Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: results from the ANDROMEDA study
Sanchorawala, Vaishali; Palladini, Giovanni; Minnema, Monique C; Jaccard, Arnaud; Lee, Hans C; Gibbs, Simon; Mollee, Peter; Venner, Christopher; Lu, Jin; Schönland, Stefan; Gatt, Moshe; Suzuki, Kenshi; Kim, Kihyun; Cibeira, M Teresa; Beksac, Meral; Libby, Edward; Valent, Jason; Hungria, Vania; Wong, Sandy W; Rosenzweig, Michael; Bumma, Naresh; Chauveau, Dominique; Gries, Katharine S; Fastenau, John; Tran, Nam Phuong; Qin, Xiang; Vasey, Sandra Y; Weiss, Brendan M; Vermeulen, Jessica; Ho, Kai Fai; Merlini, Giampaolo; Comenzo, Raymond L; Kastritis, Efstathios; Wechalekar, Ashutosh D
(2022) American Journal of Hematology, volume 97, issue 6, pp. 719 - 730
(Article)
Abstract
In the phase 3 ANDROMEDA trial, patients treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone (D-VCd) had significantly higher rates of organ and hematologic response compared with patients who received VCd alone. Here, we present patient-reported outcomes (PROs) from the ANDROMEDA trial. PROs were assessed through cycle 6 using three standardized
... read more
questionnaires. Treatment effect through cycle 6 was measured by a repeated-measures, mixed-effects model. The magnitude of changes in PROs versus baseline was generally low, but between-group differences favored the D-VCd group. Results were generally consistent irrespective of hematologic, cardiac, or renal responses. More patients in the D-VCd group experienced meaningful improvements in PROs; median time to improvement was more rapid in the D-VCd group versus the VCd group. After cycle 6, patients in the D-VCd group received daratumumab monotherapy and their PRO assessments continued, with improvements in health-related quality of life (HRQoL) reported through cycle 19. PROs of subgroups with renal and cardiac involvement were consistent with those of the intent-to-treat population. These results demonstrate that the previously reported clinical benefits of D-VCd were achieved without decrement to patients' HRQoL and provide support of D-VCd in patients with AL amyloidosis.
show less
Download/Full Text
The full text of this publication is not available.
Keywords: Hematology, Journal Article
ISSN: 0361-8609
Publisher: Wiley-Liss Inc.
Note: Funding Information: The ANDROMEDA study was funded by Janssen Research & Development, LLC. Editorial and medical writing support was provided by Corey Eagan, MPH, of Eloquent Scientific Solutions, and was funded by Janssen Global Services, LLC. Funding information Funding Information: Vaishali Sanchorawala has received research funding from Celgene, Takeda, Janssen, Prothena, Caelum, Oncopeptides, Karyopharm, and Sorrento, is a Board or Advisory Committee member for Janssen, Prothena, Abbvie, Caelum, Regeneron, and Proclara, and has received honoraria from Pfizer. Giovanni Palladini is a Board or Advisory Committee member for Janssen and receives honoraria from Janssen, Siemens, and Pfizer. Monique C. Minnema is a consultant for Alnylam, Kite/Gilead, BMS, and Janssen‐Cilag and has received travel expenses from Celgene. Arnaud Jaccard has received honoraria from Abbvie and Pfizer and is a Board or Advisory Committee member for Janssen. Hans C. Lee is a consultant for Bristol Myers Squibb, Celgene, Genentech, Janssen, Karyopharm, Legend Biotech, GlaxoSmithKline, Sanofi, Oncopeptides, Takeda, and Amgen and has received research funding from Janssen, GlaxoSmithKline, Takeda, and Amgen. Simon Gibbs is a consultant for and has received honoraria from Janssen, Celgene, Amgen, Takeda, BMS, and Pfizer, and is a consultant for Abbvie. Peter Mollee has received research funding from Janssen and Pfizer and is a Board or Advisory Committee member for Amgen, BMS, Janssen, Caelum, EUSA, Pfizer, SkylineDx, and Takeda. Christopher Venner has received honoraria from Janssen, Amgen, and Takeda and has received research funding from Celgene and Amgen. Stefan Schönland has received honoraria from Janssen, Pfizer, Takeda, and Prothena has received research funding from Janssen and Sanofi, and has received travel grants from Takeda and Prothena. Kenshi Suzuki has received honoraria from Bristol Myers Squibb, Celgene, Amgen, Takeda, ONO, Novartis, Sanofi, Abie, and Janssen, has received research funding from Bristol Myers Squibb, Celgene, and Amgen, and is a consultant for Celgene, Amgen, Takeda, and Janssen. Kihyun Kim is a consultant for and has received honoraria and research funding from Janssen and BMS. María Teresa Cibeira is a consultant for and has received honoraria from Janssen, Amgen, Akcea, and Celgene. Meral Beksac is a Board or Advisory Committee member for Amgen, BMS, Janssen, Sanofi, Oncopeptides, and Takeda. Edward Libby is a consultant for Janssen and has received research funding from Janssen, Genentech, BMS, and GSK. Jason Valent is on the Speakers' Bureau for Celgene, Takeda, and Amgen and has received clinical trial funding from Caelum Biosciences. Vania Hungria has received honoraria from Abbie, Amgen, BMS, Celgene, Janssen, Sanofi, and Takeda, is a Board or Advisory Committee member for and has received travel expenses from Amgen, BMS, Celgene, and Janssen, and has received travel expenses from Sanofi. Sandy W. Wong is a consultant for Amgen and Dren Biosciences, has received research funding from Genentech, Fortis, Janssen, GlaxoSmithKline, Caelum, and BMS, and is a Board or Advisory Committee member for Sanofi. Michael Rosenzweig is a consultant for Janssen and is a Speakers' Bureau member for Janssen, Bristol Myers Squibb, Akcea, Takeda, and Oncopeptides. Naresh Bumma is a Speakers' Bureau member for Amgen and Sanofi and is a consultant for Janssen, Oncopeptides, and Sanofi. Katharine S. Gries, John Fastenau, NamPhuong Tran, Xiang Qin, and Sandra Y. Vasey, are employees of Janssen. Brendan M. Weiss was an employee of Janssen at the time this research was conducted. Kai Fai Ho is a consultant for Janssen, Emalex Biosciences, and DRG Abacus. Raymond L. Comenzo has received research funding from Janssen, Caelum, Alnylam, and Prothena and receives royalties for patent WO2016187546A1. Efstathios Kastritis is a consultant for and has received research funding from Amgen, Janssen, and Pfizer and has received honoraria from Amgen, Genesis Pharma, Janssen, Takeda, and Pfizer. Ashutosh D. Wechalekar is a consultant for Janssen, Alexion, and AstraZeneca, has received honoraria from Celgene and Takeda, has received research funding from Amgen, and has received clinical trial funding from Caelum Biosciences. Jin Lu, Moshe Gatt, Dominique Chauveau, and Giampaolo Merlini have no conflicts of interest to disclose. Publisher Copyright: © 2022 Wiley Periodicals LLC.
(Peer reviewed)