Evidence map›Paper›PMID 34269818›Full record

Trial reportBlood2022

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

Jesus San-Miguel, Hervé Avet-Loiseau, Bruno Paiva, Shaji Kumar, Meletios A Dimopoulos, Thierry Facon, María-Victoria Mateos, Cyrille Touzeau, Andrzej Jakubowiak, Saad Z Usmani and 17 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 83 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 2 pooled it
14.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02195479 phase3completednot on this map

A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2024Enrolled706ConditionsMultiple MyelomaArmsVelcade, Melphalan, Prednisone, Daratumumab IV, Dexamethasone
NCT02252172 phase3completednot on this map

A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

TypeinterventionalSponsorJanssen Research & Development, LLCRan2015 to 2024Enrolled737ConditionsMultiple MyelomaArmsDaratumumab IV, Lenalidomide, Dexamethasone, Daratumumab SC
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 2 syntheses or guidelines pooled it, 134 citations in OpenAlex.

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  10. Teclistamab in Relapsed or Refractory Multiple Myeloma.The New England journal of medicine · 2022
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  11. Measurable Residual Disease.Methods in molecular biology (Clifton, N.J.) · 2027
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23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 13 institutions in 10 countries.

Jesus San-MiguelClínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de Investigación Sanitaria de Navarra (IDISNA), CIBER-ONC number CB16/12/00369, Pamplona, Spain.ORCID 0000-0002-9183-4857
Hervé Avet-LoiseauUnite de Genomique du Myelome, IUC-Oncopole, Toulouse, France.
Bruno PaivaClínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de Investigación Sanitaria de Navarra (IDISNA), CIBER-ONC number CB16/12/00369, Pamplona, Spain.ORCID 0000-0003-1977-3815
Shaji KumarDepartment of Hematology, Mayo Clinic, Rochester, MN.ORCID 0000-0001-5392-9284
Meletios A DimopoulosNational and Kapodistrian University of Athens, Athens, Greece.
Thierry FaconUniversity of Lille, CHU Lille, Service des Maladies du Sang, Lille, France.
María-Victoria MateosUniversity Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain.ORCID 0000-0003-2390-1218
Cyrille TouzeauHematology, University Hospital Hôtel-Dieu, Nantes, France.
Andrzej JakubowiakUniversity of Chicago Medical Center, Chicago, IL.
Saad Z UsmaniLevine Cancer Institute/Atrium Health, Charlotte, NC.
Gordon CookLeeds Cancer Centre, Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, United Kingdom.
Michele CavoIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," Università di Bologna, Bologna, Italy.
Hang QuachUniversity of Melbourne, St. Vincent's Hospital, Melbourne, VIC.ORCID 0000-0002-4796-3352
Jon UkropecJanssen Global Medical Affairs, Horsham, PA.
Priya RamaswamiJanssen Research & Development, LLC, Titusville, NJ.
Huiling PeiJanssen Research & Development, LLC, Titusville, NJ.
Mia QiJanssen Research & Development, LLC, Raritan, NJ.
Steven SunJanssen Research & Development, LLC, Raritan, NJ.
Jianping WangJanssen Research & Development, LLC, Raritan, NJ.
Maria KrevvataJanssen Research & Development, LLC, Spring House, PA.
Nikki DeAngelisJanssen Research & Development, LLC, Spring House, PA.
Christoph HeuckJanssen Research & Development, LLC, Spring House, PA.
Rian Van RampelberghJanssen Research & Development, Beerse, Belgium; and.
Anupa KudvaJanssen Research & Development, LLC, Raritan, NJ.
Rachel KobosJanssen Research & Development, LLC, Raritan, NJ.
Ming QiJanssen Research & Development, LLC, Spring House, PA.
Nizar J BahlisArnie Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada.
Janssen (United States) · USNavarre Institute of Health Research · ESInstituto de Investigación Biomédica de Salamanca · ESIstituto di Ematologia di Bologna · ITJanssen (Belgium) · BELevine Cancer Institute · USMayo Clinic in Arizona · USNational and Kapodistrian University of Athens · GRSt. Vincent's Birmingham · USUniversité de Lille · FRUniversity of Calgary · CAUniversity of Chicago Medical Center · USUniversity of Leeds · GB

Funding

Targeting Genomic Instability and Evolution in MyelomaP01CA155258 · NCI · DANA-FARBER CANCER INST · PI Jill Corre · 2011 to 2026
$32.5M
NCI NIH HHS P01 CA155258
6 · The paper itself

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).

Indexed as

AgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedMultiple MyelomaNeoplasm, ResidualProgression-Free SurvivalTreatment OutcomeAntibodies, Monoclonaldaratumumab

Identifiers

PMID34269818
PMCPMC8796656
OpenAlexW3180549397

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.