Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma

Katja Weisel; Meletios Dimopoulos; Philippe Moreau; Munci Yagci; Alessandra Larocca; Abraham S. Kanate; Filiz Vural; Nicola Cascavilla; Supratik Basu; Peter Johnson; Peter Byeff; Marek Hus; Paula Rodríguez-Otero; Ercan Muelduer; Pekka Anttila; Patrick J. Hayden; Maria Theresa Krauth; Paulo Lucio; Dina Ben-Yehuda; Larisa Mendeleeva; Shien Guo; Xin Yu; Lara Grote; Tsvetan Biyukov; Sujith Dhanasiri; Paul Richardson

doi:10.1080/10428194.2020.1747066

Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma

Katja Weisel^*, Meletios Dimopoulos, Philippe Moreau, Munci Yagci, Alessandra Larocca, Abraham S. Kanate, Filiz Vural, Nicola Cascavilla, Supratik Basu, Peter Johnson, Peter Byeff, Marek Hus, Paula Rodríguez-Otero, Ercan Muelduer, Pekka Anttila, Patrick J. Hayden, Maria Theresa Krauth, Paulo Lucio, Dina Ben-Yehuda, Larisa MendeleevaShien Guo, Xin Yu, Lara Grote, Tsvetan Biyukov, Sujith Dhanasiri, Paul Richardson

^*Corresponding author for this work

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

10 Scopus citations

Abstract

In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.

Original language	American English
Pages (from-to)	1850-1859
Number of pages	10
Journal	Leukemia and Lymphoma
Volume	61
Issue number	8
DOIs	https://doi.org/10.1080/10428194.2020.1747066
State	Published - 2 Jul 2020
Externally published	Yes

Bibliographical note

Funding Information:
KW: advisory board for and honoraria from Amgen, Adaptive Biotech, Celgene, a Bristol Myers Squibb company, Bristol Myers Squibb, Janssen, Juno, Takeda, Sanofi and research funding from Amgen, Celgene, a Bristol Myers Squibb Company, Sanofi, Janssen; MD: honoraria, consulting fees, and lecture fees from Celgene, a Bristol Myers Squibb Company, Amgen, Takeda; PM: personal fees from Celgene, a Bristol Myers Squibb Company, Janssen; MY: nothing to disclose; AL: honoraria and personal fees from Amgen, honoraria, advisory board, and personal fees from Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Janssen, and advisory board for Takeda; ASK: nothing to disclose; FV: nothing to disclose; NC: nothing to disclose; SB: nothing to disclose; PJ: nothing to disclose; PB: stock ownership in Merck, Bristol Myers Squibb, Pfizer, Teva, Johnson & Johnson and honoraria from Merck, AstraZeneca; MH: nothing to disclose; PRO: personal fees, lectures, and advisory boards for Celgene, a Bristol Myers Squibb Company, Janssen and personal fees and advisory boards for Kite Pharma, AbbVie, Sanofi; EM: nothing to disclose; PA: nothing to disclose; PH: nothing to disclose; MTK: consultancy for and honoraria from Amgen, Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Takeda, Novartis, and Janssen; PL: advisory board for and honoraria from Amgen, Celgene, a Bristol Myers Squibb Company, Janssen, Takeda, Sanofi; DBY: nothing to disclose; LM: nothing to disclose; SG: consulting fees from Celgene, a Bristol Myers Squibb Company; XY: employee for and salary/compensation from Bristol Myers Squibb; LG: employment with Bristol Myers Squibb; TB: employment and equity ownership in Celgene International Sàrl, a Bristol Myers Squibb Company; SD: employment and equity ownership in Bristol Myers Squibb; PR: grants from Bristol Myers Squibb, grants and personal fees from Oncopeptides, Celgene, a Bristol Myers Squibb Company, Takeda, and personal fees from Karyopharm, Amgen, Janssen, Sanofi.

Funding Information:
This work was supported by Celgene Corporation, a Bristol Myers Squibb Company. The authors thank the patients and their families, as well as all participating clinical investigators. Medical writing support was provided by Nora Tu, PharmD, and Stephen Gilliver, PhD, of Evidera and was funded by Bristol Myers Squibb.

Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.

Keywords

HRQoL
Quality of life
bortezomib
dexamethasone
multiple myeloma
pomalidomide

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Dive into the research topics of 'Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma'. Together they form a unique fingerprint.

