{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T21:00:04Z","timestamp":1793826004766,"version":"4.6.1"},"reference-count":27,"publisher":"American Society of Hematology","issue":"9","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,8,27]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>In the primary analysis of ANDROMEDA, addition of subcutaneous daratumumab to VCd (bortezomib, cyclophosphamide, and dexamethasone; D-VCd) significantly improved hematologic complete response (CR) rate vs VCd, establishing D-VCd as the only approved therapy for light-chain (AL) amyloidosis. We present results from the preplanned final analysis. In this phase 3 trial, we randomly assigned 388 patients with newly diagnosed AL amyloidosis to 6 cycles of VCd alone (control group) or with subcutaneous daratumumab (D-VCd) followed by single-agent daratumumab every 4 weeks for up to 24 total cycles. The primary end point was hematologic CR. The updated hematologic CR rate was 59.5% for D-VCd vs 19.2% for VCd (odds ratio, 6.03; 95% confidence interval [CI], 3.80-9.58; P&amp;lt; .0001). Median time to hematologic CR was shorter with D-VCd (67.5 days [range, 8.0-879.0]) vs VCd (85.0 days [range, 14.0-617.0]). With a median follow-up of 61.4 months, significant improvement was observed with D-VCd vs VCd in major organ deterioration\u2013progression-free survival (hazard ratio, 0.44; 95% CI, 0.31-0.63; P&amp;lt; .0001) and overall survival (hazard ratio, 0.62; 95% CI, 0.42-0.90; P = .0121). Cardiac and renal response rates were 2 to 3 times higher with D-VCd vs VCd. Achieving hematologic or cardiac CR was associated with improved major organ deterioration\u2013progression-free survival and overall survival. Adverse events were consistent with the known safety profiles for VCd and daratumumab. Adding daratumumab to VCd resulted in deeper and more rapid hematologic responses and organ function recovery, translating to statistically significant improvement in both overall survival and major organ deterioration\u2013progression-free survival in newly diagnosed AL amyloidosis. This trial was registered at www.clinicaltrials.gov as #NCT03201965.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2025032099","type":"journal-article","created":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T17:02:29Z","timestamp":1778605349000},"page":"1097-1107","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":6,"title":["Daratumumab-bortezomib-cyclophosphamide-dexamethasone for newly diagnosed amyloidosis: ANDROMEDA final survival analysis"],"prefix":"10.1182","volume":"148","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8191-5832","authenticated-orcid":false,"given":"Efstathios","family":"Kastritis","sequence":"first","affiliation":[{"name":"1Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5994-5138","authenticated-orcid":false,"given":"Giovanni","family":"Palladini","sequence":"additional","affiliation":[{"name":"2Department of Molecular Medicine, University of Pavia, Pavia, Italy"},{"name":"3Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico San Matteo, Pavia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3139-8379","authenticated-orcid":false,"given":"Monique C.","family":"Minnema","sequence":"additional","affiliation":[{"name":"4Department of Hematology, University Medical Center Utrecht, University Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashutosh D.","family":"Wechalekar","sequence":"additional","affiliation":[{"name":"5University College London Hospital and National Amyloidosis Centre, University College London Royal Free Campus, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7091-8253","authenticated-orcid":false,"given":"Arnaud","family":"Jaccard","sequence":"additional","affiliation":[{"name":"6Reference Center for Amyloid Light-chain Amyloidosis, Limoges, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8545-3292","authenticated-orcid":false,"given":"Hans C.","family":"Lee","sequence":"additional","affiliation":[{"name":"7Department of Lymphoma and Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6307-2445","authenticated-orcid":false,"given":"Vaishali","family":"Sanchorawala","sequence":"additional","affiliation":[{"name":"8Amyloidosis Center, Boston University School of Medicine and Boston Medical Center, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Mollee","sequence":"additional","affiliation":[{"name":"9Department of Haematology, Princess Alexandra Hospital and University of Queensland Medical School, Brisbane, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin","family":"Lu","sequence":"additional","affiliation":[{"name":"10Peking University People\u2019s Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Sch\u00f6nland","sequence":"additional","affiliation":[{"name":"11Universit\u00e4tsklinikum Heidelberg Medizinische Klinik V, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9426-4482","authenticated-orcid":false,"given":"Moshe E.","family":"Gatt","sequence":"additional","affiliation":[{"name":"12Hadassah Medical Center, Jerusalem, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7132-5337","authenticated-orcid":false,"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"13Japanese Red Cross Medical Center, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kihyun","family":"Kim","sequence":"additional","affiliation":[{"name":"14Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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