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

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 - Not freely accessible but may have access through institution

PY - 2015/6/5

Y1 - 2015/6/5

N2 - BackgroundHealth-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 - BackgroundHealth-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 - Low dose dexamethasone

KW - Multiple myeloma

KW - Pomalidomide

KW - Quality of life

KW - Relapsed/Refractory

UR - http://www.scopus.com/inward/record.url?scp=84936976646&partnerID=8YFLogxK

U2 - 10.1016/j.clml.2015.05.007

DO - 10.1016/j.clml.2015.05.007

M3 - Article

SN - 2152-2650

JO - Clinical Lymphoma Myeloma & Leukemia

JF - Clinical Lymphoma Myeloma & Leukemia

ER -