro Yoshida and Ikuo Mori are employees of Takeda Pharmaceutical Co. Ltd. Masaki Iino, Yoriko Harazaki, Yasushi Hiramatsu, Taiga Kuroi, Kazuki Tanimoto, and Kosei Matsue have no conflicts of interest to declare. Competing interests Yuichi Horigome has received honoraria for lectures and advisory board fees from Janssen. Takahiro Kobayashi has received speaker fees from Ono Pharmaceutical, Bristol-Myers Squibb, Takeda, Fujimoto, Janssen, and Sanofi. Hiroshi Handa has received research grants from Takeda, Bristol-Myers Squibb, and Kyowa Kirin; consulting fees from Takeda, Janssen, and Bristol-Myers Squibb; lecture fees from Takeda, Janssen, Bristol-Myers Squibb, Ono Pharmaceutical, and Sanofi; meeting fees, medical writing fees, and the article processing charge from Takeda; and counselling fees from Japanese Society of Myeloma. Masahiro Abe has received honoraria from Takeda, Bristol-Myers Squibb, Janssen, Sanofi, Ono Pharmaceutical, and Daiichi Sankyo and is the President of the Japanese Society of Myeloma. Tadao Ishida has received grants from Janssen and Bristol-Myers Squibb; and honoraria from Ono Pharmaceutical, Janssen, Bristol-Myers Squibb, Takeda, and Sanofi. Shigeki Ito has received clinical trial contracts from Bristol-Myers Squibb; and lecture fees from Bristol-Myers Squibb and Takeda. Hiromi Iwasaki has received grants from Kyowa Kirin; and honoraria from Takeda, Daiichi Sankyo, SymBio, LSI Medience, AbbVie, Ono Pharmaceutical, Chugai, Janssen, Sanofi, AstraZeneca, and Kyowa Kirin. Junya Kuroda has received grants from Kyowa Kirin, Chugai, Daiichi Sankyo, Ono Pharmaceutical, Eisai, Taiho, Sumitomo, Shionogi, and Bristol-Myers Squibb; honoraria from Ono Pharmaceutical, Sanofi, Bristol-Myers Squibb, and Janssen; advisory board fees from Janssen, Bristol-Myers Squibb, Asahikasei Pharma, and Pfizer; and fees for other services from Bristol-Myers Squibb and Taiho. Hirohiko Shibayama has received fees for manuscript writing and for attending meetings from Takeda; grants from Ono Pharmaceutical and Bristol-Myers Squibb; consulting fees from Takeda, Fujimoto, Eisai, AstraZeneca, Janssen, AbbVie, and Sanofi; and honoraria from Takeda, Chugai, AstraZeneca, Ono Pharmaceutical, Janssen, and Sanofi. Kazutaka Sunami has received research funding from Ono Pharmaceutical, Celgene, AbbVie, Takeda, Sanofi, Bristol-Myers Squibb, GlaxoSmithKline, Chugai, Otsuka, and Janssen; and honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Takeda, and Sanofi. Hiroyuki Takamatsu has received grants from Bristol-Myers Squibb; consulting fees from SRL; and honoraria from Janssen, Ono Pharmaceutical, Sanofi, and Bristol-Myers Squibb. Hideto Tamura has received lecture fees from Sanofi, Bristol-Myers Squibb, Ono Pharmaceutical, Janssen, Chugai, and Takeda. Toshiaki Hayashi has received speaker fees from Takeda, Bristol-Myers Squibb, Ono Pharmaceutical, Sanofi, and Fujimoto. Kiwamu Akagi has received lecture fees from Merck Sharp & Dohme, Chugai, AstraZeneca, Bristol-Myers Squibb, Mochida, Taiho, and Roche; and advisory board fees from Takeda. Takahiro Maeda has received grants from Japan Society for the Promotion of Science, the Japanese Society of Hematology, Kyowa Kirin, and Takeda; and honoraria from Kyowa Kirin, Otsuka, Novartis, Sumitomo, Chugai, Takeda, Astellas Pharma Inc., and AbbVie. Tomohiro Shinozaki has received lecture fees from Santen Pharmaceutical, Novartis, and CMIC Holdings Co., Ltd.; and fees for attending meetings from Takeda. Shinsuke Iida has received grants from Takeda, Sanofi, Janssen, AbbVie, Novartis, Amgen, GlaxoSmithKline, Bristol-Myers Squibb, Daiichi Sankyo, Ono Pharmaceutical, Chugai, Otsuka, Celgene, and Alexion; consulting fees from Takeda, Janssen, Pfizer, AbbVie, Sanofi, Otsuka, GlaxoSmithKline, Regeneron, Bristol-Myers Squibb, and Novartis; and lecture fees from Janssen, Takeda, Bristol-Myers Squibb, Sanofi, and Ono Pharmaceutical. Takahiro Yoshida and Ikuo Mori are employees of Takeda Pharmaceutical Co. Ltd. Masaki Iino, Yoriko Harazaki, Yasushi Hiramatsu, Taiga Kuroi, Kazuki Tanimoto, and Kosei Matsue have no conflicts of interest to declare."

"Funding This study was funded by Takeda Pharmaceutical Company Ltd."

"This was a non-interventional, multicenter, prospective, observational study conducted in Japan in patients with RRMM who were treated with IRd. The study was registered at ClinicalTrials.gov (identifier: NCT03433001) on 14 February 2018 and the Japan Pharmaceutical Information Center – Clinical Trials Information (identifier: JapicCTI-183860) on 09 February 2018. Patients were enrolled at 81 sites in Japan between April 2018 and May 2019. The observation period for each patient was from the start of IRd therapy until either 24 months after the enrollment date of the final patient, or until death or withdrawal of consent, whichever was earlier."