Evidence map›Paper›PMID 33097687›Full record

Trial reportBlood cancer journal2020

Single-agent belantamab mafodotin for relapsed/refractory multiple myeloma: analysis of the lyophilised presentation cohort from the pivotal DREAMM-2 study.

Paul G Richardson, Hans C Lee, Al-Ola Abdallah, Adam D Cohen, Prashant Kapoor, Peter M Voorhees, Axel Hoos, Karrie Wang, January Baron, Trisha Piontek and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood cancer journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03525678 (A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
5.2field-weighted citation impact, top 3% 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.

NCT03525678 phase2completednot on this map

A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2024Enrolled221ConditionsMultiple MyelomaArmsBelantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  17. Anti-BCMA novel therapies for multiple myeloma.Cancer drug resistance (Alhambra, Calif.) · 2023
    Review
  18. Review
  19. Article
  20. Review
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

16 authors at 9 institutions in 1 country.

Paul G RichardsonDana Farber Cancer Institute, Boston, MA, USA.
Hans C LeeMD Anderson Cancer Center, Houston, TX, USA.
Al-Ola AbdallahUniversity of Kansas Cancer Center, Fairway, KS, USA.
Adam D CohenAbramson Cancer Center, University of Philadelphia, Philadelphia, PA, USA.ORCID 0000-0003-0939-3843
Prashant KapoorMayo Clinic, Rochester, MN, USA.
Peter M VoorheesLevine Cancer Institute, Atrium Health, Charlotte, NC, USA.
Axel HoosGlaxoSmithKline, Philadelphia, PA, USA.
Karrie WangGlaxoSmithKline, Philadelphia, PA, USA.
January BaronGlaxoSmithKline, Philadelphia, PA, USA.
Trisha PiontekGlaxoSmithKline, Philadelphia, PA, USA.
Julie ByrneGlaxoSmithKline, Philadelphia, PA, USA.
Scott RichmondGlaxoSmithKline, Rockville, MD, USA.
Roxanne C JewellGlaxoSmithKline, Research Triangle Park, NC, USA.
Joanna OpalinskaGlaxoSmithKline, Philadelphia, PA, USA.
Ira GuptaGlaxoSmithKline, Philadelphia, PA, USA.
Sagar LonialEmory University, Winship Cancer Institute, Atlanta, GA, USA. sloni01@emory.edu.ORCID 0000-0002-8322-9323
GlaxoSmithKline (United States) · USAbramson Cancer CenterDana-Farber Cancer Institute · USEmory University · USLevine Cancer Institute · USMayo Clinic in Arizona · USResearch Triangle Park Foundation · USThe University of Kansas Cancer Center · USThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

DREAMM-2 (NCT03525678) is an ongoing global, open-label, phase 2 study of single-agent belantamab mafodotin (belamaf; GSK2857916), a B-cell maturation antigen-targeting antibody-drug conjugate, in a frozen-liquid presentation in patients with relapsed/refractory multiple myeloma (RRMM). Alongside the main study, following identical inclusion/exclusion criteria, a separate patient cohort was enrolled to receive belamaf in a lyophilised presentation (3.4 mg/kg, every 3 weeks) until disease progression/unacceptable toxicity. Primary outcome was independent review committee-assessed overall response rate (ORR). Twenty-five patients were enrolled; 24 received ≥1 dose of belamaf. As of 31 January 2020, ORR was 52% (95% CI: 31.3-72.2); 24% of patients achieved very good partial response. Median duration of response was 9.0 months (2.8-not reached [NR]); median progression-free survival was 5.7 months (2.2-9.7); median overall survival was not reached (8.7 months-NR). Most common grade 3/4 adverse events were keratopathy (microcyst-like corneal epithelial changes, a pathological finding seen on eye examination [75%]), thrombocytopenia (21%), anaemia (17%), hypercalcaemia and hypophosphatemia (both 13%), neutropenia and blurred vision (both 8%). Pharmacokinetics supported comparability of frozen-liquid and lyophilised presentations. Single-agent belamaf in a lyophilised presentation (intended for future use) showed a deep and durable clinical response and acceptable safety profile in patients with heavily pre-treated RRMM.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedDisease-Free SurvivalFemaleHumansMaleMiddle AgedMultiple MyelomaRecurrenceSurvival RateAntibodies, Monoclonal, Humanizedbelantamab mafodotin

Identifiers

PMID33097687
PMCPMC7584571
OpenAlexW3093772338

What OpenQuestion holds

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LicenceCC BY
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.