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Cited by 153Multiple Myeloma Research and TreatmentsChronic Lymphocytic Leukemia ResearchLymphoma Diagnosis and Treatment

The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.

Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE

Open access
San-Miguel, Jesus, Avet-Loiseau, Hervé, Paiva, Bruno, Kumar, Shaji, Dimopoulos, Meletios A., Facon, Thierry, Mateos, María-Victoria, Touzeau, Cyrille, Jakubowiak, Andrzej, Usmani, Saad Z., Cook, Gordon, Cavo, Michele, Quach, Hang, Ukropec, Jon, Ramaswami, Priya, Pei, Huiling, Qi, Mia, Sun, Steven, Wang, Jianping, Krevvata, Maria, DeAngelis, Nikki, Heuck, Christoph, Van Rampelbergh, Rian, Kudva, Anupa, Kobos, Rachel, Qi, Ming, Bahlis, Nizar J.·2022·Blood
DOI 10.1182/blood.2020010439PMC PMC8796656
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Abstract

In patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), daratumumab reduced the risk of disease progression or death by 44% in MAIA (daratumumab/lenalidomide/dexamethasone [D-Rd]) and 58% in ALCYONE (daratumumab/bortezomib/melphalan/prednisone [D-VMP]). Minimal residual disease (MRD) is a sensitive measure of disease and response to therapy. MRD-negativity status and durability were assessed in MAIA and ALCYONE. MRD assessments using next-generation sequencing (10−5) occurred for patients achieving complete response (CR) or better and after at least CR at 12, 18, 24, and 30 months from the first dose. Progression-free survival (PFS) by MRD status and sustained MRD negativity lasting ≥6 and ≥12 months were analyzed in the intent-to-treat population and among patients achieving at least CR. In MAIA (D-Rd, n = 368; lenalidomide and dexamethasone [Rd], n = 369) and ALCYONE (D-VMP, n = 350; bortezomib/melphalan/prednisone [VMP], n = 356), the median duration of follow-up was 36.4 and 40.1 months, respectively. MRD-negative status and sustained MRD negativity lasting ≥6 and ≥12 months were associated with improved PFS, regardless of treatment group. However, daratumumab-based therapy improved rates of MRD negativity lasting ≥6 months (D-Rd, 14.9% vs Rd, 4.3%; D-VMP, 15.7% vs VMP, 4.5%) and ≥12 months (D-Rd, 10.9% vs Rd, 2.4%; D-VMP, 14.0% vs VMP, 2.8%), both of which translated to improved PFS vs control groups. In a pooled analysis, patients who were MRD negative had improved PFS vs patients who were MRD positive. Patients with NDMM who achieved MRD-negative status or sustained MRD negativity had deep remission and improved clinical outcomes. These trials were registered at www.clinicaltrials.gov as #NCT02252172 (MAIA) and #NCT02195479 (ALCYONE).

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Research works printed but not linked: 2

  1. Darzalex (daratumumab), 2020, Package insert.
  2. Adaptive Biotechnologies Corporation, 2018, clonoSEQ® Assay Technical Information.

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Metadata

Authors
San-Miguel, J., Avet-Loiseau, H., Paiva, B., Kumar, S., Dimopoulos, M. A., Facon, T., Mateos, M.-V., Touzeau, C., Jakubowiak, A., Usmani, S. Z., Cook, G., Cavo, M., Quach, H., Ukropec, J., Ramaswami, P., Pei, H., Qi, M., Sun, S., Wang, J., Krevvata, M., DeAngelis, N., Heuck, C., Van Rampelbergh, R., Kudva, A., Kobos, R., Qi, M., & Bahlis, N. J.
Affiliations
  • Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de Investigación Sanitaria de Navarra (IDISNA), CIBER-ONC number CB16/12/00369, Pamplona, Spain;
  • Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France;
  • Navarre Institute of Health Research (ES)
  • Mayo Clinic (US)
  • National and Kapodistrian University of Athens (GR)
  • Université de Lille (FR)
  • Universidad de Salamanca (ES)
  • Centre Hospitalier Universitaire de Nantes (FR)
  • University of Chicago Medical Center (US)
  • Levine Cancer Institute (US)
  • University of Leeds (GB)
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli,” Università di Bologna, Bologna, Italy;
  • The University of Melbourne (AU)
  • Janssen Global Medical Affairs, Horsham, PA;
  • Janssen Research & Development, LLC, Titusville, NJ;
  • Janssen Research & Development (United States) (US)
  • Janssen Research & Development, LLC, Spring House, PA;
  • Janssen Research & Development, Beerse, Belgium; and
  • University of Calgary (CA)
ORCID
Venue
Blood
Publisher
American Society of Hematology
Published
2022-01-27
Volume
139
Issue
4
Pages
492-501
ISSN
  • 0006-4971 (ISSN-L)
  • 1528-0020
DOI
10.1182/blood.2020010439
PMC
PMC8796656
OpenAlex
W3180549397
Cited by
153
References
25
Citations by year
2026: 22 · 2025: 28 · 2024: 39 · 2023: 38 · 2022: 21
FWCI
16.63
Type
journal article
Language
en
Open access
Locations
  • Blood (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
  • DIGITAL.CSIC (Spanish National Research Council (CSIC)) (submittedVersion)
Funders
National Cancer Institute (P01CA155258)
Topics
  • Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
  • Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
Keywords
multiple myeloma, newly diagnosed multiple myeloma, minimal residual disease, daratumumab, progression-free survival, lenalidomide, bortezomib, melphalan, complete response, deep remission, CAR T-cell therapy
MeSH terms
Progression-Free Survival, Aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Male, Middle Aged, Multiple Myeloma, Treatment Outcome, Neoplasm, Residual

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