Characteristics and outcomes in patients with lenalidomide-refractory multiple myeloma treated with 1-3 prior lines of therapy: Analysis of individual patient-level data from daratumumab clinical trials
The introduction of proteasome inhibitors (PIs) and lenalidomide as treatment for newly diagnosed multiple myeloma (MM) has led to an increased population of lenalidomide-refractory patients. Limited data are available characterizing current treatments and outcomes in this difficult-to-treat populat...
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| Veröffentlicht in: | European journal of cancer (1990) 2025-01, Vol.215, p.115157, Article 115157 |
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| container_title | European journal of cancer (1990) |
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| creator | Yong, Kwee Einsele, Hermann Schecter, Jordan M. Roccia, Tito Deraedt, William Lendvai, Nikoletta Slaughter, Ana Lonardi, Carolina Connors, Kaitlyn Qi, Keqin Londhe, Anil Carson, Robin Kharat, Akshay Cost, Patricia Valluri, Satish Mendes, João Pacaud, Lida Patel, Nitin Florendo, Erika Dhakal, Binod |
| description | The introduction of proteasome inhibitors (PIs) and lenalidomide as treatment for newly diagnosed multiple myeloma (MM) has led to an increased population of lenalidomide-refractory patients. Limited data are available characterizing current treatments and outcomes in this difficult-to-treat population.
Individual patient-level data were analyzed from the treatment arms of multiple daratumumab studies, including APOLLO, CASTOR, CANDOR, EQUULEUS, ALCYONE, MAIA, GRIFFIN, POLLUX, and CASSIOPEIA. Included patients were PI exposed and lenalidomide refractory, received 1–3 prior lines of therapy (LOT), and had an Eastern Cooperative Oncology Group performance status |
| doi_str_mv | 10.1016/j.ejca.2024.115157 |
| format | Article |
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Individual patient-level data were analyzed from the treatment arms of multiple daratumumab studies, including APOLLO, CASTOR, CANDOR, EQUULEUS, ALCYONE, MAIA, GRIFFIN, POLLUX, and CASSIOPEIA. Included patients were PI exposed and lenalidomide refractory, received 1–3 prior lines of therapy (LOT), and had an Eastern Cooperative Oncology Group performance status < 2. Treatments and outcomes were analyzed by number of prior LOT in the lenalidomide-refractory population. Time to next treatment (TTNT), progression-free survival (PFS), and overall survival (OS) were estimated using the Kaplan-Meier method.
Out of 4764 patients, 915 patients (prior LOT, one [n = 114]; two [n = 462]; three [n = 339]) met inclusion criteria. Median follow-up was 29·7 months (range 28·0–31·7). The overall response rate was 55·4 %. Estimated median TTNT was 9·7 months, median PFS was 10·0 months, and median OS was 27·5 months. Response rates and PFS decreased as number of prior LOT increased. Prognostic factors for response, TTNT, PFS, and OS included International Staging System stage, baseline plasmacytoma status, baseline hemoglobin, anti-CD38–refractory status, and cytogenetic risk status.
Lenalidomide-refractory patients treated with 1–3 prior LOT have poor PFS and OS, which generally worsen with each additional LOT, highlighting the need for new and effective treatments for this population.
