Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study

Vaishali Sanchorawala; Giovanni Palladini; Monique C. Minnema; Arnaud Jaccard; Hans C. Lee; Simon Gibbs; Peter Mollee; Christopher Venner; Jin Lu; Stefan Schönland; Moshe Gatt; Kenshi Suzuki; Kihyun Kim; María Teresa Cibeira; Meral Beksac; Edward Libby; Jason Valent; Vania Hungria; Sandy W. Wong; Michael Rosenzweig; Naresh Bumma; Dominique Chauveau; Katharine S. Gries; John Fastenau; Nam Phuong Tran; Xiang Qin; Sandra Y. Vasey; Brendan M. Weiss; Jessica Vermeulen; Kai Fai Ho; Giampaolo Merlini; Raymond L. Comenzo; Efstathios Kastritis; Ashutosh D. Wechalekar

doi:10.1002/ajh.26536

Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study

Vaishali Sanchorawala^*, Giovanni Palladini, Monique C. Minnema, Arnaud Jaccard, Hans C. Lee, Simon Gibbs, Peter Mollee, Christopher Venner, Jin Lu, Stefan Schönland, Moshe Gatt, Kenshi Suzuki, Kihyun Kim, María Teresa Cibeira, Meral Beksac, Edward Libby, Jason Valent, Vania Hungria, Sandy W. Wong, Michael RosenzweigNaresh Bumma, Dominique Chauveau, Katharine S. Gries, John Fastenau, Nam Phuong Tran, Xiang Qin, Sandra Y. Vasey, Brendan M. Weiss, Jessica Vermeulen, Kai Fai Ho, Giampaolo Merlini, Raymond L. Comenzo, Efstathios Kastritis, Ashutosh D. Wechalekar

^*Corresponding author for this work

Faculty of Medicine

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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 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.

Original language	American English
Pages (from-to)	719-730
Number of pages	12
Journal	American Journal of Hematology
Volume	97
Issue number	6
Early online date	16 Mar 2022
DOIs	https://doi.org/10.1002/ajh.26536
State	Published - 1 Jun 2022

Bibliographical 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.

Keywords

Amyloidosis/drug therapy
Antibodies, Monoclonal
Antineoplastic Combined Chemotherapy Protocols
Bortezomib
Cyclophosphamide
Dexamethasone
Humans
Immunoglobulin Light-chain Amyloidosis/drug therapy
Multiple Myeloma/drug therapy
Quality of Life
Treatment Outcome

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10.1002/ajh.26536

Cite this

Sanchorawala, V., Palladini, G., Minnema, M. C., Jaccard, A., Lee, H. C., Gibbs, S., Mollee, P., Venner, C., Lu, J., Schönland, S., Gatt, M., Suzuki, K., Kim, K., Cibeira, M. T., Beksac, M., Libby, E., Valent, J., Hungria, V., Wong, S. W., ... Wechalekar, A. D. (2022). Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study. American Journal of Hematology, 97(6), 719-730. https://doi.org/10.1002/ajh.26536

@article{8e6720d4331a41d5af915a8fa1e8d891,

title = "Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study",

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 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.",

keywords = "Amyloidosis/drug therapy, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Cyclophosphamide, Dexamethasone, Humans, Immunoglobulin Light-chain Amyloidosis/drug therapy, Multiple Myeloma/drug therapy, Quality of Life, Treatment Outcome",

author = "Vaishali Sanchorawala and Giovanni Palladini and Minnema, {Monique C.} and Arnaud Jaccard and Lee, {Hans C.} and Simon Gibbs and Peter Mollee and Christopher Venner and Jin Lu and Stefan Sch{\"o}nland and Moshe Gatt and Kenshi Suzuki and Kihyun Kim and Cibeira, {Mar{\'i}a Teresa} and Meral Beksac and Edward Libby and Jason Valent and Vania Hungria and Wong, {Sandy W.} and Michael Rosenzweig and Naresh Bumma and Dominique Chauveau and Gries, {Katharine S.} and John Fastenau and Tran, {Nam Phuong} and Xiang Qin and Vasey, {Sandra Y.} and Weiss, {Brendan M.} and Jessica Vermeulen and Ho, {Kai Fai} and Giampaolo Merlini and Comenzo, {Raymond L.} and Efstathios Kastritis and Wechalekar, {Ashutosh D.}",