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Weisel, K., Dimopoulos, M., Moreau, P., Yagci, M., Larocca, A., Kanate, A. S., Vural, F., Cascavilla, N., Basu, S., Johnson, P., Byeff, P., Hus, M., Rodríguez-Otero, P., Muelduer, E., Anttila, P., Hayden, P. J., Krauth, M. T., Lucio, P., Ben-Yehuda, D., ... Richardson, P. (2020). Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma. Leukemia and Lymphoma, 61(8), 1850-1859. https://doi.org/10.1080/10428194.2020.1747066

@article{96664a0602374998b7adaa37202f0de2,

title = "Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma",

abstract = "In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.",

keywords = "HRQoL, Quality of life, bortezomib, dexamethasone, multiple myeloma, pomalidomide",

author = "Katja Weisel and Meletios Dimopoulos and Philippe Moreau and Munci Yagci and Alessandra Larocca and Kanate, {Abraham S.} and Filiz Vural and Nicola Cascavilla and Supratik Basu and Peter Johnson and Peter Byeff and Marek Hus and Paula Rodr{\'i}guez-Otero and Ercan Muelduer and Pekka Anttila and Hayden, {Patrick J.} and Krauth, {Maria Theresa} and Paulo Lucio and Dina Ben-Yehuda and Larisa Mendeleeva and Shien Guo and Xin Yu and Lara Grote and Tsvetan Biyukov and Sujith Dhanasiri and Paul Richardson",

note = "Funding Information: KW: advisory board for and honoraria from Amgen, Adaptive Biotech, Celgene, a Bristol Myers Squibb company, Bristol Myers Squibb, Janssen, Juno, Takeda, Sanofi and research funding from Amgen, Celgene, a Bristol Myers Squibb Company, Sanofi, Janssen; MD: honoraria, consulting fees, and lecture fees from Celgene, a Bristol Myers Squibb Company, Amgen, Takeda; PM: personal fees from Celgene, a Bristol Myers Squibb Company, Janssen; MY: nothing to disclose; AL: honoraria and personal fees from Amgen, honoraria, advisory board, and personal fees from Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Janssen, and advisory board for Takeda; ASK: nothing to disclose; FV: nothing to disclose; NC: nothing to disclose; SB: nothing to disclose; PJ: nothing to disclose; PB: stock ownership in Merck, Bristol Myers Squibb, Pfizer, Teva, Johnson & Johnson and honoraria from Merck, AstraZeneca; MH: nothing to disclose; PRO: personal fees, lectures, and advisory boards for Celgene, a Bristol Myers Squibb Company, Janssen and personal fees and advisory boards for Kite Pharma, AbbVie, Sanofi; EM: nothing to disclose; PA: nothing to disclose; PH: nothing to disclose; MTK: consultancy for and honoraria from Amgen, Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Takeda, Novartis, and Janssen; PL: advisory board for and honoraria from Amgen, Celgene, a Bristol Myers Squibb Company, Janssen, Takeda, Sanofi; DBY: nothing to disclose; LM: nothing to disclose; SG: consulting fees from Celgene, a Bristol Myers Squibb Company; XY: employee for and salary/compensation from Bristol Myers Squibb; LG: employment with Bristol Myers Squibb; TB: employment and equity ownership in Celgene International S{\`a}rl, a Bristol Myers Squibb Company; SD: employment and equity ownership in Bristol Myers Squibb; PR: grants from Bristol Myers Squibb, grants and personal fees from Oncopeptides, Celgene, a Bristol Myers Squibb Company, Takeda, and personal fees from Karyopharm, Amgen, Janssen, Sanofi. Funding Information: This work was supported by Celgene Corporation, a Bristol Myers Squibb Company. The authors thank the patients and their families, as well as all participating clinical investigators. Medical writing support was provided by Nora Tu, PharmD, and Stephen Gilliver, PhD, of Evidera and was funded by Bristol Myers Squibb. Publisher Copyright: {\textcopyright} 2020 Informa UK Limited, trading as Taylor & Francis Group.",

year = "2020",

month = jul,

day = "2",

doi = "10.1080/10428194.2020.1747066",

language = "American English",

volume = "61",

pages = "1850--1859",

journal = "Leukemia and Lymphoma",

issn = "1042-8194",

publisher = "Informa Healthcare",

number = "8",

}

Weisel, K, Dimopoulos, M, Moreau, P, Yagci, M, Larocca, A, Kanate, AS, Vural, F, Cascavilla, N, Basu, S, Johnson, P, Byeff, P, Hus, M, Rodríguez-Otero, P, Muelduer, E, Anttila, P, Hayden, PJ, Krauth, MT, Lucio, P, Ben-Yehuda, D, Mendeleeva, L, Guo, S, Yu, X, Grote, L, Biyukov, T, Dhanasiri, S & Richardson, P 2020, 'Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma', Leukemia and Lymphoma, vol. 61, no. 8, pp. 1850-1859. https://doi.org/10.1080/10428194.2020.1747066

Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma. / Weisel, Katja; Dimopoulos, Meletios; Moreau, Philippe et al.
In: Leukemia and Lymphoma, Vol. 61, No. 8, 02.07.2020, p. 1850-1859.