•Outcomes were analyzed in patients with lenalidomide-refractory multiple myeloma.•Data represent treatment arms and subsequent therapies from 9 trials (2014–2022).•Outcomes were suboptimal: 55 % response rate, 10-mo median PFS, and 28-mo median OS.•New, effective therapies are needed for this difficult-to-treat population.</description><identifier>ISSN: 0959-8049</identifier><identifier>ISSN: 1879-0852</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2024.115157</identifier><identifier>PMID: 39673835</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Daratumumab ; Drug Resistance, Neoplasm ; Female ; Humans ; Lenalidomide - therapeutic use ; Lenalidomide-refractory multiple myeloma ; Lines of therapy ; Male ; Middle Aged ; Multiple Myeloma - drug therapy ; Multiple Myeloma - mortality ; Multiple Myeloma - pathology ; Outcomes ; Progression-Free Survival ; Real-world evidence ; Standard of care ; Treatment Outcome ; Treatment patterns</subject><ispartof>European journal of cancer (1990), 2025-01, Vol.215, p.115157, Article 115157</ispartof><rights>2024</rights><rights>Copyright © 2024. Published by Elsevier Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c1881-f2ba571227cd44f2fdb771037832c36b2b3db5727f529a59ee09e1908e1b15d53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejca.2024.115157$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39673835$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yong, Kwee</creatorcontrib><creatorcontrib>Einsele, Hermann</creatorcontrib><creatorcontrib>Schecter, Jordan M.</creatorcontrib><creatorcontrib>Roccia, Tito</creatorcontrib><creatorcontrib>Deraedt, William</creatorcontrib><creatorcontrib>Lendvai, Nikoletta</creatorcontrib><creatorcontrib>Slaughter, Ana</creatorcontrib><creatorcontrib>Lonardi, Carolina</creatorcontrib><creatorcontrib>Connors, Kaitlyn</creatorcontrib><creatorcontrib>Qi, Keqin</creatorcontrib><creatorcontrib>Londhe, Anil</creatorcontrib><creatorcontrib>Carson, Robin</creatorcontrib><creatorcontrib>Kharat, Akshay</creatorcontrib><creatorcontrib>Cost, Patricia</creatorcontrib><creatorcontrib>Valluri, Satish</creatorcontrib><creatorcontrib>Mendes, João</creatorcontrib><creatorcontrib>Pacaud, Lida</creatorcontrib><creatorcontrib>Patel, Nitin</creatorcontrib><creatorcontrib>Florendo, Erika</creatorcontrib><creatorcontrib>Dhakal, Binod</creatorcontrib><title>Characteristics and outcomes in patients with lenalidomide-refractory multiple myeloma treated with 1-3 prior lines of therapy: Analysis of individual patient-level data from daratumumab clinical trials</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>The introduction of proteasome inhibitors (PIs) and lenalidomide as treatment for newly diagnosed multiple myeloma (MM) has led to an increased population of lenalidomide-refractory patients. Limited data are available characterizing current treatments and outcomes in this difficult-to-treat population.
Individual patient-level data were analyzed from the treatment arms of multiple daratumumab studies, including APOLLO, CASTOR, CANDOR, EQUULEUS, ALCYONE, MAIA, GRIFFIN, POLLUX, and CASSIOPEIA. Included patients were PI exposed and lenalidomide refractory, received 1–3 prior lines of therapy (LOT), and had an Eastern Cooperative Oncology Group performance status < 2. Treatments and outcomes were analyzed by number of prior LOT in the lenalidomide-refractory population. Time to next treatment (TTNT), progression-free survival (PFS), and overall survival (OS) were estimated using the Kaplan-Meier method.
Out of 4764 patients, 915 patients (prior LOT, one [n = 114]; two [n = 462]; three [n = 339]) met inclusion criteria. Median follow-up was 29·7 months (range 28·0–31·7). The overall response rate was 55·4 %. Estimated median TTNT was 9·7 months, median PFS was 10·0 months, and median OS was 27·5 months. Response rates and PFS decreased as number of prior LOT increased. Prognostic factors for response, TTNT, PFS, and OS included International Staging System stage, baseline plasmacytoma status, baseline hemoglobin, anti-CD38–refractory status, and cytogenetic risk status.
Lenalidomide-refractory patients treated with 1–3 prior LOT have poor PFS and OS, which generally worsen with each additional LOT, highlighting the need for new and effective treatments for this population.
