Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial

Standard

Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. / Weisel, Katja; Dimopoulos, Meletios; Song, Kevin W; Moreau, Philippe; Palumbo, Antonio; Belch, Andrew; Schey, Stephen; Sonneveld, Pieter; Sternas, Lars; Yu, Xin; Amatya, Ramesh; Gibson, Craig J; Zaki, Mohamed; Jacques, Christian; San Miguel, Jesus.

in: CL LYMPH MYELOM LEUK, Jahrgang 15, Nr. 9, 09.2015, S. 519-30.

Publikationen: SCORING: Beitrag in Fachzeitschrift/ZeitungSCORING: ZeitschriftenaufsatzForschungBegutachtung

Harvard

Weisel, K, Dimopoulos, M, Song, KW, Moreau, P, Palumbo, A, Belch, A, Schey, S, Sonneveld, P, Sternas, L, Yu, X, Amatya, R, Gibson, CJ, Zaki, M, Jacques, C & San Miguel, J 2015, 'Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial', CL LYMPH MYELOM LEUK, Jg. 15, Nr. 9, S. 519-30. https://doi.org/10.1016/j.clml.2015.05.007

APA

Weisel, K., Dimopoulos, M., Song, K. W., Moreau, P., Palumbo, A., Belch, A., Schey, S., Sonneveld, P., Sternas, L., Yu, X., Amatya, R., Gibson, C. J., Zaki, M., Jacques, C., & San Miguel, J. (2015). Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. CL LYMPH MYELOM LEUK, 15(9), 519-30. https://doi.org/10.1016/j.clml.2015.05.007

Vancouver

Bibtex

@article{2aec7ef8c93d4e60897f8ceedafd35e2,
title = "Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial",
abstract = "BACKGROUND: Health-related quality of life (HRQoL) is an important element for consideration in treatment decisions in patients with relapsed/refractory multiple myeloma (RRMM). The pivotal MM-003 (A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone vs. High-Dose Dexamethasone in Patients With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study [NIMBUS]) randomized, open-label, multicenter, phase III trial demonstrated improved progression-free survival (PFS) and prolonged overall survival (OS) with pomalidomide (POM) plus low-dose dexamethasone (POM + LoDEX) versus high-dose dexamethasone (HiDEX) in patients with RRMM in whom lenalidomide (LEN) and bortezomib (BORT) had failed. MM-003 also investigated HRQoL as a predefined secondary end point.PATIENTS AND METHODS: Recruited patients (n = 455) were refractory to their last treatment and had failed LEN and BORT after ≥ 2 consecutive cycles of each (alone or in combination). Eight clinically relevant and validated HRQoL domains from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-MY20, and EQ-5D questionnaires were selected for analysis. Time to symptom worsening based on minimally important differences (MIDs) was calculated.RESULTS: Clinically meaningful improvements in HRQoL as determined by MIDs, regression analyses, and best response analyses were observed more frequently in patients receiving POM + LoDEX than in those receiving HiDEX. POM + LoDEX significantly extended median time to clinically meaningful worsening in HRQoL versus HiDEX in 4 HRQoL domains and demonstrated a trend in an additional 3 domains. Patients in the HiDEX arm experienced earlier HRQoL deterioration compared with those in the POM + LoDEX arm in each domain analyzed.CONCLUSION: POM + LoDEX offer good clinical outcomes that lead to improved and prolonged HRQoL compared with HiDEX in patients with RRMM and end-stage disease.",
keywords = "Aged, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Dexamethasone, Disease Progression, Disease-Free Survival, Drug Resistance, Neoplasm, Female, Humans, Lenalidomide, Male, Multiple Myeloma, Neoplasm Recurrence, Local, Quality of Life, Thalidomide, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "Katja Weisel and Meletios Dimopoulos and Song, {Kevin W} and Philippe Moreau and Antonio Palumbo and Andrew Belch and Stephen Schey and Pieter Sonneveld and Lars Sternas and Xin Yu and Ramesh Amatya and Gibson, {Craig J} and Mohamed Zaki and Christian Jacques and {San Miguel}, Jesus",
note = "Copyright {\textcopyright} 2015 Elsevier Inc. All rights reserved.",
year = "2015",
month = sep,
doi = "10.1016/j.clml.2015.05.007",
language = "English",
volume = "15",
pages = "519--30",
journal = "CL LYMPH MYELOM LEUK",
issn = "2152-2650",
publisher = "Cancer Media Group",
number = "9",

}

RIS

TY - JOUR

T1 - Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial

AU - Weisel, Katja

AU - Dimopoulos, Meletios

AU - Song, Kevin W

AU - Moreau, Philippe

AU - Palumbo, Antonio

AU - Belch, Andrew

AU - Schey, Stephen

AU - Sonneveld, Pieter

AU - Sternas, Lars

AU - Yu, Xin

AU - Amatya, Ramesh

AU - Gibson, Craig J

AU - Zaki, Mohamed

AU - Jacques, Christian

AU - San Miguel, Jesus

N1 - Copyright © 2015 Elsevier Inc. All rights reserved.