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 Sch{\"o}nland 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. Mar{\'i}a 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: {\textcopyright} 2022 Wiley Periodicals LLC.",

year = "2022",

month = jun,

day = "1",

doi = "10.1002/ajh.26536",

language = "American English",

volume = "97",

pages = "719--730",

journal = "American Journal of Hematology",

issn = "0361-8609",

publisher = "Wiley-Liss Inc.",

number = "6",

}

Sanchorawala, V, Palladini, G, Minnema, MC, Jaccard, A, Lee, HC, Gibbs, S, Mollee, P, Venner, C, Lu, J, Schönland, S, Gatt, M, Suzuki, K, Kim, K, Cibeira, MT, Beksac, M, Libby, E, Valent, J, Hungria, V, Wong, SW, Rosenzweig, M, Bumma, N, Chauveau, D, Gries, KS, Fastenau, J, Tran, NP, Qin, X, Vasey, SY, Weiss, BM, Vermeulen, J, Ho, KF, Merlini, G, Comenzo, RL, Kastritis, E & Wechalekar, AD 2022, 'Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study', American Journal of Hematology, vol. 97, no. 6, pp. 719-730. https://doi.org/10.1002/ajh.26536

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. et al.
In: American Journal of Hematology, Vol. 97, No. 6, 01.06.2022, p. 719-730.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab

T2 - Results from the ANDROMEDA study

AU - Sanchorawala, Vaishali

AU - Palladini, Giovanni

AU - Minnema, Monique C.

AU - Jaccard, Arnaud

AU - Lee, Hans C.

AU - Gibbs, Simon

AU - Mollee, Peter

AU - Venner, Christopher

AU - Lu, Jin

AU - Schönland, Stefan

AU - Gatt, Moshe

AU - Suzuki, Kenshi

AU - Kim, Kihyun

AU - Cibeira, María Teresa

AU - Beksac, Meral

AU - Libby, Edward

AU - Valent, Jason

AU - Hungria, Vania

AU - Wong, Sandy W.

AU - Rosenzweig, Michael

AU - Bumma, Naresh

AU - Chauveau, Dominique

AU - Gries, Katharine S.

AU - Fastenau, John

AU - Tran, Nam Phuong

AU - Qin, Xiang

AU - Vasey, Sandra Y.

AU - Weiss, Brendan M.

AU - Vermeulen, Jessica

AU - Ho, Kai Fai

AU - Merlini, Giampaolo

AU - Comenzo, Raymond L.

AU - Kastritis, Efstathios

AU - Wechalekar, Ashutosh D.

N1 - 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.

PY - 2022/6/1

Y1 - 2022/6/1

N2 - 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 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.

AB - 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 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.

KW - Amyloidosis/drug therapy

KW - Antibodies, Monoclonal

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Bortezomib

KW - Cyclophosphamide

KW - Dexamethasone

KW - Humans

KW - Immunoglobulin Light-chain Amyloidosis/drug therapy

KW - Multiple Myeloma/drug therapy

KW - Quality of Life

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85127350368&partnerID=8YFLogxK

U2 - 10.1002/ajh.26536

DO - 10.1002/ajh.26536

M3 - Article

C2 - 35293006

AN - SCOPUS:85127350368

SN - 0361-8609

VL - 97

SP - 719

EP - 730

JO - American Journal of Hematology

JF - American Journal of Hematology

IS - 6

ER -

Health-related quality of life in patients with light chain amyloidosis treated with bortezomib, cyclophosphamide, and dexamethasone ± daratumumab: Results from the ANDROMEDA study

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Keywords

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