Health-related quality of life in relapsed/refractory multiple
myeloma treated with melflufen and dexamethasone: analyses from
the phase III OCEAN study

J 2024

Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study

SCHJESVOLD, Fredrik H, Heinz LUDWIG, Sossana DELIMPASI, Pawel ROBAK, Daniel CORIU et. al.

Základní údaje

Originální název

Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study

Autoři

SCHJESVOLD, Fredrik H, Heinz LUDWIG, Sossana DELIMPASI, Pawel ROBAK, Daniel CORIU, Waldemar TOMCZAK, Luděk POUR (203 Česká republika, domácí), Ivan SPICKA, Meletios-Athanasios DIMOPOULOS, Tamas MASSZI, Natalia G CHERNOVA, Anna SANDBERG, Marcus THURESSON, Stefan NORIN, Nicolaas A BAKKER, Maria-Victoria MATEOS, Paul G RICHARDSON a Pieter SONNEVELD

Vydání

Haematologica, PAVIA, FERRATA STORTI FOUNDATION, 2024, 0390-6078

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Itálie

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 10.100 v roce 2022

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.3324/haematol.2023.284635

UT WoS

001263361100038

Klíčová slova anglicky

multiple myeloma; melflufen; dexamethasone

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 15. 8. 2024 10:09, Mgr. Tereza Miškechová

Anotace

V originále

Relapsed or refractory multiple myeloma (RRMM) is associated with severe symptoms, some of which have been strongly linked to impairments in health-related quality of life (HRQoL), notably pain, fatigue, and a decline in physical and emotional functioning. Furthermore, HRQoL deteriorates with each subsequent line of therapy in RRMM. Hence, treatment goals, particularly in later lines of therapy, should include preserving HRQoL. Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that utilizes increased peptidase expression to selectively release potent alkylating agents inside tumor cells. Melflufen is approved in Europe for the treatment of patients with triple-class refractory RRMM with ≥3 prior lines of therapy and time to progression (TTP) >36 months after prior autologous stem cell transplant (ASCT), if received. Approval was based on the results of the phase II HORIZON study and further supported by those of the phase III OCEAN study. OCEAN met its primary endpoint with melflufen plus dexamethasone demonstrating superior progression-free survival compared with pomalidomide plus dexamethasone in RRMM. Across trials, the safety profile of melflufen plus dexamethasone has been characterized primarily by hematologic adverse events that are clinically manageable, with infrequent grade 3/4 non-hematologic adverse events. HRQoL over time was preserved with melflufen plus dexamethasone in patients with advanced RRMM in the HORIZON trial..7 Pomalidomide plus dexamethasone has also been shown to be safe and effective without negatively affecting HRQoL, including in later lines of therapy.8 In this letter, we report HRQoL based on patient-reported outcomes (PRO) in a subset of patients from OCEAN receiving either melflufen plus dexamethasone or pomalidomide plus dexamethasone. Overall, melflufen plus dexamethasone treatment resulted in HRQoL comparable to that of pomalidomide plus dexamethasone, further supporting the use of melflufen plus dexamethasone in heavily pretreated patients with RRMM.

Citovat

SCHJESVOLD, Fredrik H, Heinz LUDWIG, Sossana DELIMPASI, Pawel ROBAK, Daniel CORIU, Waldemar TOMCZAK, Luděk POUR, Ivan SPICKA, Meletios-Athanasios DIMOPOULOS, Tamas MASSZI, Natalia G CHERNOVA, Anna SANDBERG, Marcus THURESSON, Stefan NORIN, Nicolaas A BAKKER, Maria-Victoria MATEOS, Paul G RICHARDSON a Pieter SONNEVELD. Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study. Haematologica. PAVIA: FERRATA STORTI FOUNDATION, 2024, roč. 109, č. 7, s. 2331-2336. ISSN 0390-6078. Dostupné z: https://dx.doi.org/10.3324/haematol.2023.284635.