•Outcomes were analyzed in patients with lenalidomide-refractory multiple myeloma.•Data represent treatment arms and subsequent therapies from 9 trials (2014–2022).•Outcomes were suboptimal: 55 % response rate, 10-mo median PFS, and 28-mo median OS.•New, effective therapies are needed for this difficult-to-treat population.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Daratumumab</subject><subject>Drug Resistance, Neoplasm</subject><subject>Female</subject><subject>Humans</subject><subject>Lenalidomide - therapeutic use</subject><subject>Lenalidomide-refractory multiple myeloma</subject><subject>Lines of therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multiple Myeloma - drug therapy</subject><subject>Multiple Myeloma - mortality</subject><subject>Multiple Myeloma - pathology</subject><subject>Outcomes</subject><subject>Progression-Free Survival</subject><subject>Real-world evidence</subject><subject>Standard of care</subject><subject>Treatment Outcome</subject><subject>Treatment patterns</subject><issn>0959-8049</issn><issn>1879-0852</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc2O1DAQhC0EYoeFF-CAfOSSwT9xnCAuqxF_0kpc4Gw5dkfjkR0H2xmUV-Sp8DC7HDm11ar6Wq5C6DUle0po9-60h5PRe0ZYu6dUUCGfoB3t5dCQXrCnaEcGMTQ9aYcb9CLnEyFE9i15jm740Enec7FDvw9HnbQpkFwuzmSsZ4vjWkwMkLGb8aKLg7lk_MuVI_Ywa-9sDM5Ck2C6WGPacFh9cYsHHDbwMWhcEugC9uqiDcdLcjFh7-aKjRMuR0h62d7juwrcsvu7dLN1Z2dX7R_PNh7O4LHVReMpxVBfSZc1rEGP2FSaM1VcktM-v0TPpjrg1cO8RT8-ffx--NLcf_v89XB33xja97SZ2KiFpIxJY9t2YpMdpaSEy54zw7uRjdyOQjI5CTZoMQCQAehAeqAjFVbwW_T2yl1S_LlCLiq4bMB7PUNcs-K07aTspOBVyq5Sk2LONS9VYwg6bYoSdelQndSlQ3XpUF07rKY3D_x1DGD_WR5Lq4IPVwHUX54dJJVNDcuAdQlMUTa6__H_AOhcslc</recordid><startdate>20250117</startdate><enddate>20250117</enddate><creator>Yong, Kwee</creator><creator>Einsele, Hermann</creator><creator>Schecter, Jordan M.</creator><creator>Roccia, Tito</creator><creator>Deraedt, William</creator><creator>Lendvai, Nikoletta</creator><creator>Slaughter, Ana</creator><creator>Lonardi, Carolina</creator><creator>Connors, Kaitlyn</creator><creator>Qi, Keqin</creator><creator>Londhe, Anil</creator><creator>Carson, Robin</creator><creator>Kharat, Akshay</creator><creator>Cost, Patricia</creator><creator>Valluri, Satish</creator><creator>Mendes, João</creator><creator>Pacaud, Lida</creator><creator>Patel, Nitin</creator><creator>Florendo, Erika</creator><creator>Dhakal, Binod</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20250117</creationdate><title>Characteristics and outcomes in patients with lenalidomide-refractory multiple myeloma treated with 1-3 prior lines of therapy: Analysis of individual patient-level data from daratumumab clinical trials</title><author>Yong, Kwee ; Einsele, Hermann ; Schecter, Jordan M. ; Roccia, Tito ; Deraedt, William ; Lendvai, Nikoletta ; Slaughter, Ana ; Lonardi, Carolina ; Connors, Kaitlyn ; Qi, Keqin ; Londhe, Anil ; Carson, Robin ; Kharat, Akshay ; Cost, Patricia ; Valluri, Satish ; Mendes, João ; Pacaud, Lida ; Patel, Nitin ; Florendo, Erika ; Dhakal, Binod</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1881-f2ba571227cd44f2fdb771037832c36b2b3db5727f529a59ee09e1908e1b15d53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Daratumumab</topic><topic>Drug Resistance, Neoplasm</topic><topic>Female</topic><topic>Humans</topic><topic>Lenalidomide - therapeutic use</topic><topic>Lenalidomide-refractory multiple myeloma</topic><topic>Lines of therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multiple Myeloma - drug therapy</topic><topic>Multiple Myeloma - mortality</topic><topic>Multiple Myeloma - pathology</topic><topic>Outcomes</topic><topic>Progression-Free Survival</topic><topic>Real-world evidence</topic><topic>Standard of care</topic><topic>Treatment Outcome</topic><topic>Treatment patterns</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yong, Kwee</creatorcontrib><creatorcontrib>Einsele, Hermann</creatorcontrib><creatorcontrib>Schecter, Jordan M.</creatorcontrib><creatorcontrib>Roccia, Tito</creatorcontrib><creatorcontrib>Deraedt, William</creatorcontrib><creatorcontrib>Lendvai, Nikoletta</creatorcontrib><creatorcontrib>Slaughter, Ana</creatorcontrib><creatorcontrib>Lonardi, Carolina</creatorcontrib><creatorcontrib>Connors, Kaitlyn</creatorcontrib><creatorcontrib>Qi, Keqin</creatorcontrib><creatorcontrib>Londhe, Anil</creatorcontrib><creatorcontrib>Carson, Robin</creatorcontrib><creatorcontrib>Kharat, Akshay</creatorcontrib><creatorcontrib>Cost, Patricia</creatorcontrib><creatorcontrib>Valluri, Satish</creatorcontrib><creatorcontrib>Mendes, João</creatorcontrib><creatorcontrib>Pacaud, Lida</creatorcontrib><creatorcontrib>Patel, Nitin</creatorcontrib><creatorcontrib>Florendo, Erika</creatorcontrib><creatorcontrib>Dhakal, Binod</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yong, Kwee</au><au>Einsele, Hermann</au><au>Schecter, Jordan M.