Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics

Paul G Richardson; Fredrik Schjesvold; Katja Weisel; Philippe Moreau; Larry D Anderson; Darrell White; Paula Rodriguez-Otero; Pieter Sonneveld; Monika Engelhardt; Matthew Jenner; Alessandro Corso; Jan Dürig; Michel Pavic; Morten Salomo; Meral Beksac; Albert Oriol; Jindriska Lindsay; Anna Marina Liberati; Monica Galli; Pawel Robak; Alessandra Larocca; Munci Yagci; Filiz Vural; Abraham S Kanate; Ruiyun Jiang; Lara Grote; Teresa Peluso; Meletios Dimopoulos

doi:10.1111/ejh.13706

Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics

Paul G Richardson^*, Fredrik Schjesvold, Katja Weisel, Philippe Moreau, Larry D Anderson, Darrell White, Paula Rodriguez-Otero, Pieter Sonneveld, Monika Engelhardt, Matthew Jenner, Alessandro Corso, Jan Dürig, Michel Pavic, Morten Salomo, Meral Beksac, Albert Oriol, Jindriska Lindsay, Anna Marina Liberati, Monica Galli, Pawel RobakAlessandra Larocca, Munci Yagci, Filiz Vural, Abraham S Kanate, Ruiyun Jiang, Lara Grote, Teresa Peluso, Meletios Dimopoulos

^*Corresponding author af dette arbejde

Afdeling for Blodsygdomme

11 Citationer (Scopus)

Abstract

OBJECTIVE: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse.

METHODS: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS).

RESULTS: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports.

CONCLUSIONS: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.

Originalsprog	Engelsk
Tidsskrift	European Journal of Haematology
Vol/bind	108
Udgave nummer	1
Sider (fra-til)	73-83
Antal sider	11
ISSN	0902-4441
DOI	https://doi.org/10.1111/ejh.13706
Status	Udgivet - jan. 2022

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10.1111/ejh.13706

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Richardson, P. G., Schjesvold, F., Weisel, K., Moreau, P., Anderson, L. D., White, D., Rodriguez-Otero, P., Sonneveld, P., Engelhardt, M., Jenner, M., Corso, A., Dürig, J., Pavic, M., Salomo, M., Beksac, M., Oriol, A., Lindsay, J., Liberati, A. M., Galli, M., ... Dimopoulos, M. (2022). Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics. European Journal of Haematology, 108(1), 73-83. https://doi.org/10.1111/ejh.13706

Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics. / Richardson, Paul G; Schjesvold, Fredrik; Weisel, Katja et al.
I: European Journal of Haematology, Bind 108, Nr. 1, 01.2022, s. 73-83.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Richardson, PG, Schjesvold, F, Weisel, K, Moreau, P, Anderson, LD, White, D, Rodriguez-Otero, P, Sonneveld, P, Engelhardt, M, Jenner, M, Corso, A, Dürig, J, Pavic, M, Salomo, M, Beksac, M, Oriol, A, Lindsay, J, Liberati, AM, Galli, M, Robak, P, Larocca, A, Yagci, M, Vural, F, Kanate, AS, Jiang, R, Grote, L, Peluso, T & Dimopoulos, M 2022, 'Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics', European Journal of Haematology, bind 108, nr. 1, s. 73-83. https://doi.org/10.1111/ejh.13706

@article{dd8444d3e6394297a08c89909261648c,

title = "Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics",

abstract = "OBJECTIVE: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse.METHODS: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS).RESULTS: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports.CONCLUSIONS: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.",

keywords = "Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Bortezomib/administration & dosage, Dexamethasone/administration & dosage, Drug Resistance, Neoplasm, Female, Humans, Lenalidomide/therapeutic use, Male, Middle Aged, Multiple Myeloma/drug therapy, Prognosis, Recurrence, Retreatment, Thalidomide/administration & dosage, Treatment Outcome",

author = "Richardson, {Paul G} and Fredrik Schjesvold and Katja Weisel and Philippe Moreau and Anderson, {Larry D} and Darrell White and Paula Rodriguez-Otero and Pieter Sonneveld and Monika Engelhardt and Matthew Jenner and Alessandro Corso and Jan D{\"u}rig and Michel Pavic and Morten Salomo and Meral Beksac and Albert Oriol and Jindriska Lindsay and Liberati, {Anna Marina} and Monica Galli and Pawel Robak and Alessandra Larocca and Munci Yagci and Filiz Vural and Kanate, {Abraham S} and Ruiyun Jiang and Lara Grote and Teresa Peluso and Meletios Dimopoulos",

note = "{\textcopyright} 2021 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.",

year = "2022",

month = jan,

doi = "10.1111/ejh.13706",

language = "English",

volume = "108",

pages = "73--83",

journal = "European Journal of Haematology",

issn = "0902-4441",

publisher = "Wiley-Blackwell Munksgaard",

number = "1",

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TY - JOUR

T1 - Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma

T2 - A subanalysis of OPTIMISMM by clinical characteristics

AU - Richardson, Paul G

AU - Schjesvold, Fredrik

AU - Weisel, Katja

AU - Moreau, Philippe

AU - Anderson, Larry D

AU - White, Darrell

AU - Rodriguez-Otero, Paula

AU - Sonneveld, Pieter

AU - Engelhardt, Monika

AU - Jenner, Matthew

AU - Corso, Alessandro

AU - Dürig, Jan

AU - Pavic, Michel

AU - Salomo, Morten

AU - Beksac, Meral

AU - Oriol, Albert

AU - Lindsay, Jindriska

AU - Liberati, Anna Marina

AU - Galli, Monica

AU - Robak, Pawel

AU - Larocca, Alessandra

AU - Yagci, Munci

AU - Vural, Filiz

AU - Kanate, Abraham S

AU - Jiang, Ruiyun

AU - Grote, Lara

AU - Peluso, Teresa

AU - Dimopoulos, Meletios

PY - 2022/1

Y1 - 2022/1

N2 - OBJECTIVE: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse.METHODS: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS).RESULTS: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports.CONCLUSIONS: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.

AB - OBJECTIVE: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse.METHODS: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS).RESULTS: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports.CONCLUSIONS: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects

KW - Bortezomib/administration & dosage

KW - Dexamethasone/administration & dosage

KW - Drug Resistance, Neoplasm

KW - Female

KW - Humans

KW - Lenalidomide/therapeutic use

KW - Male

KW - Middle Aged

KW - Multiple Myeloma/drug therapy

KW - Prognosis

KW - Recurrence

KW - Retreatment

KW - Thalidomide/administration & dosage

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85115264782&partnerID=8YFLogxK

U2 - 10.1111/ejh.13706

DO - 10.1111/ejh.13706

M3 - Journal article

C2 - 34496096

SN - 0902-4441

VL - 108

SP - 73

EP - 83

JO - European Journal of Haematology

JF - European Journal of Haematology

IS - 1

ER -

Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics

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