{
  "abstract": "Background: The phase 3 CEPHEUS study established that daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) improved overall minimal residual disease (MRD)-negativity (neg) rates and progression-free survival (PFS) vs VRd in patients with transplant-ineligible (TIE) or transplant-deferred newly diagnosed multiple myeloma (NDMM). The first analysis of the DVRd TIE subpopulation at a median follow-up of 58.7 months (mo) showed a complete response or better (≥CR) rate of 80.6% and overall MRD neg rate of 60.4%, with ∼70% of patients alive and progression free. Aims: This final analysis of the CEPHEUS TIE subpopulation describes a longer median follow-up of 76.0 mo. Methods: The primary endpoint of overall MRD neg rate (10-5 and ≥CR), and secondary endpoints, including investigator-assessed PFS and ≥CR rate, and sustained MRD neg (confirmed MRD neg ≥12 mo +/- 1 mo apart without MRD positivity in between and ≥CR) were assessed in the TIE population. The study was closed at the final analysis and patients were able to continue their study treatment via post-study access. Results: Of 395 patients enrolled, 289 patients with TIE NDMM received either DVRd (n=144) or VRd (n=145). The overall MRD neg rate at 10-5 was 61.1% for DVRd and 40.0% for VRd (odds ratio [OR] 2.35; 95% CI 1.47–3.77; P=0.0004) and at 10-6 was 46.5% for DVRd vs 27.6% for VRd (OR 2.27; 95% CI 1.39–3.71; P=0.0010). Sustained MRD neg rate at 10-5 was 49.3% for DVRd and 29.0% for VRd (OR 2.40; 95% CI 1.47–3.91; P=0.0005) and at 10-6 was 37.5% for DVRd and 16.6% for VRd (OR 3.01; 95% CI 1.73–5.24; P<0.0001). Overall ≥CR rate was 80.6% for DVRd and 61.4% for VRd (OR 2.64; 95% CI 1.54–4.51; P=0.0003). Median investigator-assessed PFS was not estimable (NE; 95% CI 74.81–NE) for DVRd and was 50.20 mo (95% CI 41.95–62.95) for VRd (hazard ratio [HR] 0.55; 95% CI 0.39–0.78; P=0.0007), with 59.3% for DVRd vs 38.3% for VRd alive and progression free at 72 mo. Overall survival favored DVRd over VRd (HR 0.84; 95% CI 0.57–1.24), particularly when censoring for COVID-19, which significantly impacted this study (HR 0.74; 95% CI 0.49–1.12). The treatment effect was consistent across most subgroups (Table). Conclusion: After median follow-up of over 6 years, the final analysis of the CEPHEUS trial demonstrated that TIE patients treated with DVRd continue to have deep and durable responses compared with those on VRd, which is crucial for patients for whom transplant is not an option. These data continue to reinforce DVRd as a standard of care in the TIE NDMM population.",
  "abstract_shown": true,
  "affiliations": [
    "Memorial Sloan Kettering Cancer Center, New York, United States",
    "University of Lille, CHU Lille, Service des Maladies du Sang, France",
    "Clínica Médica São Germano, São Paulo, SP, Brasil",
    "Arnie Charbonneau Cancer Research Institute, University of Calgary, Canada",
    "Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada; BC Cancer–Vancouver Centre, University of British Columbia, Canada",
    "Perlmutter Cancer Center, NYU Langone Health, United States",
    "University Hospital Brno, Czech Republic",
    "Hospital Universitario Mútua de Terrassa, Spain",
    "Royal Wolverhampton NHS Trust and University of Wolverhampton, CRN West Midlands, NIHR, United Kingdom",
    "Tel Aviv Sourasky (Ichilov) Medical Center, Tel Aviv, Israel; Gray Faculty of Medical and Health Sciences, Tel Aviv University, Israel",
    "Japanese Red Cross Medical Center, Tokio, Japan",
    "Hôpital Haut Lévêque, University Hospital, France",
    "School of Public Health, Medical University of Silesia, Poland",
    "Istinye University, Ankara Liv Hospital, Türkiye",