@article{2423151,
   author = {Schjesvold, Fredrik H and Ludwig, Heinz and Delimpasi, Sossana and Robak, Pawel and Coriu, Daniel and Tomczak, Waldemar and Pour, Luděk and Spicka, Ivan and Dimopoulos, MeletiosandAthanasios and Masszi, Tamas and Chernova, Natalia G and Sandberg, Anna and Thuresson, Marcus and Norin, Stefan and Bakker, Nicolaas A and Mateos, MariaandVictoria and Richardson, Paul G and Sonneveld, Pieter},
   article_location = {PAVIA},
   article_number = {7},
   doi = {http://dx.doi.org/10.3324/haematol.2023.284635},
   keywords = {multiple myeloma; melflufen; dexamethasone},
   language = {eng},
   issn = {0390-6078},
   journal = {Haematologica},
   title = {Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study},
   url = {https://haematologica.org/article/view/haematol.2023.284635},
   volume = {109},
   year = {2024}
}

TY  - JOUR
ID  - 2423151
AU  - Schjesvold, Fredrik H - Ludwig, Heinz - Delimpasi, Sossana - Robak, Pawel - Coriu, Daniel - Tomczak, Waldemar - Pour, Luděk - Spicka, Ivan - Dimopoulos, Meletios-Athanasios - Masszi, Tamas - Chernova, Natalia G - Sandberg, Anna - Thuresson, Marcus - Norin, Stefan - Bakker, Nicolaas A - Mateos, Maria-Victoria - Richardson, Paul G - Sonneveld, Pieter
PY  - 2024
TI  - Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study
JF  - Haematologica
VL  - 109
IS  - 7
SP  - 2331-2336
EP  - 2331-2336
PB  - FERRATA STORTI FOUNDATION
SN  - 03906078
KW  - multiple myeloma
KW  - melflufen
KW  - dexamethasone
UR  - https://haematologica.org/article/view/haematol.2023.284635
N2  - Relapsed or refractory multiple myeloma (RRMM) is associated with severe symptoms, some of which have been strongly linked to impairments in health-related quality of life (HRQoL), notably pain, fatigue, and a decline in physical and emotional functioning. Furthermore, HRQoL deteriorates with each subsequent line of therapy in RRMM. Hence, treatment goals, particularly in later lines of therapy, should include preserving HRQoL. Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that utilizes increased peptidase expression to selectively release potent alkylating agents inside tumor cells. Melflufen is approved in Europe for the treatment of patients with triple-class refractory RRMM with ≥3 prior lines of therapy and time to progression (TTP) >36 months after prior autologous stem cell transplant (ASCT), if received. Approval was based on the results of the phase II HORIZON study and further supported by those of the phase III OCEAN study. OCEAN met its primary endpoint with melflufen plus dexamethasone demonstrating superior progression-free survival compared with pomalidomide plus dexamethasone in RRMM. Across trials, the safety profile of melflufen plus dexamethasone has been characterized primarily by hematologic adverse events that are clinically manageable, with infrequent grade 3/4 non-hematologic adverse events. HRQoL over time was preserved with melflufen plus dexamethasone in patients with advanced RRMM in the HORIZON trial..7 Pomalidomide plus dexamethasone has also been shown to be safe and effective without negatively affecting HRQoL, including in later lines of therapy.8 In this letter, we report HRQoL based on patient-reported outcomes (PRO) in a subset of patients from OCEAN receiving either melflufen plus dexamethasone or pomalidomide plus dexamethasone. Overall, melflufen plus dexamethasone treatment resulted in HRQoL comparable to that of pomalidomide plus dexamethasone, further supporting the use of melflufen plus dexamethasone in heavily pretreated patients with RRMM.
ER  -

SCHJESVOLD, Fredrik H, Heinz LUDWIG, Sossana DELIMPASI, Pawel ROBAK, Daniel CORIU, Waldemar TOMCZAK, Luděk POUR, Ivan SPICKA, Meletios-Athanasios DIMOPOULOS, Tamas MASSZI, Natalia G CHERNOVA, Anna SANDBERG, Marcus THURESSON, Stefan NORIN, Nicolaas A BAKKER, Maria-Victoria MATEOS, Paul G RICHARDSON a Pieter SONNEVELD. Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study. \textit{Haematologica}. PAVIA: FERRATA STORTI FOUNDATION, 2024, roč.~109, č.~7, s.~2331-2336. ISSN~0390-6078. Dostupné z: https://dx.doi.org/10.3324/haematol.2023.284635.

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