{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T05:36:40Z","timestamp":1773725800907,"version":"3.50.1"},"reference-count":32,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T00:00:00Z","timestamp":1727308800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Janssen-Cilag, S.A."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Real-world evidence on the impact of monoclonal antibodies as first-line treatment in Spain is limited. This observational, retrospective and prospective, multicenter, descriptive study included 117 transplant-ineligible newly diagnosed multiple myeloma (TIE-NDMM) patients divided into Group A, who received no daratumumab standard regimens, and the DVMP group (daratumumab, bortezomib, melphalan, and prednisone treatment). More than 90% of the patients in Group A received bortezomib, lenalidomide, or a combination of them. The median follow-up time for Group A was 38.2 months in comparison to 25.8 months for the DVMP group (p &lt; 0.0001). The rate of DVMP patients that experienced disease progression or death from any cause was 36.8%, compared to 67.3% of Group A patients at 36 months of follow-up. The DVMP group had a higher 36-month progression-free survival (PFS) rate (52.9% vs. 31.7%). During the retrospective period, 73.0% of patients reported adverse drug reactions, while in the prospective period, 40.5% experienced adverse events, with no clinical differences between groups. The study supports the use of daratumumab regimens in frontline therapy based on real-world data. The findings provide valuable insights into the clinical outcomes of daratumumab therapy, which can help physicians make informed decisions regarding the optimal treatment approach for this patient population.<\/jats:p>","DOI":"10.3390\/ph17101272","type":"journal-article","created":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T06:55:52Z","timestamp":1727333752000},"page":"1272","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Unravelling Transplant-Ineligible Newly Diagnosed Multiple Myeloma Treatment in Real-World Practice in Spain: The CARINAE Study"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4451-1318","authenticated-orcid":false,"given":"Felipe","family":"de Arriba de la Fuente","sequence":"first","affiliation":[{"name":"Hematology Department, Hospital Universitario Morales Meseguer, IMIB-Pascual Parrilla, Universidad de Murcia, 30008 Murcia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8106-8909","authenticated-orcid":false,"given":"Mercedes","family":"Gironella Mesa","sequence":"additional","affiliation":[{"name":"Hematology Department, Hospital Universitario Vall d\u2019Hebr\u00f3n, 08035 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miguel Teodoro","family":"Hern\u00e1ndez Garc\u00eda","sequence":"additional","affiliation":[{"name":"Hematology Department, Hospital Universitario de Canarias, 38320 La Laguna, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Alonso","family":"Soler Campos","sequence":"additional","affiliation":[{"name":"Hematology Department, Hosptial Universitario Parc Taul\u00ed, 08208 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susana","family":"Herr\u00e1ez Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"Hematology Department, Hospital Universitario Basurto, 48013 Bilbo, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda Jos\u00e9","family":"Moreno Belmonte","sequence":"additional","affiliation":[{"name":"Hematology Department, Hospital Universitario Virgen de la Arrixaca, 30120 Murcia, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Regueiro L\u00f3pez","sequence":"additional","affiliation":[{"name":"Spanish Multiple Myeloma Patient Community (CEMMP), 24560 Le\u00f3n, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4020-5038","authenticated-orcid":false,"given":"Miriam","family":"Gonz\u00e1lez-Pardo","sequence":"additional","affiliation":[{"name":"Medical Department, Janssen-Cilag S.A., Johnson & Johnson Company, 28042 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda","family":"Casanova Espinosa","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Clinical Oncology, Hospital Costa del Sol, 29603 Marbella, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the CARINAE Study Investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"719","DOI":"10.1002\/ajh.24402","article-title":"Multiple myeloma: 2016 update on diagnosis, risk-stratification, and management","volume":"91","author":"Rajkumar","year":"2016","journal-title":"Am. J. Hematol."