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

TY - JOUR

T1 - Health-related quality-of-life results from the phase 3 OPTIMISMM study

T2 - pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma

AU - Weisel, Katja

AU - Dimopoulos, Meletios

AU - Moreau, Philippe

AU - Yagci, Munci

AU - Larocca, Alessandra

AU - Kanate, Abraham S.

AU - Vural, Filiz

AU - Cascavilla, Nicola

AU - Basu, Supratik

AU - Johnson, Peter

AU - Byeff, Peter

AU - Hus, Marek

AU - Rodríguez-Otero, Paula

AU - Muelduer, Ercan

AU - Anttila, Pekka

AU - Hayden, Patrick J.

AU - Krauth, Maria Theresa

AU - Lucio, Paulo

AU - Ben-Yehuda, Dina

AU - Mendeleeva, Larisa

AU - Guo, Shien

AU - Yu, Xin

AU - Grote, Lara

AU - Biyukov, Tsvetan

AU - Dhanasiri, Sujith

AU - Richardson, Paul

N1 - Funding Information: KW: advisory board for and honoraria from Amgen, Adaptive Biotech, Celgene, a Bristol Myers Squibb company, Bristol Myers Squibb, Janssen, Juno, Takeda, Sanofi and research funding from Amgen, Celgene, a Bristol Myers Squibb Company, Sanofi, Janssen; MD: honoraria, consulting fees, and lecture fees from Celgene, a Bristol Myers Squibb Company, Amgen, Takeda; PM: personal fees from Celgene, a Bristol Myers Squibb Company, Janssen; MY: nothing to disclose; AL: honoraria and personal fees from Amgen, honoraria, advisory board, and personal fees from Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Janssen, and advisory board for Takeda; ASK: nothing to disclose; FV: nothing to disclose; NC: nothing to disclose; SB: nothing to disclose; PJ: nothing to disclose; PB: stock ownership in Merck, Bristol Myers Squibb, Pfizer, Teva, Johnson & Johnson and honoraria from Merck, AstraZeneca; MH: nothing to disclose; PRO: personal fees, lectures, and advisory boards for Celgene, a Bristol Myers Squibb Company, Janssen and personal fees and advisory boards for Kite Pharma, AbbVie, Sanofi; EM: nothing to disclose; PA: nothing to disclose; PH: nothing to disclose; MTK: consultancy for and honoraria from Amgen, Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Takeda, Novartis, and Janssen; PL: advisory board for and honoraria from Amgen, Celgene, a Bristol Myers Squibb Company, Janssen, Takeda, Sanofi; DBY: nothing to disclose; LM: nothing to disclose; SG: consulting fees from Celgene, a Bristol Myers Squibb Company; XY: employee for and salary/compensation from Bristol Myers Squibb; LG: employment with Bristol Myers Squibb; TB: employment and equity ownership in Celgene International Sàrl, a Bristol Myers Squibb Company; SD: employment and equity ownership in Bristol Myers Squibb; PR: grants from Bristol Myers Squibb, grants and personal fees from Oncopeptides, Celgene, a Bristol Myers Squibb Company, Takeda, and personal fees from Karyopharm, Amgen, Janssen, Sanofi. Funding Information: This work was supported by Celgene Corporation, a Bristol Myers Squibb Company. The authors thank the patients and their families, as well as all participating clinical investigators. Medical writing support was provided by Nora Tu, PharmD, and Stephen Gilliver, PhD, of Evidera and was funded by Bristol Myers Squibb. Publisher Copyright: © 2020 Informa UK Limited, trading as Taylor & Francis Group.

PY - 2020/7/2

Y1 - 2020/7/2

N2 - In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.

AB - In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.

KW - HRQoL

KW - Quality of life

KW - bortezomib

KW - dexamethasone

KW - multiple myeloma

KW - pomalidomide

UR - http://www.scopus.com/inward/record.url?scp=85084198557&partnerID=8YFLogxK

U2 - 10.1080/10428194.2020.1747066

DO - 10.1080/10428194.2020.1747066

M3 - Article

C2 - 32268815

AN - SCOPUS:85084198557

SN - 1042-8194

VL - 61

SP - 1850

EP - 1859

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

IS - 8

ER -

Weisel K, Dimopoulos M, Moreau P, Yagci M, Larocca A, Kanate AS et al. Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma. Leukemia and Lymphoma. 2020 Jul 2;61(8):1850-1859. doi: 10.1080/10428194.2020.1747066

Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma

Abstract

Bibliographical note

Keywords

UN SDGs

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