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, 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

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.

© 2022 Wiley Periodicals LLC.

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