{"entity":{"id":"paper-maia-daratumumab-rd-nejm-2019","kind":"paper","name":"MAIA: adding daratumumab to lenalidomide-dexamethasone for older patients with newly diagnosed myeloma who cannot have a transplant","aka":[],"tldr":"Adding the CD38 antibody daratumumab to standard lenalidomide-dexamethasone cut the risk of progression or death by about 44% in older myeloma patients, and later extended survival.","summary":"MAIA randomised 737 transplant-ineligible patients with newly diagnosed multiple myeloma (median age 73) to daratumumab plus lenalidomide and dexamethasone (D-Rd) or Rd alone, both continued until progression. The primary endpoint was PFS. At 30 months PFS was 70.6% versus 55.6% (hazard ratio 0.56); complete response or better was 47.6% versus 24.9% and MRD-negativity 24.2% versus 7.3%. Longer follow-up showed a significant overall survival benefit (hazard ratio about 0.68; five-year OS roughly 66% versus 53%). Neutropenia and pneumonia were more frequent with daratumumab.","asOf":"2026-09-08","links":[{"label":"Full text (DOI)","url":"https://doi.org/10.1056/NEJMoa1817249"},{"label":"ClinicalTrials.gov NCT02252172","url":"https://clinicaltrials.gov/study/NCT02252172"}],"tags":[],"related":["paper-cepheus-dara-vrd-natmed-2025","cd38-plus-triplet"],"cancers":["multiple-myeloma"],"sections":[],"technologies":[],"targets":["cd38"],"drugs":["daratumumab","lenalidomide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["pfs","os","mrd-negativity-myeloma"],"trials":[],"people":[],"bottlenecks":["b-aging-comorbidity","b-drug-pricing"],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2019,"doi":"10.1056/NEJMoa1817249","authors":"Facon T, Kumar S, Plesner T, et al.","paperType":"rct","findings":["737 transplant-ineligible patients; D-Rd vs Rd until progression.","30-month PFS 70.6% vs 55.6%; hazard ratio 0.56.","Complete response or better 47.6% vs 24.9%; MRD-negativity (10^-5) 24.2% vs 7.3%.","Overall survival significantly improved at longer follow-up (HR about 0.68; 5-year OS roughly 66% vs 53%).","Grade 3-4 neutropenia 50.0% vs 35.3%; pneumonia 13.7% vs 7.9%."],"whatItMeans":"MAIA made a daratumumab-based triplet the standard first treatment for older or frail myeloma patients, replacing Rd alone. It proved an anti-CD38 antibody could improve survival, not just delay progression, when used up front. Quadruplets built on this backbone are now being tested in the same population.","caveats":["Continuous therapy until progression; treatment burden and cost are substantial.","Patients over 80 and very frail patients were under-represented.","Median PFS was not reached at the primary analysis; the durability estimate relies on later reports.","Comparator Rd is itself now being displaced by quadruplets."],"changedPractice":true,"participants":737},"route":"/key-papers/paper-maia-daratumumab-rd-nejm-2019/","neighbours":{"paper":[{"id":"paper-cepheus-dara-vrd-natmed-2025","kind":"paper","name":"CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint","route":"/key-papers/paper-cepheus-dara-vrd-natmed-2025/"}],"pairing":[{"id":"cd38-plus-triplet","kind":"pairing","name":"CD38 antibody added to PI-IMiD-dex (quadruplet induction)","route":"/pairings/cd38-plus-triplet/"}],"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-transplant-ineligible","kind":"cancer","name":"Newly diagnosed multiple myeloma, transplant-ineligible","route":"/cancers/myeloma-transplant-ineligible/"}],"target":[{"id":"cd38","kind":"target","name":"CD38","route":"/targets/cd38/"}],"drug":[{"id":"daratumumab","kind":"drug","name":"Daratumumab","route":"/drugs/daratumumab/"},{"id":"lenalidomide","kind":"drug","name":"Lenalidomide","route":"/drugs/lenalidomide/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"term":[{"id":"mrd-negativity-myeloma","kind":"term","name":"MRD negativity (myeloma, 10⁻⁵ / 10⁻⁶)","route":"/terms/mrd-negativity-myeloma/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"pfs","kind":"term","name":"Progression-free survival (PFS)","route":"/terms/pfs/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}],"person":[{"id":"thierry-facon","kind":"person","name":"Thierry Facon","route":"/people/thierry-facon/"}],"trial":[{"id":"maia","kind":"trial","name":"MAIA","route":"/trials/maia/"}]}}