PY - 2015/9

Y1 - 2015/9

N2 - BACKGROUND: Health-related quality of life (HRQoL) is an important element for consideration in treatment decisions in patients with relapsed/refractory multiple myeloma (RRMM). The pivotal MM-003 (A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone vs. High-Dose Dexamethasone in Patients With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study [NIMBUS]) randomized, open-label, multicenter, phase III trial demonstrated improved progression-free survival (PFS) and prolonged overall survival (OS) with pomalidomide (POM) plus low-dose dexamethasone (POM + LoDEX) versus high-dose dexamethasone (HiDEX) in patients with RRMM in whom lenalidomide (LEN) and bortezomib (BORT) had failed. MM-003 also investigated HRQoL as a predefined secondary end point.PATIENTS AND METHODS: Recruited patients (n = 455) were refractory to their last treatment and had failed LEN and BORT after ≥ 2 consecutive cycles of each (alone or in combination). Eight clinically relevant and validated HRQoL domains from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-MY20, and EQ-5D questionnaires were selected for analysis. Time to symptom worsening based on minimally important differences (MIDs) was calculated.RESULTS: Clinically meaningful improvements in HRQoL as determined by MIDs, regression analyses, and best response analyses were observed more frequently in patients receiving POM + LoDEX than in those receiving HiDEX. POM + LoDEX significantly extended median time to clinically meaningful worsening in HRQoL versus HiDEX in 4 HRQoL domains and demonstrated a trend in an additional 3 domains. Patients in the HiDEX arm experienced earlier HRQoL deterioration compared with those in the POM + LoDEX arm in each domain analyzed.CONCLUSION: POM + LoDEX offer good clinical outcomes that lead to improved and prolonged HRQoL compared with HiDEX in patients with RRMM and end-stage disease.

AB - BACKGROUND: Health-related quality of life (HRQoL) is an important element for consideration in treatment decisions in patients with relapsed/refractory multiple myeloma (RRMM). The pivotal MM-003 (A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone vs. High-Dose Dexamethasone in Patients With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study [NIMBUS]) randomized, open-label, multicenter, phase III trial demonstrated improved progression-free survival (PFS) and prolonged overall survival (OS) with pomalidomide (POM) plus low-dose dexamethasone (POM + LoDEX) versus high-dose dexamethasone (HiDEX) in patients with RRMM in whom lenalidomide (LEN) and bortezomib (BORT) had failed. MM-003 also investigated HRQoL as a predefined secondary end point.PATIENTS AND METHODS: Recruited patients (n = 455) were refractory to their last treatment and had failed LEN and BORT after ≥ 2 consecutive cycles of each (alone or in combination). Eight clinically relevant and validated HRQoL domains from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-MY20, and EQ-5D questionnaires were selected for analysis. Time to symptom worsening based on minimally important differences (MIDs) was calculated.RESULTS: Clinically meaningful improvements in HRQoL as determined by MIDs, regression analyses, and best response analyses were observed more frequently in patients receiving POM + LoDEX than in those receiving HiDEX. POM + LoDEX significantly extended median time to clinically meaningful worsening in HRQoL versus HiDEX in 4 HRQoL domains and demonstrated a trend in an additional 3 domains. Patients in the HiDEX arm experienced earlier HRQoL deterioration compared with those in the POM + LoDEX arm in each domain analyzed.CONCLUSION: POM + LoDEX offer good clinical outcomes that lead to improved and prolonged HRQoL compared with HiDEX in patients with RRMM and end-stage disease.

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Bortezomib

KW - Dexamethasone

KW - Disease Progression

KW - Disease-Free Survival

KW - Drug Resistance, Neoplasm

KW - Female

KW - Humans

KW - Lenalidomide

KW - Male

KW - Multiple Myeloma

KW - Neoplasm Recurrence, Local

KW - Quality of Life

KW - Thalidomide

KW - Clinical Trial, Phase III

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.clml.2015.05.007

DO - 10.1016/j.clml.2015.05.007

M3 - SCORING: Journal article

C2 - 26149712

VL - 15

SP - 519

EP - 530

JO - CL LYMPH MYELOM LEUK

JF - CL LYMPH MYELOM LEUK

SN - 2152-2650

IS - 9

ER -