Evidence map›Paper›PMID 41927857›Full record

Trial reportCancer medicine2026

Lenalidomide Plus Dexamethasone as FIRST-Line Therapy in Transplant-Ineligible Patients With Multiple Myeloma: Final Results of the Prospective, Non-Interventional Study FIRST-NIS and Comparison With the FIRST Pivotal Phase III Clinical Trial.

H Nückel, T Behlendorf, H Schulz, M Schulze, C Schardt, T Medinger, M Koenigsmann, T Dechow, M Indorf, D Bürkle and 6 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase IIIComparative Study
In one paragraph

Trial report in Cancer medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02537808 (A Non-interventional Study of Lenalidomide), which is not on this 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.

NCT02537808 completednot on this map

A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma

TypeobservationalSponsoriOMEDICO AGRan2015 to 2023Enrolled172ConditionsMultiple Myeloma
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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.

H NückelHämatologisch/Onkologische Gemeinschaftspraxis Prof. Dr. Nückel/Dr. Matschke, Bochum, Germany.
T BehlendorfMVZ III Onkologie der Evidia MVZ Halle (Saale) GmbH, Halle (Saale), Germany.
H SchulzPraxis Internistischer Onkologie und Hämatologie (PIOH), Frechen, Germany.
M SchulzePraxis und Tagesklinik für Hämatologie/Onkologie, Zittau, Germany.
C SchardtGemeinschaftspraxis Dres. Schardt & Azeh, Gelsenkirchen, Germany.
T MedingeriOMEDICO, Freiburg, Germany.
M KoenigsmannMediProjekt GbR, Hannover, Germany.
T DechowStudienzentrum Onkologie Ravensburg, Ravensburg, Germany.
M IndorfiOMEDICO, Freiburg, Germany.
D BürkleZentrum für Ambulante Onkologie, Schorndorf, Germany.
V EngelbertzMVZ Onkologie an der St. Marien-Hospital gGmbH, Düren, Germany.
J RauhGIM Gemeinschaftspraxis für Innere Medizin, Studien- und Fortbildungs GbR, Witten, Germany.
B SchmidtHämatologie und Onkologie München Pasing MVZ GmbH, Munich, Germany.
A SauerBAG Onkologie am Filmpark, Potsdam, Germany.
C VannieriOMEDICO, Freiburg, Germany.
K PotthoffiOMEDICO, Freiburg, Germany.ORCID https://orcid.org/0000-0003-1015-9624

Funding

Celgene GmbH/BMS GmbH & Co. KGaA
6 · The paper itself

Abstract

objectivesLenalidomide and low-dose dexamethasone (Rd) is a standard regimen for transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM), for whom a multi-drug treatment regimen is not considered appropriate. While Rd has been intensively investigated in clinical trials, prospective real-world data are still scarce. PATIENTS AND

methodsThe prospective, multicenter, non-interventional study FIRST-NIS (NTC02537808) investigated the effectiveness, safety, and quality of life (QoL) of Rd in a German real-world setting. G8-Geriatric assessment was used to assess patients' impairment status. Patients were treated according to the physician's discretion. Data were analyzed descriptively; no formal hypothesis was tested.

resultsBetween 2015 and 2018, 168 patients with TIE NDMM were included, median age was 77.7 years. With a median follow-up of 64.2 months, median progression-free survival (PFS) in the real-world setting was 22.9 months [95% CI 19.3, 28.1], median overall survival (OS) 58.1 months [95% CI 45.7, 71.7]. Patients ≤ 75 years and non-impaired patients showed a more favorable PFS and OS, and Rd was a feasible treatment option in most patients with renal impairment. QoL was maintained during Rd treatment. No new safety signals emerged.

conclusionsThe results of the FIRST-NIS support Rd as an effective and safe frontline treatment option for patients with TIE NDMM, irrespective of age, with similar clinical outcomes in the real world compared to the pivotal trial.

trial registrationClinicalTrials.gov identifier: NCT02537808.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsDexamethasoneLenalidomideMultiple MyelomaAgedAged, 80 and overFemaleHumansMaleMiddle AgedProgression-Free SurvivalProspective StudiesQuality of LifeTreatment OutcomeDexamethasoneLenalidomidedexamethasoneGermanylenalidomidemultiple myelomanon‐interventional studyroutine clinical practicetransplant‐ineligible patients

Identifiers

PMID41927857
PMCPMC13052119

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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.