Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone in Asian patients with newly diagnosed AL amyloidosis: subgroup analysis of ANDROMEDA.

"Declarations Ethics approvalAn independent ethics committee or institutional review board approved the trial. The study protocol was conducted in accordance with the principals of the Declaration of Helsinki and the International Conference on Harmonisation guidelines on Good Clinical Practice. Consent to participateAll patients provided written informed consent. Competing interestsKS consulted for and received honoraria and research funding from Celgene and Amgen; consulted for and received honoraria from Takeda and Janssen; received honoraria and research funding from Bristol Myers Squibb; and received honoraria from Ono, Novartis, Sanofi, and AbbVie. ADW received honoraria from and served on a board of directors or advisory committees for Janssen, Takeda, Caelum, and Celgene. KK consulted for and received honoraria and research funding from Bristol Myers Squibb, Takeda, Amgen, Celgene, and Janssen. CS received honoraria from Sanofi, Bristol Myers Squibb, and Janssen. FZ is currently employed by Peking University First Hospital. SI received honoraria and research funding from Sanofi, Bristol Myers Squibb, Daiichi Sankyo, Takeda, Ono, Celgene, and Janssen; and received research funding from Merck, AbbVie, Kyowa Kirin, and Chugai. NK received honoraria from Janssen. NT, SYV, and BT are current employees of Janssen and hold equity in Johnson & Johnson. XQ is a current employee of Janssen. BMW was an employee of Janssen at the time of the study. RLC consulted for and received research funding from Prothena, Janssen, Takeda, and Karyopharm and consulted for Amgen, Sanofi, Unum, and Caelum. EK consulted for and received honoraria and research funding from Janssen and Amgen; consulted for and received honoraria from Genesis and Takeda; was reimbursed by Janssen, Genesis, and Takeda for travel, accommodations, and expenses; and consulted for Pfizer. JSK, TI, C-KM, ZC, XC, TF, H-JS, and JL had no relevant conflicts of interest to disclose. Competing interests KS consulted for and received honoraria and research funding from Celgene and Amgen; consulted for and received honoraria from Takeda and Janssen; received honoraria and research funding from Bristol Myers Squibb; and received honoraria from Ono, Novartis, Sanofi, and AbbVie. ADW received honoraria from and served on a board of directors or advisory committees for Janssen, Takeda, Caelum, and Celgene. KK consulted for and received honoraria and research funding from Bristol Myers Squibb, Takeda, Amgen, Celgene, and Janssen. CS received honoraria from Sanofi, Bristol Myers Squibb, and Janssen. FZ is currently employed by Peking University First Hospital. SI received honoraria and research funding from Sanofi, Bristol Myers Squibb, Daiichi Sankyo, Takeda, Ono, Celgene, and Janssen; and received research funding from Merck, AbbVie, Kyowa Kirin, and Chugai. NK received honoraria from Janssen. NT, SYV, and BT are current employees of Janssen and hold equity in Johnson & Johnson. XQ is a current employee of Janssen. BMW was an employee of Janssen at the time of the study. RLC consulted for and received research funding from Prothena, Janssen, Takeda, and Karyopharm and consulted for Amgen, Sanofi, Unum, and Caelum. EK consulted for and received honoraria and research funding from Janssen and Amgen; consulted for and received honoraria from Genesis and Takeda; was reimbursed by Janssen, Genesis, and Takeda for travel, accommodations, and expenses; and consulted for Pfizer. JSK, TI, C-KM, ZC, XC, TF, H-JS, and JL had no relevant conflicts of interest to disclose."

"Funding This study was sponsored by Janssen Research & Development, LLC. Medical writing and editorial support were provided by Grace Wang, PharmD, of Lumanity Communications Inc., and funded by Janssen Global Services, LLC."

"The study was approved by independent ethics committees or institutional review boards at each site and was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. All patients provided written informed consent. The study design and analyses were devised by the investigators and sponsor, and study data were collected by the investigators and their research teams. Final data analysis and verification of accuracy were conducted by Janssen. Investigators were not restricted by confidentiality agreements and had full access to all data. Writing assistance was funded by Janssen Global Services, LLC. The study was sponsored by Janssen Research & Development, LLC, and was registered at ClinicalTrials.gov (NCT03201965)."