{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T17:58:27Z","timestamp":1774115907587,"version":"3.50.1"},"reference-count":49,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T00:00:00Z","timestamp":1762646400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Although myeloma represents a key success story in oncology, some drugs have failed to meet primary endpoints in randomized controlled trials (RCTs), despite promising early phase activity. This analysis aimed to understand factors that increase the likelihood of meeting primary endpoints in myeloma RCTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Myeloma RCTs published through October 2023 were identified using MEDLINE, PubMed, Embase, and the Cochrane Registry. Studies were classified as head-to-head (substituting 1 regimen for another) or add-on (adding 1 drug to existing regimen). Trials were considered successful if they achieved statistical significance for primary outcomes. Logistic regression identified predictors of meeting trial endpoints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 145 comparisons from 123 RCTs were included. Only 2 factors were independently associated with meeting primary endpoints in multivariate analysis. Higher median participant age was associated with lower odds of meeting the primary endpoint (odds ratio [OR] per 1-year increase = 0.90, 95% confidence interval\u2009[CI] =\u20090.83 to 0.98). Overall survival (OS) was the primary endpoint in 20 of 145 comparisons, of which 3 of 20 met their endpoint. Selecting OS as primary endpoint was associated with reduced likelihood of success compared with progression-free survival by 94% (OR = 0.06, 95% CI\u2009=\u20090.01 to 0.23). Head-to-head design was not associated with lower success rates than add-on design (OR = 0.59; 95% CI\u2009=\u20090.22 to 1.62).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Two key factors predicted higher likelihood of meeting endpoints: younger patient age and primary endpoints other than OS. Although head-to-head design is considered riskier, it was not associated with decreased success. This analysis aims to better inform clinicians, industry, and regulators in myeloma drug development.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jnci\/djaf326","type":"journal-article","created":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T20:36:40Z","timestamp":1762720600000},"page":"448-458","source":"Crossref","is-referenced-by-count":0,"title":["Optimizing oncology drug development: systematic review of 22 years of myeloma randomized controlled trials"],"prefix":"10.1093","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5775-2241","authenticated-orcid":false,"given":"Maria","family":"Mainou","sequence":"first","affiliation":[{"name":"Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki , Thessaloniki,","place":["Greece"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muatassem","family":"Alsadhan","sequence":"additional","affiliation":[{"name":"Division of Hematology, Huntsman Cancer Institute, University of Utah , Salt Lake City, UT,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kalliopi","family":"Tsapa","sequence":"additional","affiliation":[{"name":"Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki , Thessaloniki,","place":["Greece"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7201-4642","authenticated-orcid":false,"given":"Alissa","family":"Visram","sequence":"additional","affiliation":[{"name":"Division of Hematology, McMaster University , Hamilton, ON,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hira","family":"Mian","sequence":"additional","affiliation":[{"name":"Division of Hematology, McMaster University , Hamilton, ON,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rakesh","family":"Popat","sequence":"additional","affiliation":[{"name":"Division of Hematology, University College London , London,","place":["United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6226-1252","authenticated-orcid":false,"given":"Elias K","family":"Mai","sequence":"additional","affiliation":[{"name":"Heidelberg Myeloma Center, Internal Medicine V, Hematology, Oncology and Rheumatology, Heidelberg University Hospital and Medical Faculty Heidelberg , Heidelberg,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7336-3003","authenticated-orcid":false,"given":"Rajshekhar","family":"Chakraborty","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Columbia University Medical Center , New York City, NY,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samer","family":"Al Hadidi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, UT Southwestern Medical Center , Dallas, TX,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meera","family":"Mohan","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Medicine, Medical College of Wisconsin , Milwaukee, WI,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8129-0614","authenticated-orcid":false,"given":"Aniko","family":"Szabo","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Medicine, Medical College of Wisconsin , Milwaukee, WI,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5824-197X","authenticated-orcid":false,"given":"Oliver","family":"Van Oekelen","sequence":"additional","affiliation":[{"name":"Department of Medicine, Icahn School of Medicine at Mt Sinai , New York City, NY,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5977-907X","authenticated-orcid":false,"given":"Edward R Scheffer","family":"Cliff","sequence":"additional","affiliation":[{"name":"Program On Regulation, Therapeutics and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital , Boston, MA,","place":["United States"]},{"name":"Department of Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital , Melbourne,","place":["Australia"]},{"name":"Sir Peter MacCallum Department of Oncology, The University of Melbourne , Melbourne,","place":["Australia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6464-783X","authenticated-orcid":false,"given":"Ghulam Rehman","family":"Mohyuddin","sequence":"additional","affiliation":[{"name":"Division of Hematology, Huntsman Cancer Institute, University of Utah , Salt Lake City, UT,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,11,9]]},"reference":[{"key":"2026032113015340300_djaf326-B1","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1001\/jama.2022.0003","article-title":"Diagnosis and management of multiple myeloma: a review","volume":"327","author":"Cowan","year":"2022","journal-title":"JAMA"},{"key":"2026032113015340300_djaf326-B2","doi-asserted-by":"crossref","first-page":"1928","DOI":"10.1200\/JCO.19.02515","article-title":"Long-term follow-up results of lenalidomide, bortezomib, and dexamethasone induction 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