    "Instituto Americas de Ensino, Pesquisa e Inovação, Rio de Janeiro, RJ, Brazil; Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil",
    "Johnson & Johnson Raritan, NJ, United States",
    "Johnson & Johnson Leiden, The Netherlands",
    "Johnson & Johnson High Wycombe, United Kingdom",
    "Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Netherlands"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 20,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Saad Z USMANI"
    },
    {
      "affs": [
        1
      ],
      "name": "Thierry FACON"
    },
    {
      "affs": [
        2
      ],
      "name": "Vania HUNGRIA"
    },
    {
      "affs": [
        3
      ],
      "name": "Nizar J BAHLIS"
    },
    {
      "affs": [
        4
      ],
      "name": "Christopher P VENNER"
    },
    {
      "affs": [
        5
      ],
      "name": "Marc BRAUNSTEIN"
    },
    {
      "affs": [
        6
      ],
      "name": "Ludek POUR"
    },
    {
      "affs": [
        7
      ],
      "name": "Josep MARTI"
    },
    {
      "affs": [
        8
      ],
      "name": "Supratik BASU"
    },
    {
      "affs": [
        9
      ],
      "name": "Yael C COHEN"
    },
    {
      "affs": [
        10
      ],
      "name": "Kenshi SUZUKI"
    },
    {
      "affs": [
        11
      ],
      "name": "Cyrille HULIN"
    },
    {
      "affs": [
        12
      ],
      "name": "Sebastian GROSICKI"
    },
    {
      "affs": [
        13
      ],
      "name": "Meral BEKSAC"
    },
    {
      "affs": [
        14
      ],
      "name": "Angelo MAIOLINO"
    },
    {
      "affs": [
        15
      ],
      "name": "Jaclyn STANZIOLA"
    },
    {
      "affs": [
        15
      ],
      "name": "Lorena LOPEZ-MASI"
    },
    {
      "affs": [
        16
      ],
      "name": "Matteo LOI"
    },
    {
      "affs": [
        17
      ],
      "name": "Melissa ROWE"
    },
    {
      "affs": [
        18
      ],
      "name": "Sonja ZWEEGMAN"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/abjgz3n4qkq91.bib",
  "cited_by": 0,
  "doi": "10.1016/j.htct.2026.107857",
  "fulltext_url": "http://www.sciencedirect.com/science/article/pii/S2531137926016044",
  "id": "abjgz3n4qkq91",
  "issns": [
    "2531-1379",
    "2531-1387"
  ],
  "landing_url": "https://doi.org/10.1016/j.htct.2026.107857",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "lcc",
      "RC633-647.5"
    ],
    [
      "openalex",
      "2720|Multiple Myeloma Research and Treatments"
    ]
  ],
  "openalex": "W7223102722",
  "pdf_url": "https://www.sciencedirect.com/science/article/pii/S2531137926016044/pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-23",
  "publisher": "Elsevier",
  "ris": "https://research.draconitic.com/paper/abjgz3n4qkq91.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T13:43:36Z",
      "native_id": "bc759874fa7149568587b31e4d70d435",
      "source": "doaj",
      "url": "https://doi.org/10.1016/j.htct.2026.107857"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "lcc:RC633-647.5",
      "subfield": "endocrinology-metabolism"
    }
  ],
  "title": "DARATUMUMAB PLUS BORTEZOMIB, LENALIDOMIDE, AND DEXAMETHASONE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA: FINAL ANALYSIS OF TRANSPLANT-INELIGIBLE PATIENTS IN THE PHASE 3 CEPHEUS STUDY",
  "title_text": "DARATUMUMAB PLUS BORTEZOMIB, LENALIDOMIDE, AND DEXAMETHASONE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA: FINAL ANALYSIS OF TRANSPLANT-INELIGIBLE PATIENTS IN THE PHASE 3 CEPHEUS STUDY",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:43:36Z",
  "url": "https://research.draconitic.com/paper/abjgz3n4qkq91",
  "venue": "Hematology, Transfusion and Cell Therapy",
  "versions": []
}