</au><au>Roccia, Tito</au><au>Deraedt, William</au><au>Lendvai, Nikoletta</au><au>Slaughter, Ana</au><au>Lonardi, Carolina</au><au>Connors, Kaitlyn</au><au>Qi, Keqin</au><au>Londhe, Anil</au><au>Carson, Robin</au><au>Kharat, Akshay</au><au>Cost, Patricia</au><au>Valluri, Satish</au><au>Mendes, João</au><au>Pacaud, Lida</au><au>Patel, Nitin</au><au>Florendo, Erika</au><au>Dhakal, Binod</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Characteristics and outcomes in patients with lenalidomide-refractory multiple myeloma treated with 1-3 prior lines of therapy: Analysis of individual patient-level data from daratumumab clinical trials</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2025-01-17</date><risdate>2025</risdate><volume>215</volume><spage>115157</spage><pages>115157-</pages><artnum>115157</artnum><issn>0959-8049</issn><issn>1879-0852</issn><eissn>1879-0852</eissn><abstract>The introduction of proteasome inhibitors (PIs) and lenalidomide as treatment for newly diagnosed multiple myeloma (MM) has led to an increased population of lenalidomide-refractory patients. Limited data are available characterizing current treatments and outcomes in this difficult-to-treat population.
Individual patient-level data were analyzed from the treatment arms of multiple daratumumab studies, including APOLLO, CASTOR, CANDOR, EQUULEUS, ALCYONE, MAIA, GRIFFIN, POLLUX, and CASSIOPEIA. Included patients were PI exposed and lenalidomide refractory, received 1–3 prior lines of therapy (LOT), and had an Eastern Cooperative Oncology Group performance status < 2. Treatments and outcomes were analyzed by number of prior LOT in the lenalidomide-refractory population. Time to next treatment (TTNT), progression-free survival (PFS), and overall survival (OS) were estimated using the Kaplan-Meier method.
Out of 4764 patients, 915 patients (prior LOT, one [n = 114]; two [n = 462]; three [n = 339]) met inclusion criteria. Median follow-up was 29·7 months (range 28·0–31·7). The overall response rate was 55·4 %. Estimated median TTNT was 9·7 months, median PFS was 10·0 months, and median OS was 27·5 months. Response rates and PFS decreased as number of prior LOT increased. Prognostic factors for response, TTNT, PFS, and OS included International Staging System stage, baseline plasmacytoma status, baseline hemoglobin, anti-CD38–refractory status, and cytogenetic risk status.
Lenalidomide-refractory patients treated with 1–3 prior LOT have poor PFS and OS, which generally worsen with each additional LOT, highlighting the need for new and effective treatments for this population.
•Outcomes were analyzed in patients with lenalidomide-refractory multiple myeloma.•Data represent treatment arms and subsequent therapies from 9 trials (2014–2022).•Outcomes were suboptimal: 55 % response rate, 10-mo median PFS, and 28-mo median OS.•New, effective therapies are needed for this difficult-to-treat population.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>39673835</pmid><doi>10.1016/j.ejca.2024.115157</doi></addata></record> |
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| identifier | ISSN: 0959-8049 |
| ispartof | European journal of cancer (1990), 2025-01, Vol.215, p.115157, Article 115157 |
| issn | 0959-8049 1879-0852 1879-0852 |
| language | eng |
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| subjects | Adult Aged Aged, 80 and over Antibodies, Monoclonal - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Daratumumab Drug Resistance, Neoplasm Female Humans Lenalidomide - therapeutic use Lenalidomide-refractory multiple myeloma Lines of therapy Male Middle Aged Multiple Myeloma - drug therapy Multiple Myeloma - mortality Multiple Myeloma - pathology Outcomes Progression-Free Survival Real-world evidence Standard of care Treatment Outcome Treatment patterns |
| title | Characteristics and outcomes in patients with lenalidomide-refractory multiple myeloma treated with 1-3 prior lines of therapy: Analysis of individual patient-level data from daratumumab clinical trials |
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