Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F24%3A10475680" target="_blank" >RIV/00179906:_____/24:10475680 - isvavai.cz</a>
Alternative codes found
RIV/00216224:14110/24:00136422 RIV/61988987:17110/24:A25039NF RIV/00216208:11110/24:10475680 RIV/00216208:11150/24:10475680 and 3 more
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=FqxxJcahQW" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=FqxxJcahQW</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.3324/haematol.2023.283509" target="_blank" >10.3324/haematol.2023.283509</a>
Alternative languages
Result language
angličtina
Original language name
Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study
Original language description
Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone was approved in Europe for use in patients with triple-class refractory relapsed/refractory multiple myeloma (RRMM) with >=3 prior lines of therapy and without prior autologous stem cell transplantation (ASCT) or with a time to progression >36 months after prior ASCT. The randomized LIGHTHOUSE study (NCT04649060) assessed melflufen plus daratumumab and dexamethasone (melflufen group) versus daratumumab in patients with RRMM with disease refractory to an immunomodulatory agent and a proteasome inhibitor or who had received >=3 prior lines of therapy including an immunomodulatory agent and a proteasome inhibitor. A partial clinical hold issued by the US Food and Drug Administration for all melflufen studies led to financial constraints and premature study closure on February 23, 2022 (data cutoff date). In total, 54 of 240 planned patients were randomized (melflufen group, n=27; daratumumab group, n=27). Median progression-free survival (PFS) was not reached in the melflufen group versus 4.9 months in the daratumumab group (hazard ratio, 0.18 [95% confidence interval, 0.05-0.65]; P=0.0032) at a median follow-up time of 7.1 and 6.6 months, respectively. Overall response rate (ORR) was 59% in the melflufen group versus 30% in the daratumumab group (P=0.0300). The most common grade >=3 treatment-emergent adverse events in the melflufen group versus daratumumab group were neutropenia (50% versus 12%), thrombocytopenia (50% versus 8%), and anemia (32% versus 19%). Melflufen plus daratumumab and dexamethasone demonstrated superior PFS and ORR versus daratumumab in RRMM and a safety profile comparable to previously published melflufen studies.
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30205 - Hematology
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Haematologica
ISSN
0390-6078
e-ISSN
1592-8721
Volume of the periodical
109
Issue of the periodical within the volume
3
Country of publishing house
IT - ITALY
Number of pages
11
Pages from-to
895-905
UT code for WoS article
001182209400032
EID of the result in the Scopus database
2-s2.0-85186504971