Evidence map›Paper›PMID 36111391›Full record

Trial reportBritish journal of haematology2022

Daratumumab plus lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma: Analysis of vascular thrombotic events in the GRIFFIN study.

Douglas W Sborov, Muhamed Baljevic, Brandi Reeves, Jacob Laubach, Yvonne A Efebera, Cesar Rodriguez, Luciano J Costa, Ajai Chari, Rebecca Silbermann, Sarah A Holstein and 11 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02874742 (Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 6% 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.

NCT02874742 phase2completednot on this map

Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation

TypeinterventionalSponsorJanssen Research & Development, LLCRan2016 to 2022Enrolled224ConditionsMultiple MyelomaArmsLenalidomide, Bortezomib, Dexamethasone, Daratumumab
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Cancer-associated thrombosis in hematologic malignancies.International journal of hematology · 2024
    Review
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 16 institutions in 2 countries.

Douglas W SborovHuntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah, USA.ORCID 0000-0003-4268-2698
Muhamed BaljevicDivision of Oncology & Hematology, Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Brandi ReevesUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Jacob LaubachDana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID 0000-0001-7565-2052
Yvonne A EfeberaOhioHealth, Columbus, Ohio, USA.
Cesar RodriguezWake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Luciano J CostaUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID 0000-0001-5362-2469
Ajai ChariTisch Cancer Institute, Mount Sinai School of Medicine, New York, New York, USA.
Rebecca SilbermannKnight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.
Sarah A HolsteinDivison of Oncology & Hematology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Larry D AndersonSimmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0002-6531-9595
Jonathan L KaufmanWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.ORCID 0000-0002-5687-6429
Nina ShahDepartment of Medicine, University of California San Francisco, San Francisco, California, USA.
Huiling PeiJanssen Research & Development, LLC, Titusville, New Jersey, USA.
Sharmila PatelJanssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.
Annelore CortoosJanssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.
J Blake BartlettJanssen Research & Development, LLC, Raritan, New Jersey, USA.
Jessica VermeulenJanssen Research & Development, LLC, Leiden, The Netherlands.
Thomas S LinJanssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.
Peter M VoorheesLevine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA.ORCID 0000-0003-1661-718X
Paul G RichardsonDana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID 0000-0002-7426-8865
Janssen (United States) · USDana-Farber Cancer Institute · USEmory University · USJanssen (Netherlands) · NLLevine Cancer Institute · USNebraska Medical Center · USOhioHealth · USOregon Health & Science University · USSouthwestern Medical Center · USTisch Hospital · USUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · USUniversity of Utah · USVanderbilt University Medical Center · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with multiple myeloma are at increased risk of vascular thromboembolic events (VTEs). This post hoc analysis evaluated VTEs in the randomised phase 2 GRIFFIN study (ClinicalTrials.gov Identifier: NCT02874742) that investigated lenalidomide/bortezomib/dexamethasone (RVd) ± daratumumab (D). Patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplantation (ASCT) received D-RVd/RVd induction, high-dose therapy and ASCT, D-RVd/RVd consolidation and up to 2 years of lenalidomide maintenance therapy ± D. VTE prophylaxis was recommended (at least aspirin, ≥162 mg daily) in accordance with International Myeloma Working Group guidelines. In the safety population (D-RVd, n = 99; RVd, n = 102), VTEs occurred in 10.1% of D-RVd patients and 15.7% of RVd patients; grade 2-4 VTEs occurred in 9.1% and 14.7%, respectively. Median time to the first onset of VTE was longer for D-RVd versus RVd patients (305 days vs 119 days). Anti-thrombosis prophylaxis use was similar between arms (D-RVd, 84.8% vs RVd, 83.3%); among patients with VTEs, prophylaxis use at time of first VTE onset was 60.0% for D-RVd and 68.8% for RVd. In summary, the addition of daratumumab to RVd did not increase the incidence of VTEs, but the cumulative VTE incidence was relatively high in this cohort and anti-thrombotic prophylaxis use was suboptimal.

Indexed as

Hematopoietic Stem Cell TransplantationMultiple MyelomaVenous ThromboembolismAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsAspirinBortezomibDexamethasoneHumansLenalidomideTransplantation, AutologousAntibodies, MonoclonalAspirinBortezomibdaratumumabDexamethasoneLenalidomidedaratumumabGRIFFINnewly diagnosed multiple myelomaprophylaxisvascular thromboembolic eventsVTEs

Identifiers

PMID36111391
PMCPMC9825872
OpenAlexW4296034616

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.