Evidence map›Paper›PMID 41545603›Full record

Trial reportAnnals of hematology2026

Plitidepsin in combination with dexamethasone (ADMYRE trial) versus an external control arm of pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma.

Heinz Ludwig, Evangelos Terpos, Mario Boccadoro, Sara Martínez, Carmen Kahatt, Javier Jiménez, Antonio Nieto, Sonia Extremera, Javier Gómez, Vicente Alfaro and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIComparative Study
In one paragraph

Trial report in Annals of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

13 authors.

Heinz LudwigDepartment of Medicine, Center for Oncology, Hematology and Palliative Care, Wilhelminen Cancer Research Institute, Wilhelminen Hospital, Vienna, Austria.
Evangelos TerposDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Mario BoccadoroEuropean Myeloma Network, EMN, Torino, Italy.
Sara MartínezClinical R&D, Pharma Mar, Colmenar Viejo, Madrid, Spain.
Carmen KahattClinical R&D, Pharma Mar, Colmenar Viejo, Madrid, Spain.
Javier JiménezClinical R&D, Pharma Mar, Colmenar Viejo, Madrid, Spain.
Antonio NietoClinical R&D, Pharma Mar, Colmenar Viejo, Madrid, Spain.
Sonia ExtremeraClinical R&D, Pharma Mar, Colmenar Viejo, Madrid, Spain.
Javier GómezClinical R&D, Pharma Mar, Colmenar Viejo, Madrid, Spain.
Vicente AlfaroClinical R&D, Pharma Mar, Colmenar Viejo, Madrid, Spain.
Ruthanna DaviMedidata AI , Medidata Solutions, a Dassault Systèmes Company, New York, U.S.
Xiang YinMedidata AI , Medidata Solutions, a Dassault Systèmes Company, New York, U.S.
María Victoria MateosDepartamento de Hematología, Hospital Universitario de Salamanca. Paseo de San Vicente, Salamanca, 58-182. 37007, Spain. mvmateos@usal.es.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Plitidepsin (P) is a marine-derived anticancer compound isolated from the tunicate Aplidium albicans. P plus low-dose dexamethasone (LD-DXM) was evaluated versus LD-DXM alone in patients with relapsed/refractory multiple myeloma (r/r MM) in the randomized phase III ADMYRE trial. In absence of a randomized study with P + LD-DXM vs. POM + LD-DXM, a direct matched comparison between P + LD-DXM (ADMYRE data) and pomalidomide (POM) + LD-DXM as an External Control Arm (ECA) was conducted using individual patient-level data from several contemporary POM + LD-DXM trials with a similar design. A first analysis (ECA1) showed that P + LD-DXM was non-inferior to POM + LD-DXM in terms of median overall survival (OS): 11.8 vs. 13.9 months; HR = 1.009 (95%CI, 0.812–1.254; p = 0.9336). Safety profile showed a lower rate of grade ≥ 3 hematological treatment-related adverse events (TRAEs) (neutropenia 2.5% vs. 37.1%; thrombocytopenia 2.5% vs. 13.2%) and infections (8.1% vs. 18.7%) for P + LD-DXM, and a higher rate of grade ≥ 1 gastrointestinal TRAEs (52.8% vs. 27.4%), grade ≥ 3 blood creatine phosphokinase (14.3% vs. 0%) and grade ≥ 3 myalgia (5.6% vs. 0%). A second analysis (ECA2) compared POM + LD-DXM with the LD-DXM alone arm included in ADMYRE and showed a treatment effect in OS (HR = 0.762; 95%CI, 0.566–1.026) similar to that observed in ADMYRE (HR = 0.797, 95%CI, 0.596–1.067). Safety profile of POM + LD-DXM was associated to a higher rate of TRAEs, as expected for a combination. In conclusion, P + LD-DXM can be an alternative therapeutic option in r/r MM as this comparison shows that P + LD-DXM is non-inferior in OS to POM + LD-DXM with an advantageous safety profile in terms of hematological and infection events.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsDepsipeptidesDexamethasoneMultiple MyelomaThalidomideAgedFemaleHumansMaleMiddle AgedDepsipeptidesDexamethasoneplitidepsinpomalidomideThalidomideExternal control armLow-dose dexamethasonePlitidepsinPomalidomide

Identifiers

PMID41545603
PMCPMC12811270

What OpenQuestion holds

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Registered trials

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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.