Evidence map›Paper›PMID 22996335›Full record

Trial reportLeukemia2013

Lenalidomide-prednisone induction followed by lenalidomide-melphalan-prednisone consolidation and lenalidomide-prednisone maintenance in newly diagnosed elderly unfit myeloma patients.

P Falco, F Cavallo, A Larocca, D Rossi, T Guglielmelli, A Rocci, M Grasso, M L M Siez, L De Paoli, S Oliva and 12 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
4.5field-weighted citation impact, top 5% 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.

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

11 citing papers in PubMed, 35 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. New approaches to management of multiple myeloma.Current treatment options in oncology · 2014
    Review
  6. Staging and prognostication of multiple myeloma.Expert review of hematology · 2014
    Review
  7. Consolidation in multiple myeloma - current status and perspectives.Contemporary oncology (Poznan, Poland) · 2014
    Review
  8. Review
  9. Review
  10. Review
  11. In vitro and in vivo antitumor activity of a novel alkylating agent, melphalan-flufenamide, against multiple myeloma cells.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013
    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

22 authors at 9 institutions in 1 country.

P FalcoDivision of Transfusional Medicine and Hematology, Cirié, Italy.
F Cavallo
A Larocca
D Rossi
T Guglielmelli
A Rocci
M Grasso
M L M Siez
L De Paoli
S Oliva
S Molica
R Mina
F Gay
G Benevolo
P Musto
P Omedè
R Freilone
S Bringhen
A M Carella
G Gaidano
M Boccadoro
A Palumbo
Azienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITAzienda Ospedaliera Pugliese Ciaccio · ITAzienda Ospedaliero Universitaria San Giovanni Battista · ITAzienda Sanitaria Ospedaliera S.Croce e Carle Cuneo · ITCentro di Riferimento Oncologico della Basilicata · ITOspedale degli Infermi · ITOspedale Policlinico San Martino · ITOspedale San Luigi Gonzaga · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter phase II trial evaluated the safety and efficacy of lenalidomide-prednisone (RP) induction, followed by lenalidomide-melphalan-prednisone (MPR) consolidation and RP maintenance in elderly unfit newly diagnosed myeloma patients. Patients received four 28-day RP induction courses (lenalidomide 25 mg/day on days 1-21 and prednisone 50 mg three times/week), followed by six 28-day MPR consolidation cycles (melphalan 2 mg, prednisone 50 mg three times/week and lenalidomide 10-15 mg/day on days 1-21), and maintenance with lenalidomide (10 mg/day on days 1-21 every 28 days) plus prednisone (25 mg three times/week). Forty-six patients were enrolled. Median age was 75 years, 59% of patients had at least one comorbidity and 35% at least two. Partial response rate was 80%, including 29% very good partial response. Median time to progression was 19.6 months, median progression-free survival was 18.4 months and 2-year overall survival was 80%. At the tolerated consolidation dose (melphalan 25 mg/month and lenalidomide 10 mg/day), the most frequent grade 3 adverse events were neutropenia (36.4%), anemia (12.1%), cutaneous reactions (18.2%) and infections (12.1%). Grade 4 neutropenia occurred in 12.1% of patients. In conclusion, RP induction followed by MPR consolidation and RP maintenance showed a manageable safety profile, and reduced the risk of severe hematological toxicity in unfit elderly myeloma patients.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansLenalidomideMaleMelphalanMultiple MyelomaNeoplasm StagingPrednisonePrognosisSurvival RateThalidomideLenalidomideMelphalanPrednisoneThalidomide

Identifiers

PMID22996335
OpenAlexW1608567258

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.