},{"key":"ref_2","first-page":"315","article-title":"Healthcare reality of the treatment of the high-risk multiple myeloma in Spain","volume":"154","author":"Mesa","year":"2020","journal-title":"Med. Clin."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1200\/JCO.2013.48.7934","article-title":"International Myeloma Working Group Consensus Statement for the Management, Treatment, and Supportive Care of Patients with Myeloma Not Eligible for Standard Autologous Stem-Cell Transplantation","volume":"32","author":"Palumbo","year":"2014","journal-title":"J. Clin. Oncol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/S0140-6736(19)31240-1","article-title":"Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): A randomised, open-label, phase 3 study","volume":"394","author":"Moreau","year":"2019","journal-title":"Lancet"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1086","DOI":"10.1002\/ajh.26590","article-title":"Multiple myeloma: 2022 update on diagnosis, risk stratification, and management","volume":"97","author":"Rajkumar","year":"2022","journal-title":"Am. J. Hematol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"3406","DOI":"10.1200\/JCO.21.02614","article-title":"Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project","volume":"40","author":"Cairns","year":"2022","journal-title":"J. Clin. Oncol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1158\/2643-3230.BCD-21-0205","article-title":"Perspectives on the Risk-Stratified Treatment of Multiple Myeloma","volume":"3","author":"Davies","year":"2022","journal-title":"Blood Cancer Discov."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"368","DOI":"10.14236\/jhi.v22i3.177","article-title":"Creating and using real-world evidence to answer questions about clinical effectiveness","volume":"22","author":"Crawford","year":"2015","journal-title":"J. Innov. Health Inform."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1038\/s41408-021-00432-4","article-title":"Management of patients with multiple myeloma beyond the clinical-trial setting: Understanding the balance between efficacy, safety and tolerability, and quality of life","volume":"11","author":"Terpos","year":"2021","journal-title":"Blood Cancer J."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1038\/s41408-018-0141-0","article-title":"Interpreting clinical trial data in multiple myeloma: Translating findings to the real-world setting","volume":"8","author":"Richardson","year":"2018","journal-title":"Blood Cancer J."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1186\/s13045-016-0283-0","article-title":"Daratumumab: A first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma","volume":"9","author":"Sanchez","year":"2016","journal-title":"J. Hematol. Oncol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1358\/dot.2016.52.10.2543308","article-title":"Daratumumab: Monoclonal antibody therapy to treat multiple myeloma","volume":"52","author":"Xia","year":"2016","journal-title":"Drugs Today"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1182\/blood-2015-12-687749","article-title":"Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma","volume":"128","author":"Krejcik","year":"2016","journal-title":"Blood"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1002\/cyto.a.23693","article-title":"High-Parameter Mass Cytometry Evaluation of Relapsed\/Refractory Multiple Myeloma Patients Treated with Daratumumab Demonstrates Immune Modulation as a Novel Mechanism of Action","volume":"95","author":"Adams","year":"2019","journal-title":"Cytom. Part A"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"518","DOI":"10.1056\/NEJMoa1714678","article-title":"Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma","volume":"378","author":"Mateos","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1016\/S0140-6736(19)32956-3","article-title":"Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): A randomised, open-label, phase 3 trial","volume":"395","author":"Mateos","year":"2020","journal-title":"Lancet"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"2104","DOI":"10.1056\/NEJMoa1817249","article-title":"Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma","volume":"380","author":"Facon","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1182\/blood-2020-136145","article-title":"Long-Term Outcomes and Health-Related Quality of Life (HRQoL) By Response Status for Bortezomib, Melphalan, and Prednisone (VMP) \u00b1 Daratumumab (DARA) in Alcyone","volume":"136","author":"Boccadoro","year":"2020","journal-title":"Blood"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1200\/JCO.20.01370","article-title":"Health-Related Quality of Life in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma: Findings from the Phase III MAIA Trial","volume":"39","author":"Perrot","year":"2021","journal-title":"J. Clin. Oncol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.1182\/blood-2012-02-408922","article-title":"Superiority of bortezomib, thalidomide, and dexamethasone (VTD) as induction pretransplantation therapy in multiple myeloma: A randomized phase 3 PETHEMA\/GEM study","volume":"120","author":"Oriol","year":"2012","journal-title":"Blood"},{"key":"ref_21","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":"New Engl. J. Med."