{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T14:01:56Z","timestamp":1787580116003,"version":"build-2736575974"},"reference-count":38,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T00:00:00Z","timestamp":1698278400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Celgene\/BMS","award":["RV-MM-PI-280"],"award-info":[{"award-number":["RV-MM-PI-280"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Introduction: The LenaMain trial (NCT00891384) reported increased progression-free survival with 25 mg of lenalidomide maintenance compared to 5 mg. Here, we report the patient-reported outcomes. Materials and Methods: Scores obtained from the EORTC Quality of Life Questionnaire C30 were analyzed for longitudinal changes from baseline within the groups as well as cross-sectional scores. Results: Compliance rates were high, with 95.7% at baseline and 70% during maintenance. At study entry, scores were high for functioning and low for symptoms. During maintenance, the median global health status\/quality of life (GHS\/QoL) was constant, without significant differences over time (median GHS\/QoL: 68 at baseline and 58 for Len high and 68 for Len low at 2 years) and between treatment arms (mean change &lt; 2). Similarly, most functional scale domains were constant. Notably, diarrhea increased consistently for both treatment arms (baseline: \u22121.905 (range: \u22125.78\u20131.97); end of year 2: 16.071 (range: 5.72\u201326.42); p &lt; 0.05). The subgroup analysis showed that neither disease activity, duration of treatment, nor adverse events affected the health-related quality of life (HR-QoL) or utility. Conclusion: High baseline scores were maintained throughout the trial without significant differences between the Len dosages, which supports continuous treatment with a dose tailored to patients\u2019 HR-QoL.<\/jats:p>","DOI":"10.3390\/cancers15215157","type":"journal-article","created":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T07:22:15Z","timestamp":1698304935000},"page":"5157","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Health-Related Quality of Life in Multiple Myeloma Patients Treated with High- or Low-Dose Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation\u2014Results from the LenaMain Trial (NCT00891384)"],"prefix":"10.3390","volume":"15","author":[{"given":"Amelie","family":"Boquoi","sequence":"first","affiliation":[{"name":"Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf, 40225 Duesseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aristoteles","family":"Giagounidis","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Onkologie, H\u00e4matologie und Palliativmedizin, Marien Hospital D\u00fcsseldorf, Rochusstr. 2, 40479 D\u00fcsseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0961-0035","authenticated-orcid":false,"given":"Hartmut","family":"Goldschmidt","sequence":"additional","affiliation":[{"name":"National Center for Tumor Diseases Heidelberg (NCT), 69120 Heidelberg, Germany"},{"name":"Department of Internal Medicine V, University of Heidelberg, 69120 Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Heinsch","sequence":"additional","affiliation":[{"name":"Helios Klinikum Duisburg, 47166 Duisburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathias J.","family":"Rummel","sequence":"additional","affiliation":[{"name":"Medizinische Klinik IV, University Hospital, 35392 Giessen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolaus","family":"Kr\u00f6ger","sequence":"additional","affiliation":[{"name":"University Hospital Eppendorf, 20251 Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6226-1252","authenticated-orcid":false,"given":"Elias K.","family":"Mai","sequence":"additional","affiliation":[{"name":"Department of Medicine V, Hematology, Oncology and Rheumatology, University of Heidelberg, 69120 Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Strapatsas","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf, 40225 Duesseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3652-6595","authenticated-orcid":false,"given":"Rainer","family":"Haas","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf, 40225 Duesseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guido","family":"Kobbe","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf, 40225 Duesseldorf, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,10,26]]},"reference":[{"key":"ref_1","unstructured":"Engelhardt, M., Ihorst, G., Singh, M., Rieth, A., Saba, G., Pellan, M., and Lebioda, A. (2020). Real-World Evaluation of Health-Related Quality of Life in Patients with Multiple Myeloma from Germany. Clin. Lymphoma Myeloma Leuk., S2152\u2013S2650."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"e13","DOI":"10.1016\/j.clml.2018.08.019","article-title":"Health-Related Quality of Life of Patients with Multiple Myeloma Treated in Routine Clinical Practice in France","volume":"19","author":"Touboul","year":"2019","journal-title":"Clin. Lymphoma Myeloma Leuk."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1275","DOI":"10.1080\/10428194.2018.1523399","article-title":"Health related quality of life for multiple myeloma patients according to treatment strategy after autologous stem cell transplant: A cross-sectional study using EORTC, EQ-5D and MY-20 scales","volume":"60","author":"Tay","year":"2019","journal-title":"Leuk. Lymphoma"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1007\/s11136-019-02307-5","article-title":"Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed\/refractory multiple myeloma, based on German benefit assessment data","volume":"29","author":"Weisel","year":"2020","journal-title":"Qual. Life Res."