{
  "abstract": "Advancements in frontline therapies have substantially improved outcomes in newly diagnosed multiple myeloma (NDMM); however, many patients will not achieve deep responses and will relapse. Teclistamab, a BCMA×CD3 bispecific antibody, in combination with daratumumab, has demonstrated strong efficacy in relapsed/refractory multiple myeloma versus standard of care as early as first relapse. This ongoing phase 2 GMMG-HD10/DSMM-XX (MajesTEC-5) study evaluates teclistamab-based regimens in transplant-eligible NDMM. In this prespecified pooled analysis of three cohorts, 49 patients received teclistamab/daratumumab/lenalidomide (Tec-DR; arms A and A1) or Tec-DR with bortezomib (Tec-DVR; arm B). Primary endpoints were incidence and severity of adverse events (AEs) and serious AEs; secondary endpoints included overall response rate (ORR), minimal residual disease (MRD) negativity and MRD-negative complete response (CR). The current analysis spans the induction and autologous stem cell transplantation phases until the premaintenance timepoint. Grade 3 or 4 treatment-emergent AEs (TEAEs) occurred in 91.8% (45/49); most were hematologic (lymphopenia (59.2%; 29/49), neutropenia (59.2%; 29/49) and leukopenia (18.4%; 9/49)). No grade 5 TEAEs were reported. Serious AEs occurred in 55.1% (27/49); pyrexia (12.2% (6/49)) was most common. Any-grade and grade 3 or 4 infections occurred in 81.6% (40/49) and 36.7% (18/49), respectively, the most common grade 3 or 4 infections being COVID-19 and pneumonia (6.1% (3/49) each). Cytokine release syndrome occurred in 67.3% (33/49); all were grade 1 or 2, all resolved and none led to discontinuation of any study treatment. No treatment-related immune effector cell-associated neurotoxicity syndrome (ICANS) events occurred. Across arms, the MRD-negative CR rate was 91.8% (45/49) by the premaintenance timepoint; the MRD negativity rate was 100% in evaluable samples at postinduction cycle 3 (1 × 10 −5 (46/46)), cycle 6 (1 × 10 −5 (46/46) and 1 × 10 −6 (46/46)) and premaintenance (1 × 10 −5 (40/40)); the ORR was 100% (49/49). Total median stem cell yield was 8.1 × 10 6 per kg. Data support the feasibility of Tec-D(V)R induction in transplant-eligible NDMM, with a consistent safety profile compared with individual regimen components and notable early MRD negativity rates. ClinicalTrials.gov identifier: NCT05695508 .",
  "abstract_shown": true,
  "affiliations": [
    "Heidelberg Myeloma Center and GMMG Study Group, Department of Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg, Germany. marc.raab@med.uni-heidelberg.de",
    "Heidelberg Myeloma Center and GMMG Study Group, Department of Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg, Germany",
    "Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany",
    "Department of Hematology, Oncology, and Tumor Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany",
    "Deutsches Konsortium für Translationale Krebsforschung (DKTK), Partner Site Berlin, Berlin, Germany",
    "Department of Hematology, Oncology and Clinical Immunology, University Hospital Düsseldorf, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany",
    "University Medical Center Hamburg-Eppendorf, Hamburg, Germany",
    "Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany",
    "Coordination Centre for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany",
    "Department of Internal Medicine II, Division of Stem Cell Transplantation and Immunotherapy, Universitätsklinikum Schleswig-Holstein (UKSH) Campus Kiel, Kiel, Germany",
    "Bayerisches Zentrum für Krebsforschung (BZKF), Munich, Germany",
    "Department of Medicine III, TUM Klinikum, Technische Universität München, München, Germany",
    "Deutsches Konsortium für Translationale Krebsforschung (DKTK), Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Germany",
    "Johnson & Johnson, Spring House, PA, USA",
    "Johnson & Johnson, Paris, France",
    "Johnson & Johnson, High Wycombe, UK",
    "Johnson & Johnson, Beerse, Belgium",
    "Johnson & Johnson, Leiden, The Netherlands",
    "Department of Hematology, Oncology and Stem Cell Transplantation, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany",
    "Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany",
    "Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona and Asklepios Klinik St. Georg, Hamburg, Germany",
    "Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus an der Technische Universität Dresden, Dresden, Germany",
    "Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany. Rasche_L@ukw.de"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 33,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Marc Steffen Raab",
      "orcid": "0000-0003-4181-6922"
    },
    {
      "affs": [
        1
      ],
      "name": "Niels Weinhold",
      "orcid": "0000-0002-5464-3234"
    },
    {
      "affs": [
        2
      ],
      "name": "Klaus Martin Kortüm",