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1016\/j.annonc.2020.11.014","article-title":"Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up","volume":"32","author":"Dimopoulos","year":"2021","journal-title":"Ann. Oncol."},{"key":"ref_23","unstructured":"Janssen [Data on File]. Number of patients treated with DARZALEX worldwide as of 31 March 2024. RF-412474."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"476","DOI":"10.1182\/blood.V118.21.476.476","article-title":"Continued Overall Survival Benefit After 5 Years\u2019 Follow-up with Bortezomib-Melphalan-Prednisone (VMP) Versus Melphalan-Prednisone (MP) in Patients with Previously Untreated Multiple Myeloma, and No Increased Risk of Second Primary Malignancies: Final Results of the Phase 3 VISTA Trial","volume":"118","author":"Miguel","year":"2011","journal-title":"Blood"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"2259","DOI":"10.1200\/JCO.2009.26.0638","article-title":"Bortezomib Plus Melphalan and Prednisone Compared with Melphalan and Prednisone in Previously Untreated Multiple Myeloma: Updated Follow-Up and Impact of Subsequent Therapy in the Phase III VISTA Trial","volume":"28","author":"Mateos","year":"2010","journal-title":"J. Clin. Oncol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"906","DOI":"10.1056\/NEJMoa1402551","article-title":"Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Myeloma","volume":"371","author":"Benboubker","year":"2014","journal-title":"N. Engl. J. Med."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"2900","DOI":"10.1200\/JCO.2016.69.2517","article-title":"Depth of Response in Multiple Myeloma: A Pooled Analysis of Three PETHEMA\/GEM Clinical Trials","volume":"35","author":"Lahuerta","year":"2017","journal-title":"J. Clin. Oncol."},{"key":"ref_28","unstructured":"SEHH (2024, May 31). Gu\u00eda de Mieloma M\u00faltiple Grupo Espa\u00f1ol de Mieloma. Available online: https:\/\/www.sehh.es\/publicaciones\/guias-recomendaciones\/123889-guiasrecomendaciones-2020-2019."},{"key":"ref_29","unstructured":"Cedena, M., Puig, N., Paiva, B., P\u00e9rez, A., De Arriba, F., Cu\u00e9llar, C., Blanchard, M.J., Mart\u00ednez-Chamorro, C., Casanova, M., and Sirvent, M. (2019, January 24\u201326). Enfermedad m\u00ednima residual en la pr\u00e1ctica cl\u00ednica de pacientes con mieloma m\u00faltiple, C0-013. Proceedings of the LXI Congreso nacional de la sociedad Espa\u00f1ola de hematolog\u00eda y hemoterapia, Valencia, Espa\u00f1a."},{"key":"ref_30","unstructured":"Janssen [Data on File]. Cavex program Spain_ Affidavit. As of 7 May 2024. RF-418728."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Huynh, L., Birsen, R., Mora, L., Couderc, A.L., Mitha, N., Farcet, A., Chebib, A., and Chaibi, P. (2022). Multiple Myeloma in Patients over 80: A Real World Retrospective Study of First Line Conservative Approach with Bortezomib Dexamethasone Doublet Therapy and Mini-Review of Literature. Cancers, 14.","DOI":"10.3390\/cancers14194741"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"613","DOI":"10.1007\/s40271-021-00501-7","article-title":"Patient Perceptions Regarding Multiple Myeloma and Its Treatment: Qualitative Evidence from Interviews with Patients in the United Kingdom, France, and Germany","volume":"14","author":"He","year":"2021","journal-title":"Patient Patient Centered Outcomes Res."}],"container-title":["Pharmaceuticals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8247\/17\/10\/1272\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T16:03:43Z","timestamp":1760112223000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8247\/17\/10\/1272"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,26]]},"references-count":32,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2024,10]]}},"alternative-id":["ph17101272"],"URL":"https:\/\/doi.org\/10.3390\/ph17101272","relation":{},"ISSN":["1424-8247"],"issn-type":[{"value":"1424-8247","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,26]]}}}