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1038\/s41408-019-0181-0","article-title":"Health-related quality of life in the ENDEAVOR study: Carfilzomib-dexamethasone vs. bortezomib-dexamethasone in relapsed\/refractory multiple myeloma","volume":"22","author":"Ludwig","year":"2019","journal-title":"Blood Cancer J."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"3002","DOI":"10.1080\/10428194.2021.1941927","article-title":"Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma","volume":"62","author":"Siegel","year":"2021","journal-title":"Leuk. Lymphoma"},{"key":"ref_7","unstructured":"Delforge, M., Minuk, L., Eisenmann, J.C., Arnulf, B., Canepa, L., Fragasso, A., Leyvraz, S., Langer, C., Ezaydi, Y., and Vogl, D.T. (2021). Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: Results from the randomized phase III ALCYONE trial. BMC Cancer, 21."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1038\/s41408-020-0273-x","article-title":"Developments in continuous therapy and maintenance treatment approaches for patients with newly diagnosed multiple myeloma","volume":"10","author":"Dimopoulos","year":"2020","journal-title":"Blood Cancer J."},{"key":"ref_9","first-page":"e528","article-title":"Multiple Myeloma: EHA-ESMO Clinical Practice Guidelines for Diagnosis, Treatment and Follow-up","volume":"5","author":"Dimopoulos","year":"2021","journal-title":"Hemasphere"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1546","DOI":"10.1016\/j.bbmt.2018.03.027","article-title":"Health-Related Quality of Life after Autologous Stem Cell Transplantation for Multiple Myeloma","volume":"24","author":"Chakraborty","year":"2018","journal-title":"Biol. Blood Marrow Transplant."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1323","DOI":"10.1080\/10428194.2020.1719091","article-title":"Health-related quality of life results from the IFM 2009 trial: Treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma","volume":"61","author":"Roussel","year":"2020","journal-title":"Leuk. Lymphoma"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"895","DOI":"10.1056\/NEJMoa1402888","article-title":"Autologous transplantation and maintenance therapy in multiple myeloma","volume":"371","author":"Palumbo","year":"2014","journal-title":"N. Engl. J. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"3279","DOI":"10.1200\/JCO.2017.72.6679","article-title":"Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis","volume":"35","author":"McCarthy","year":"2017","journal-title":"J. Clin. Oncol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1650","DOI":"10.3324\/haematol.2019.222299","article-title":"Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression: A prospective, open-label, multicenter, randomized, phase 3 study","volume":"105","author":"Nielsen","year":"2020","journal-title":"Haematologica"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1959","DOI":"10.1038\/leu.2013.185","article-title":"Review of health-related quality of life data in multiple myeloma patients treated with novel agents","volume":"27","author":"Sonneveld","year":"2013","journal-title":"Leukemia"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1709","DOI":"10.1007\/s00277-020-04023-4","article-title":"The clinical management of lenalidomide-based therapy in patients with newly diagnosed multiple myeloma","volume":"99","author":"Merz","year":"2020","journal-title":"Ann. Hematol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"5879","DOI":"10.1158\/1078-0432.CCR-20-0841","article-title":"Efficacy and Tolerability of High- versus Low-dose Lenalidomide Maintenance Therapy of Multiple Myeloma after Autologous Blood Stem Cell Transplantation","volume":"26","author":"Fenk","year":"2020","journal-title":"Clin. Cancer Res."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"2425","DOI":"10.1007\/s00277-018-3446-y","article-title":"Impact of post-transplantation maintenance therapy on health-related quality of life in patients with multiple myeloma: Data from the Connect\u00ae MM Registry","volume":"97","author":"Abonour","year":"2018","journal-title":"Ann. Hematol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1111\/ejh.12882","article-title":"A systematic review of health-related quality of life in longitudinal studies of myeloma patients","volume":"99","author":"Nielsen","year":"2017","journal-title":"Eur. J. Haematol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1046\/j.0902-4441.2003.00195.x","article-title":"Interpretation of quality of life scores in multiple myeloma by comparison with a reference population and assessment of the clinical importance of score differences","volume":"72","author":"Gulbrandsen","year":"2004","journal-title":"Eur. J. Haematol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1721","DOI":"10.1182\/blood.V122.21.1721.1721","article-title":"Psychometric performance of the EORTC Quality-of-Life Core questionnaire (QLQ-C30) and QLQ-Multiple Myeloma (QLQ-MY20) in relapsed\/refractory multiple myeloma (RRMM)","volume":"122","author":"Leleu","year":"2013","journal-title":"Blood"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1186\/1477-7525-8-79","article-title":"Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma","volume":"8","author":"Kvam","year":"2010","journal-title":"Health Qual. Life Outcomes"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1713","DOI":"10.1016\/j.ejca.2012.02.059","article-title":"Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30","volume":"48","author":"Cocks","year":"2012","journal-title":"Eur. J. Cancer."