Evidence map›Paper›PMID 32804408›Full record

Trial reportAmerican journal of hematology2020

Daratumumab-lenalidomide-dexamethasone vs standard-of-care regimens: Efficacy in transplant-ineligible untreated myeloma.

Brian G M Durie, Shaji K Kumar, Saad Z Usmani, Bareng A S Nonyane, Eric M Ammann, Annette Lam, Rachel Kobos, Eric M Maiese, Thierry Facon

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05527340 (Multicenter, Phase II, National and Open-label Study to Evaluate Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.), which is not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
2.7field-weighted citation impact, top 8% 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.

NCT05527340 phase2active not recruitingnot on this mapstarted 2022, after this paper: background citation

Multicenter, Phase II, National and Open-label Study to Evaluate Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

TypeinterventionalSponsorPETHEMA FoundationRan2022 to 2029Enrolled140ConditionsMultiple MyelomaArmsIberdomide, Dexamethasone, Daratumumab
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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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

9 authors at 8 institutions in 3 countries.

Brian G M DurieCedars-Sinai Medical Center, Los Angeles, California, USA.
Shaji K KumarMayo Clinic, Rochester, Minnesota, USA.
Saad Z UsmaniAtrium Health, Charlotte, North Carolina, USA.
Bareng A S NonyaneJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Eric M AmmannJanssen Scientific Affairs, Horsham, Pennsylvania, USA.
Annette LamJanssen Global Services, Raritan, New Jersey, USA.
Rachel KobosJanssen Research & Development, Raritan, New Jersey, USA.
Eric M MaieseJanssen Scientific Affairs, Horsham, Pennsylvania, USA.
Thierry FaconDepartment of Haematology, Lille University Hospital, Lille, France.
Janssen (United States) · USAtrium Medical Cente · USCedars-Sinai Medical Center · USJanssen (Belgium) · BEJanssen Scientific Affairs (United States)Johns Hopkins University · USLille’s Cardiology Hospital · FRMayo Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Daratumumab in combination with lenalidomide-dexamethasone (D-Rd) recently received FDA approval for the treatment of transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). The present PEGASUS study compared progression-free survival (PFS) in patients treated with D-Rd in the MAIA trial and patients treated with common standard-of-care regimens from the Flatiron Health electronic health record-derived deidentified database, which has data from patients treated primarily at community-based oncology practices in the United States. Individual-level patient data from both data sources were used to perform an anchored indirect treatment comparison (ITC) of D-Rd to bortezomib-lenalidomide-dexamethasone (VRd) and bortezomib-dexamethasone (Vd); lenalidomide-dexamethasone (Rd) was the common anchor for the ITC. Hazard ratios (HRs) reflecting direct comparisons of PFS within MAIA (D-Rd vs Rd) and Flatiron Health (VRd vs Rd; Vd vs Rd) were used to make ITCs for D-Rd vs VRd and Vd, respectively. After application of MAIA inclusion/exclusion criteria and propensity-score weighting, the Flatiron Health patients resembled the MAIA trial population on measured baseline characteristics. Based on the direct comparison within MAIA, treatment with D-Rd was associated with a significantly lower risk of progression or death compared to Rd (HR 0.54; 95% CI 0.42, 0.71). Based on the ITCs, D-Rd was associated with a significantly lower risk of progression or death compared to VRd (HR 0.68; 95% CI 0.48, 0.98) and Vd (HR 0.48; 95% CI 0.33, 0.69). In the absence of head-to-head trials comparing D-Rd to VRd or Vd, the present ITC may help inform treatment selection in transplant-ineligible patients with NDMM.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneDisease-Free SurvivalFemaleHumansLenalidomideMaleMultiple MyelomaSurvival RateAntibodies, MonoclonaldaratumumabDexamethasoneLenalidomide

Identifiers

PMID32804408
PMCPMC7754114
OpenAlexW3049547584

What OpenQuestion holds

Textmetadata
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.