      "orcid": "0000-0002-7011-0286"
    },
    {
      "affs": [
        3,
        4
      ],
      "name": "Jan Krönke",
      "orcid": "0000-0002-4649-0506"
    },
    {
      "affs": [
        5
      ],
      "name": "Roland R. Fenk",
      "orcid": "0000-0001-7594-6288"
    },
    {
      "affs": [
        6
      ],
      "name": "Katja Christina Weisel",
      "orcid": "0000-0001-9422-6614"
    },
    {
      "affs": [
        1
      ],
      "name": "Lilli Podola"
    },
    {
      "affs": [
        1
      ],
      "name": "Uta Bertsch",
      "orcid": "0000-0001-5584-3951"
    },
    {
      "affs": [
        7
      ],
      "name": "Alexander Brobeil",
      "orcid": "0000-0002-1003-8577"
    },
    {
      "affs": [
        2
      ],
      "name": "Julia Mersi",
      "orcid": "0009-0008-7651-8080"
    },
    {
      "affs": [
        1
      ],
      "name": "Stefanie Huhn",
      "orcid": "0000-0003-1700-2371"
    },
    {
      "affs": [
        8
      ],
      "name": "Ryan Arlinghaus"
    },
    {
      "affs": [
        1
      ],
      "name": "Michael Hundemer",
      "orcid": "0000-0002-5596-2405"
    },
    {
      "affs": [
        3
      ],
      "name": "Stephan Bohl",
      "orcid": "0000-0001-9379-3342"
    },
    {
      "affs": [
        1
      ],
      "name": "Elias Karl Mai",
      "orcid": "0000-0002-6226-1252"
    },
    {
      "affs": [
        9
      ],
      "name": "Natalie Schub",
      "orcid": "0009-0002-7407-5075"
    },
    {
      "affs": [
        2
      ],
      "name": "Johannes Moritz Waldschmidt",
      "orcid": "0000-0001-5340-1818"
    },
    {
      "affs": [
        10,
        11,
        12
      ],
      "name": "Florian C. Bassermann",
      "orcid": "0000-0003-4435-2609"
    },
    {
      "affs": [
        1
      ],
      "name": "Carsten Müller‐Tidow",
      "orcid": "0000-0002-7166-5232"
    },
    {
      "affs": [
        13
      ],
      "name": "Christoph Johann Heuck"
    },
    {
      "affs": [
        14
      ],
      "name": "Caline Sakabedoyan"
    },
    {
      "affs": [
        15
      ],
      "name": "Josephine Khan"
    },
    {
      "affs": [
        16
      ],
      "name": "Elena Ershova"
    },
    {
      "affs": [
        17
      ],
      "name": "Bas D. Koster",
      "orcid": "0000-0002-3889-5132"
    },
    {
      "affs": [
        18
      ],
      "name": "Monika Martha Engelhardt",
      "orcid": "0000-0003-0405-1676"
    },
    {
      "affs": [
        19
      ],
      "name": "Mathias Hänel",
      "orcid": "0000-0002-4767-3275"
    },
    {
      "affs": [
        20
      ],
      "name": "Hans Jürgen Salwender",
      "orcid": "0000-0001-7803-0814"
    },
    {
      "affs": [
        21
      ],
      "name": "Raphael Teipel",
      "orcid": "0000-0002-9985-6583"
    },
    {
      "affs": [
        1
      ],
      "name": "Hartmut Goldschmidt",
      "orcid": "0000-0003-0961-0035"
    },
    {
      "affs": [
        2
      ],
      "name": "Hermann Einsele",
      "orcid": "0000-0002-7680-0819"
    },
    {
      "affs": [
        22
      ],
      "name": "Leo Rasche",
      "orcid": "0000-0002-9536-9649"
    },
    {
      "name": "on behalf of the GMMG-HD10/DSMM-XX (MajesTEC-5) investigators"
    },
    {
      "affs": [
        2
      ],
      "name": "K. Martin Kortüm",
      "orcid": "0000-0002-7011-0286"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/324ves3c7kekg.bib",
  "cited_by": 8,
  "doi": "10.1038/s41591-026-04471-x",
  "fulltext_url": null,
  "id": "324ves3c7kekg",
  "issns": [
    "1078-8956",
    "1546-170X",
    "1744-7933"
  ],
  "landing_url": "https://doi.org/10.1038/s41591-026-04471-x",
  "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": [
    [
      "openalex",
      "2720|Multiple Myeloma Research and Treatments"
    ]
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  "openalex": "W7165851632",
  "pdf_url": "https://www.nature.com/articles/s41591-026-04471-x.pdf",
  "pmcid": "PMC13375549",
  "pmid": "42350642",
  "published": "2026-06-25",
  "publisher": "Nature Portfolio",
  "ris": "https://research.draconitic.com/paper/324ves3c7kekg.ris",
  "sources": [
    {
      "first_seen": "2026-10-31T13:20:51Z",
      "native_id": "W7165851632",
      "source": "openalex",
      "url": "https://doi.org/10.1038/s41591-026-04471-x"
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2720|Multiple Myeloma Research and Treatments",
      "subfield": "general"
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  ],
  "title": "Teclistamab-based induction treatment in transplant-eligible, newly diagnosed multiple myeloma: a phase 2 trial",
  "title_text": "Teclistamab-based induction treatment in transplant-eligible, newly diagnosed multiple myeloma: a phase 2 trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-03T13:20:37Z",
  "url": "https://research.draconitic.com/paper/324ves3c7kekg",
  "venue": "Nature Medicine",
  "versions": []
}