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1200\/JCO.2010.28.0107","article-title":"Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30","volume":"29","author":"Cocks","year":"2011","journal-title":"J. Clin. Oncol."},{"key":"ref_25","unstructured":"Scott, N.W., Fayers, P.M., Aaronson, N.K., Bottomley, A., de Graeff, A., Groenvold, M., Gundy, C., Koller, M., Petersen, M.A., and Sprangers, M.A.G. (2018, January 20). EORTC QLQ-C30 Reference Values. Available online: http:\/\/www.eortc.org\/app\/uploads\/sites\/2\/2018\/02\/reference_values_manual2008.pdf."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1024","DOI":"10.1038\/bmt.2015.83","article-title":"Consolidation and maintenance therapy for multiple myeloma after autologous transplantation: Where do we stand?","volume":"50","author":"Mohty","year":"2015","journal-title":"Bone Marrow Transplant."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1111\/ejh.12961","article-title":"Post-transplant consolidation plus lenalidomide maintenance vs lenalidomide maintenance alone in multiple myeloma: A systematic review","volume":"99","author":"Louzada","year":"2017","journal-title":"Eur. J. Haematol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"e456","DOI":"10.1016\/S2352-3026(20)30099-5","article-title":"Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02\/HO95): A multicentre, randomised, open-label, phase 3 study","volume":"7","author":"Cavo","year":"2020","journal-title":"Lancet Haematol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"948","DOI":"10.1111\/bjh.15649","article-title":"Bortezomib consolidation post-ASCT as frontline therapy for multiple myeloma deepens disease response and MRD-negative rate whilst maintaining QOL and response to re-treatment at relapse","volume":"185","author":"Cohen","year":"2019","journal-title":"Br. J. Haematol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"3796","DOI":"10.1182\/blood-2021-146698","article-title":"Early Versus Late Discontinuation of Maintenance Therapy in Multiple Myeloma","volume":"138","author":"Nunnelee","year":"2021","journal-title":"Blood"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"2467","DOI":"10.1182\/blood-2014-06-583302","article-title":"Lenalidomide-induced diarrhea in patients with myeloma is caused by bile acid malabsorption that responds to treatment","volume":"124","author":"Pawlyn","year":"2014","journal-title":"Blood"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"671","DOI":"10.1016\/j.jpainsymman.2012.11.003","article-title":"Living with advanced but stable multiple myeloma: A study of the symptom burden and cumulative effects of disease and intensive (hematopoietic stem cell transplant-based) treatment on health-related quality of life","volume":"46","author":"Boland","year":"2013","journal-title":"J. Pain. Symptom Manag."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"934","DOI":"10.1182\/blood.V116.21.934.934","article-title":"Determinants of Global QOL and Physical and Social Functionality in Multiple Myeloma","volume":"116","author":"Jordan","year":"2010","journal-title":"Blood"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"2208","DOI":"10.1038\/leu.2016.147","article-title":"Early relapse following initial therapy for multiple myeloma predicts poor outcomes in the era of novel agents","volume":"30","author":"Majithia","year":"2016","journal-title":"Leukemia"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"816","DOI":"10.1111\/bjh.15459","article-title":"Quality of life during and following sequential treatment of previously untreated patients with multiple myeloma: Findings of the Medical Research Council Myeloma IX randomised study","volume":"182","author":"Royle","year":"2018","journal-title":"Br. J. Haematol."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1080\/10428194.2017.1334125","article-title":"Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone","volume":"59","author":"Vogl","year":"2018","journal-title":"Leuk. Lymphoma"},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1080\/17512433.2022.2032656","article-title":"The era of lenalidomide maintenance therapy in multiple myeloma: Settings for achieving best outcomes","volume":"15","author":"Kesireddy","year":"2022","journal-title":"Expert. Rev. Clin. Pharmacol."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1056\/NEJMoa2204925","article-title":"Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma","volume":"387","author":"Richardson","year":"2022","journal-title":"N. Engl. J. Med."}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/15\/21\/5157\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:12:17Z","timestamp":1760130737000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/15\/21\/5157"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,26]]},"references-count":38,"journal-issue":{"issue":"21","published-online":{"date-parts":[[2023,11]]}},"alternative-id":["cancers15215157"],"URL":"https:\/\/doi.org\/10.3390\/cancers15215157","relation":{},"ISSN":["2072-6694"],"issn-type":[{"value":"2072-6694","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,26]]}}}